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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01541215




Registration number
NCT01541215
Ethics application status
Date submitted
23/02/2012
Date registered
29/02/2012

Titles & IDs
Public title
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
Scientific title
Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes
Secondary ID [1] 0 0
2011-002605-29
Secondary ID [2] 0 0
NN2211-3659
Universal Trial Number (UTN)
Trial acronym
Ellipse™
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - liraglutide
Treatment: Drugs - placebo
Treatment: Drugs - metformin

Experimental: Lira + Met -

Placebo comparator: Placebo + Met -


Treatment: Drugs: liraglutide
Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.

Treatment: Drugs: placebo
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.

Treatment: Drugs: metformin
Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c (Glycosylated Haemoglobin)
Assessment method [1] 0 0
Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [1] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG)
Assessment method [1] 0 0
Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [1] 0 0
Week 0, week 26
Secondary outcome [2] 0 0
Number of Subjects Having HbA1c Below 7.0%
Assessment method [2] 0 0
Percentage of subjects having HbA1c \<7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [2] 0 0
Week 26
Secondary outcome [3] 0 0
Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)
Assessment method [3] 0 0
Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [3] 0 0
Week 0, week 26
Secondary outcome [4] 0 0
Number of Subjects Having HbA1c Below 7.0%
Assessment method [4] 0 0
Number of subjects achieving HbA1c \<7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Number of Subjects Having HbA1c Maximum 6.5%
Assessment method [5] 0 0
Number of subjects achieving HbA1c \<=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [5] 0 0
Week 26
Secondary outcome [6] 0 0
Number of Subjects Having HbA1c Maximum 6.5%
Assessment method [6] 0 0
Number of subjects achieving HbA1c \<=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Assessment method [7] 0 0
Number of subjects achieving HbA1c \<7.0% without severe or minor hypoglycaemic episodes after 26 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: 1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself 2. any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [7] 0 0
Week 26
Secondary outcome [8] 0 0
Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes
Assessment method [8] 0 0
Number of subjects achieving HbA1c \<7.0% without severe or minor hypoglycaemic episodes after 52 weeks. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemia was defined as meeting either of the below criteria: 1. an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself 2. any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [8] 0 0
Week 52
Secondary outcome [9] 0 0
Number of Subjects Having HbA1c Below 7.5%
Assessment method [9] 0 0
Number of subjects achieving HbA1c \<7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [9] 0 0
Week 26
Secondary outcome [10] 0 0
Number of Subjects Having HbA1c Below 7.5%
Assessment method [10] 0 0
Number of subjects achieving HbA1c \<7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Change in HbA1c
Assessment method [11] 0 0
Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [11] 0 0
Week 0, week 52
Secondary outcome [12] 0 0
Change in FPG
Assessment method [12] 0 0
Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [12] 0 0
Week 0, week 52
Secondary outcome [13] 0 0
Change in Mean 7-point Self-measured Plasma Glucose
Assessment method [13] 0 0
Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [13] 0 0
Week 0, week 26
Secondary outcome [14] 0 0
Change From Baseline in 7-point Self-measured Plasma Glucose
Assessment method [14] 0 0
Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [14] 0 0
Week 0, week 52
Secondary outcome [15] 0 0
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Assessment method [15] 0 0
Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [15] 0 0
Week 0, week 26
Secondary outcome [16] 0 0
Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)
Assessment method [16] 0 0
Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [16] 0 0
Week 0, week 52
Secondary outcome [17] 0 0
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
Assessment method [17] 0 0
Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [17] 0 0
Week 0, week 26
Secondary outcome [18] 0 0
Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)
Assessment method [18] 0 0
Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [18] 0 0
Week 0, week 52
Secondary outcome [19] 0 0
Change From Baseline in Body Weight
Assessment method [19] 0 0
Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [19] 0 0
Week 0, week 26
Secondary outcome [20] 0 0
Change From Baseline in Body Weight
Assessment method [20] 0 0
Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [20] 0 0
Week 0, week 52
Secondary outcome [21] 0 0
Change From Baseline in BMI Standard Deviation Score (SDS)
Assessment method [21] 0 0
Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [21] 0 0
Week 0, week 52
Secondary outcome [22] 0 0
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Assessment method [22] 0 0
Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [22] 0 0
Week 0, week 26
Secondary outcome [23] 0 0
