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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01511692




Registration number
NCT01511692
Ethics application status
Date submitted
12/01/2012
Date registered
19/01/2012
Date last updated
25/01/2017

Titles & IDs
Public title
Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes
Scientific title
A 4 Week Single Center, Double-dummy, Randomised Double-blind, Balanced Incomplete Latin Square Design Study to Evaluate the Effects of Liraglutide on Appetite in Subjects With Type 2 Diabetes Compared to Glimepiride and Placebo
Secondary ID [1] 0 0
2006-000377-30
Secondary ID [2] 0 0
NN2211-1589
Universal Trial Number (UTN)
Trial acronym
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 - placebo
Treatment: Drugs - glimepiride

Experimental: Lira --> placebo -

Placebo comparator: Placebo --> glim -

Active comparator: Glim --> lira -


Treatment: Drugs: liraglutide
1.8 mg/day injected subcutaneously for 4 weeks

Treatment: Drugs: placebo
Liraglutide placebo, injected subcutaneously for 4 weeks

Treatment: Drugs: placebo
Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks

Treatment: Drugs: glimepiride
Dose individually adjusted, administered orally for 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Timepoint [1] 0 0
Secondary outcome [1] 0 0
The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Total duration of eating at the buffet meal (satiation)
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Weight
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Waist circumference
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Adverse events
Timepoint [7] 0 0

Eligibility
Key inclusion criteria
* Type 2 diabetes mellitus
* Diet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy
* HbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive)
* Body mass index (BMI) between 27-40 kg/m^2 (both inclusive)
* Subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)
* Euthyroid subjects
* Subjects should be unrestrained eaters
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Recurrent severe hypoglycaemia
* Impaired liver function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Known or suspected allergy to trial products or related products
* Use of any drug (except for OADs), which in the investigator's opinion could interfere with the subject's glucose level or body weight
* Active hepatitis B and/or active hepatitis C
* Positive HIV (human immunodeficiency virus) antibodies
* Known or suspected abuse of alcohol or narcotics
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the Investigator

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
Crossover
Other design features
Phase
Phase 1
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
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2007
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5005 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Neuss

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

Ethics approval
Ethics application status

Summary
Brief summary
This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes.
Trial website
https://clinicaltrials.gov/study/NCT01511692
Trial related presentations / publications
Horowitz M, Flint A, Jones KL, Hindsberger C, Rasmussen MF, Kapitza C, Doran S, Jax T, Zdravkovic M, Chapman IM. Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes. Diabetes Res Clin Pract. 2012 Aug;97(2):258-66. doi: 10.1016/j.diabres.2012.02.016. Epub 2012 Mar 24.
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01511692