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Assessment method [23] 0 0
Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [23] 0 0
Week 0, week 52
Secondary outcome [24] 0 0
Ratio to Baseline: Fasting Insulin
Assessment method [24] 0 0
Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [24] 0 0
Week 0, week 26
Secondary outcome [25] 0 0
Ratio to Baseline: Fasting Insulin
Assessment method [25] 0 0
Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [25] 0 0
Week 0, week 52
Secondary outcome [26] 0 0
Ratio to Baseline: Fasting Pro-insulin
Assessment method [26] 0 0
Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [26] 0 0
Week 0, week 26
Secondary outcome [27] 0 0
Ratio to Baseline: Fasting Pro-insulin
Assessment method [27] 0 0
Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [27] 0 0
Week 0, week 52
Secondary outcome [28] 0 0
Ratio to Baseline: Pro-insulin/Insulin Ratio
Assessment method [28] 0 0
Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [28] 0 0
Week 0, week 26
Secondary outcome [29] 0 0
Ratio to Baseline: Pro-insulin/Insulin Ratio
Assessment method [29] 0 0
Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [29] 0 0
Week 0, week 52
Secondary outcome [30] 0 0
Ratio to Baseline: Fasting Glucagon
Assessment method [30] 0 0
Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [30] 0 0
Week 0, week 26
Secondary outcome [31] 0 0
Ratio to Baseline: Fasting Glucagon
Assessment method [31] 0 0
Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [31] 0 0
Week 0, week 52
Secondary outcome [32] 0 0
Ratio to Baseline: Fasting C-peptide
Assessment method [32] 0 0
Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [32] 0 0
Week 0, week 26
Secondary outcome [33] 0 0
Ratio to Baseline: Fasting C-peptide
Assessment method [33] 0 0
Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [33] 0 0
Week 0, week 52
Secondary outcome [34] 0 0
Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
Assessment method [34] 0 0
Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [34] 0 0
Week 0, week 26
Secondary outcome [35] 0 0
Ratio to Baseline: HOMA-B
Assessment method [35] 0 0
Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [35] 0 0
Week 0, week 52
Secondary outcome [36] 0 0
Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
Assessment method [36] 0 0
Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [36] 0 0
Week 0, week 26
Secondary outcome [37] 0 0
Ratio to Baseline: HOMA-IR
Assessment method [37] 0 0
Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [37] 0 0
Week 0, week 52
Secondary outcome [38] 0 0
Ratio to Baseline: Total Cholesterol
Assessment method [38] 0 0
Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [38] 0 0
Week 0, week 26
Secondary outcome [39] 0 0
Ratio to Baseline: Total Cholesterol
Assessment method [39] 0 0
Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [39] 0 0
Week 0, week 52
Secondary outcome [40] 0 0
Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol
Assessment method [40] 0 0
Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [40] 0 0
Week 0, week 26
Secondary outcome [41] 0 0
Ratio to Baseline: LDL Cholesterol
Assessment method [41] 0 0
Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [41] 0 0
Week 0, week 52
Secondary outcome [42] 0 0
Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol
Assessment method [42] 0 0
Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [42] 0 0
Week 0, week 26
Secondary outcome [43] 0 0
Ratio to Baseline: VLDL Cholesterol
Assessment method [43] 0 0
Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [43] 0 0
Week 0, week 52
Secondary outcome [44] 0 0
Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol
Assessment method [44] 0 0
Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [44] 0 0
Week 0, week 26
Secondary outcome [45] 0 0
Ratio to Baseline: HDL Cholesterol
Assessment method [45] 0 0
Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [45] 0 0
Week 0, week 52
Secondary outcome [46] 0 0
Ratio to Baseline: Triglycerides
Assessment method [46] 0 0
Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [46] 0 0
Week 0, week 26
Secondary outcome [47] 0 0
Ratio to Baseline: Triglycerides
Assessment method [47] 0 0
Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [47] 0 0
Week 0, week 52
Secondary outcome [48] 0 0
Ratio to Baseline: Free Fatty Acids
Assessment method [48] 0 0
Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [48] 0 0
Week 0, week 26
Secondary outcome [49] 0 0
Ratio to Baseline: Free Fatty Acids
Assessment method [49] 0 0
Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [49] 0 0
Week 0, week 52
Secondary outcome [50] 0 0
Change From Baseline in Pulse
Assessment method [50] 0 0
Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [50] 0 0
Week 0, week 26
Secondary outcome [51] 0 0
Change From Baseline in Pulse
Assessment method [51] 0 0
Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [51] 0 0
Week 0, week 52
Secondary outcome [52] 0 0
Change From Baseline in Height SDS
Assessment method [52] 0 0
Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [52] 0 0
Week 0, week 26
Secondary outcome [53] 0 0
Change From Baseline in Height SDS
Assessment method [53] 0 0
Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [53] 0 0
Week 0, week 52
Secondary outcome [54] 0 0
Change in Bone Age Assessment (X-ray of Left Hand and Wrist)
Assessment method [54] 0 0
Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52.
Timepoint [54] 0 0
Week 0, week 52
Secondary outcome [55] 0 0
Pubertal Assessment/Progression (Tanner Staging)
Assessment method [55] 0 0
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52.
Timepoint [55] 0 0
Week 0, week 26, week 52
Secondary outcome [56] 0 0
Growth (Height Velocity)
Assessment method [56] 0 0
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
Timepoint [56] 0 0
Week 0, week 26
Secondary outcome [57] 0 0
Growth (Height Velocity)
Assessment method [57] 0 0
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.
Timepoint [57] 0 0
Week 0, week 52
Secondary outcome [58] 0 0
Height Velocity SDS
Assessment method [58] 0 0
Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [58] 0 0
Week 0, week 26
Secondary outcome [59] 0 0
Height Velocity SDS
Assessment method [59] 0 0
Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.
Timepoint [59] 0 0
Week 0, week 52
Secondary outcome [60] 0 0
Number of Hypoglycaemic Episodes
Assessment method [60] 0 0
Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26.
Timepoint [60] 0 0
0-26 weeks
Secondary outcome [61] 0 0
Number of Hypoglycaemic Episodes
Assessment method [61] 0 0
Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52.
Timepoint [61] 0 0
0-52 weeks
Secondary outcome [62] 0 0
Number of Adverse Events (Week 0-26)
Assessment method [62] 0 0
Total number of adverse events during 26 weeks.
Timepoint [62] 0 0
0-26 weeks
Secondary outcome [63] 0 0
Number of Adverse Events (Week 0-52)
Assessment method [63] 0 0
Total number of adverse events during entire treatment period.
Timepoint [63] 0 0
0-52 weeks
Secondary outcome [64] 0 0
Number of Serious Adverse Events (Week 0-26)
Assessment method [64] 0 0
Total number of serious adverse events during 26 weeks.
Timepoint [64] 0 0
0-26 weeks
Secondary outcome [65] 0 0
Number of Serious Adverse Events (Week 0-52)
Assessment method [65] 0 0
Total number of serious adverse events during entire treatment period.
Timepoint [65] 0 0
0-52 weeks
Secondary outcome [66] 0 0
Number of Adverse Events (Week 53-104)
Assessment method [66] 0 0
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during follow-up 1 (week 53 to 104).
Timepoint [66] 0 0
Week 53-104
Secondary outcome [67] 0 0
Number of Serious Adverse Events (Week 53-104)
Assessment method [67] 0 0
This outcome is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during follow up 1 (week 53 to 104).
Timepoint [67] 0 0
Weeks 53-104
Secondary outcome [68] 0 0
Growth (Height Velocity)- Week 104
Assessment method [68] 0 0
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Timepoint [68] 0 0
Week 0, week 104
Secondary outcome [69] 0 0
Height Velocity SDS- Week 104
Assessment method [69] 0 0
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Timepoint [69] 0 0
Week 0, week 104
Secondary outcome [70] 0 0
Change From Week 52 in Height SDS- Week 104
Assessment method [70] 0 0
Change in height SDS from week 52 to week 104. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Timepoint [70] 0 0
Week 52, week 104
Secondary outcome [71] 0 0
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104
Assessment method [71] 0 0
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Timepoint [71] 0 0
Week 52, week 104
Secondary outcome [72] 0 0
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104
Assessment method [72] 0 0
Change in bone age from week 52 to week 104. This outcome is applicable only for the Liraglutide 1.8 mg treatment arm.
Timepoint [72] 0 0
Week 52, week 104
Secondary outcome [73] 0 0
Number of Adverse Events (Week 53-156)
Assessment method [73] 0 0
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of adverse events reported during the follow-up period (weeks 53 to 156).
Timepoint [73] 0 0
Week 53-156
Secondary outcome [74] 0 0
Number of Serious Adverse Events (Week 53-156)
Assessment method [74] 0 0
This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm. Number of serious adverse events reported during the follow up period (week 53 to 156).
Timepoint [74] 0 0
Weeks 53-156
Secondary outcome [75] 0 0
Growth (Height Velocity)- Week 156
Assessment method [75] 0 0
Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Timepoint [75] 0 0
Week 0, week 156
Secondary outcome [76] 0 0
Height Velocity SDS- Week 156
Assessment method [76] 0 0
The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Timepoint [76] 0 0
Week 0, week 156
Secondary outcome [77] 0 0
Change From Week 52 in Height SDS- Week 156
Assessment method [77] 0 0
Change in height SDS from week 52 to week 156. Height SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Timepoint [77] 0 0
Week 52, week 156
Secondary outcome [78] 0 0
Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156
Assessment method [78] 0 0
Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V, where stage I represents "pre-adoloscent development" and stage V represents "pubertal development equivalent to that of an adult". The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of subjects at different Tanner stages at week 52 and week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Timepoint [78] 0 0
Week 52, week 156
Secondary outcome [79] 0 0
Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156
Assessment method [79] 0 0
Change in bone age from week 52 to week 156. This outcome measure is applicable only for the Liraglutide 1.8 mg treatment arm.
Timepoint [79] 0 0
Week 52, week 156

Eligibility
Key inclusion criteria
- Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - Body mass index (BMI) above 85% percentile of the general age and gender matched population
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/05/2020
Sample size
Target
Accrual to date
Final
135
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Ipswich
Recruitment postcode(s) [1] 0 0
4305 - Ipswich
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
South Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
West Virginia
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
Country [30] 0 0
Austria
State/province [30] 0 0
Innsbruck
Country [31] 0 0
Austria
State/province [31] 0 0
Salzburg
Country [32] 0 0
Austria
State/province [32] 0 0
Wels
Country [33] 0 0
Belgium
State/province [33] 0 0
Brussel
Country [34] 0 0
Belgium
State/province [34] 0 0
Bruxelles
Country [35] 0 0
Belgium
State/province [35] 0 0
Leuven
Country [36] 0 0
Brazil
State/province [36] 0 0
Rio Grande Do Sul
Country [37] 0 0
Canada
State/province [37] 0 0
Alberta
Country [38] 0 0
Canada
State/province [38] 0 0
Manitoba
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
Croatia
State/province [41] 0 0
Rijeka
Country [42] 0 0
Croatia
State/province [42] 0 0
Zagreb
Country [43] 0 0
Denmark
State/province [43] 0 0
Herlev
Country [44] 0 0
Denmark
State/province [44] 0 0
Næstved
Country [45] 0 0
Egypt
State/province [45] 0 0
Alexandria
Country [46] 0 0
Egypt
State/province [46] 0 0
Cairo
Country [47] 0 0
Egypt
State/province [47] 0 0
Mansoura
Country [48] 0 0
France
State/province [48] 0 0
Marseille
Country [49] 0 0
France
State/province [49] 0 0
MONTPELLIER cedex 05
Country [50] 0 0
Germany
State/province [50] 0 0
Ludwigshafen
Country [51] 0 0
Germany
State/province [51] 0 0
Mayen
Country [52] 0 0
Greece
State/province [52] 0 0
Athens
Country [53] 0 0
Greece
State/province [53] 0 0
Goudi/ Athens
Country [54] 0 0
Greece
State/province [54] 0 0
Thessaloniki
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Hungary
State/province [56] 0 0
Miskolc
Country [57] 0 0
Hungary
State/province [57] 0 0
Szombathely
Country [58] 0 0
India
State/province [58] 0 0
Andhra Pradesh
Country [59] 0 0
India
State/province [59] 0 0
Karnataka
Country [60] 0 0
India
State/province [60] 0 0
Maharashtra
Country [61] 0 0
India
State/province [61] 0 0
New Delhi
Country [62] 0 0
India
State/province [62] 0 0
Punjab
Country [63] 0 0
India
State/province [63] 0 0
Rajasthan
Country [64] 0 0
India
State/province [64] 0 0
Tamil Nadu
Country [65] 0 0
India
State/province [65] 0 0
Telengana
Country [66] 0 0
India
State/province [66] 0 0
West Bengal
Country [67] 0 0
India
State/province [67] 0 0
Kolkata
Country [68] 0 0
Israel
State/province [68] 0 0
Beer Sheva
Country [69] 0 0
Israel
State/province [69] 0 0
Haifa
Country [70] 0 0
Israel
State/province [70] 0 0
Jerusalem
Country [71] 0 0
Israel
State/province [71] 0 0
Petah Tikva
Country [72] 0 0
Israel
State/province [72] 0 0
Tel Hashomer
Country [73] 0 0
Italy
State/province [73] 0 0
Roma
Country [74] 0 0
Lebanon
State/province [74] 0 0
Hazmieh
Country [75] 0 0
Lebanon
State/province [75] 0 0
Lebanon - Beirut
Country [76] 0 0
Malaysia
State/province [76] 0 0
Kuala Lumpur
Country [77] 0 0
Mexico
State/province [77] 0 0
Tamaulipas
Country [78] 0 0
Mexico
State/province [78] 0 0
Puebla
Country [79] 0 0
Morocco
State/province [79] 0 0
Fès
Country [80] 0 0
Morocco
State/province [80] 0 0
Rabat
Country [81] 0 0
Netherlands
State/province [81] 0 0
Den Bosch
Country [82] 0 0
New Zealand
State/province [82] 0 0
Grafton
Country [83] 0 0
North Macedonia
State/province [83] 0 0
Skopje
Country [84] 0 0
Norway
State/province [84] 0 0
Bergen
Country [85] 0 0
Poland
State/province [85] 0 0
Katowice
Country [86] 0 0
Poland
State/province [86] 0 0
Warszawa
Country [87] 0 0
Poland
State/province [87] 0 0
Wroclaw
Country [88] 0 0
Portugal
State/province [88] 0 0
Braga
Country [89] 0 0
Portugal
State/province [89] 0 0
Lisboa
Country [90] 0 0
Puerto Rico
State/province [90] 0 0
Ponce
Country [91] 0 0
Romania
State/province [91] 0 0
Timis
Country [92] 0 0
Romania
State/province [92] 0 0
Bucharest
Country [93] 0 0
Romania
State/province [93] 0 0
Constanta
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Chelyabinsk
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Izhevsk
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Krasnoyarsk
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Moscow
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Novosibirsk
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Saint-Petersburg
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Saratov
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Tomsk
Country [102] 0 0
Serbia
State/province [102] 0 0
Belgrade
Country [103] 0 0
Serbia
State/province [103] 0 0
Nis
Country [104] 0 0
Serbia
State/province [104] 0 0
Novi Sad
Country [105] 0 0
Spain
State/province [105] 0 0
Leganés
Country [106] 0 0
Spain
State/province [106] 0 0
Madrid
Country [107] 0 0
Spain
State/province [107] 0 0
Vigo
Country [108] 0 0
Spain
State/province [108] 0 0
Vitoria
Country [109] 0 0
Sweden
State/province [109] 0 0
Göteborg
Country [110] 0 0
Sweden
State/province [110] 0 0
Huddinge
Country [111] 0 0
Sweden
State/province [111] 0 0
Uppsala
Country [112] 0 0
Taiwan
State/province [112] 0 0
Tainan city
Country [113] 0 0
Taiwan
State/province [113] 0 0
Taoyuan
Country [114] 0 0
Thailand
State/province [114] 0 0
Bangkok
Country [115] 0 0
Thailand
State/province [115] 0 0
Chiang Mai
Country [116] 0 0
Turkey
State/province [116] 0 0
Ankara
Country [117] 0 0
Turkey
State/province [117] 0 0
Istanbul
Country [118] 0 0
Turkey
State/province [118] 0 0
Kocaeli
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Birmingham
Country [120] 0 0
United Kingdom
State/province [120] 0 0
London
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Manchester
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Norwich
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01541215