Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00328627




Registration number
NCT00328627
Ethics application status
Date submitted
19/05/2006
Date registered
22/05/2006
Date last updated
4/04/2013

Titles & IDs
Public title
Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of SYR-322 (SYR110322) and Pioglitazone HCl (ACTOS®), in Subjects With Type 2 Diabetes
Secondary ID [1] 0 0
2006-000694-30
Secondary ID [2] 0 0
01-05-TL-322OPI-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 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 - Alogliptin
Treatment: Drugs - Alogliptin placebo
Treatment: Drugs - Pioglitazone
Treatment: Drugs - Pioglitazone placebo

Placebo comparator: Placebo - Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.

Experimental: Alogliptin 12.5 + Placebo - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.

Experimental: Alogliptin 25 + Placebo - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.

Active comparator: Placebo + Pioglitazone 15 - Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.

Experimental: Alogliptin 12.5 + Pioglitazone 15 - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.

Experimental: Alogliptin 25 + Pioglitazone 15 - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.

Active comparator: Placebo + Pioglitazone 30 - Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.

Experimental: Alogliptin 12.5 + Pioglitazone 30 - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.

Experimental: Alogliptin 25 + Pioglitazone 30 - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.

Active comparator: Placebo + Pioglitazone 45 - Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.

Experimental: Alogliptin 12.5 + Pioglitazone 45 - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.

Experimental: Alogliptin 25 + Pioglitazone 45 - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.


Treatment: Drugs: Alogliptin
Alogliptin tablets.

Treatment: Drugs: Alogliptin placebo
Alogliptin placebo-matching tablets.

Treatment: Drugs: Pioglitazone
Pioglitazone tablets.

Treatment: Drugs: Pioglitazone placebo
Pioglitazone placebo-matching tablets.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)
Timepoint [1] 0 0
Baseline and Week 26
Primary outcome [2] 0 0
Change From Baseline to Week 26 in HbA1c
Timepoint [2] 0 0
Baseline and Week 26
Secondary outcome [1] 0 0
Change From Baseline in HbA1c Over Time (Grouped Analysis)
Timepoint [1] 0 0
Baseline and Weeks 4, 8, 12, 16 and 20.
Secondary outcome [2] 0 0
Change From Baseline to Week 4 in HbA1c
Timepoint [2] 0 0
Baseline and Week 4
Secondary outcome [3] 0 0
Change From Baseline to Week 8 in HbA1c
Timepoint [3] 0 0
Baseline and Week 8
Secondary outcome [4] 0 0
Change From Baseline to Week 12 in HbA1c
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Change From Baseline to Week 16 in HbA1c
Timepoint [5] 0 0
Baseline and Week 16
Secondary outcome [6] 0 0
Change From Baseline to Week 20 in HbA1c
Timepoint [6] 0 0
Baseline and Week 20
Secondary outcome [7] 0 0
Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis)
Timepoint [7] 0 0
Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Secondary outcome [8] 0 0
Change From Baseline to Week 1 in Fasting Plasma Glucose
Timepoint [8] 0 0
Baseline and Week 1
Secondary outcome [9] 0 0
Change From Baseline to Week 2 in Fasting Plasma Glucose
Timepoint [9] 0 0
Baseline and Week 2
Secondary outcome [10] 0 0
Change From Baseline to Week 4 in Fasting Plasma Glucose
Timepoint [10] 0 0
Baseline and Week 4
Secondary outcome [11] 0 0
Change From Baseline to Week 8 in Fasting Plasma Glucose
Timepoint [11] 0 0
Baseline and Week 8
Secondary outcome [12] 0 0
Change From Baseline to Week 12 in Fasting Plasma Glucose
Timepoint [12] 0 0
Baseline and Week 12
Secondary outcome [13] 0 0
Change From Baseline to Week 16 in Fasting Plasma Glucose
Timepoint [13] 0 0
Baseline and Week 16
Secondary outcome [14] 0 0
Change From Baseline to Week 20 in Fasting Plasma Glucose
Timepoint [14] 0 0
Baseline and Week 20
Secondary outcome [15] 0 0
Change From Baseline to Week 26 in Fasting Plasma Glucose
Timepoint [15] 0 0
Baseline and Week 26
Secondary outcome [16] 0 0
Percentage of Participants With Marked Hyperglycemia (Grouped Analysis)
Timepoint [16] 0 0
From Week 1 to Week 26
Secondary outcome [17] 0 0
Percentage of Participants With Marked Hyperglycemia
Timepoint [17] 0 0
From Week 1 to Week 26
Secondary outcome [18] 0 0
Percentage of Participants Meeting Rescue Criteria (Grouped Analysis)
Timepoint [18] 0 0
From Week 1 to Week 26.
Secondary outcome [19] 0 0
Percentage of Participants Meeting Rescue Criteria
Timepoint [19] 0 0
From Week 1 to Week 26
Secondary outcome [20] 0 0
Percentage of Participants With Glycosylated Hemoglobin = 6.5% (Grouped Analysis)
Timepoint [20] 0 0
Week 26
Secondary outcome [21] 0 0
Percentage of Participants With Glycosylated Hemoglobin = 6.5%
Timepoint [21] 0 0
Week 26
Secondary outcome [22] 0 0
Percentage of Participants With Glycosylated Hemoglobin = 7.0% (Grouped Analysis)
Timepoint [22] 0 0
Week 26
Secondary outcome [23] 0 0
Percentage of Participants With Glycosylated Hemoglobin = 7%
Timepoint [23] 0 0
Week 26
Secondary outcome [24] 0 0
Percentage of Participants With Glycosylated Hemoglobin = 7.5% (Grouped Analysis)
Timepoint [24] 0 0
Week 26
Secondary outcome [25] 0 0
Percentage of Participants With Glycosylated Hemoglobin = 7.5%
Timepoint [25] 0 0
Week 26
Secondary outcome [26] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 0.5% (Grouped Analysis)
Timepoint [26] 0 0
Baseline and Week 26
Secondary outcome [27] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 0.5%
Timepoint [27] 0 0
Baseline and Week 26
Secondary outcome [28] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1% (Grouped Analysis)
Timepoint [28] 0 0
Baseline and Week 26
Secondary outcome [29] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1%
Timepoint [29] 0 0
Baseline and Week 26
Secondary outcome [30] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1.5% (Grouped Analysis)
Timepoint [30] 0 0
Baseline and Week 26
Secondary outcome [31] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 1.5%
Timepoint [31] 0 0
Baseline and Week 26
Secondary outcome [32] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 2.0% (Grouped Analysis)
Timepoint [32] 0 0
Baseline and Week 26.
Secondary outcome [33] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin = 2%
Timepoint [33] 0 0
Baseline and Week 26
Secondary outcome [34] 0 0
Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis)
Timepoint [34] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [35] 0 0
Change From Baseline to Week 4 in Fasting Proinsulin
Timepoint [35] 0 0
Baseline and Week 4
Secondary outcome [36] 0 0
Change From Baseline to Week 8 in Fasting Proinsulin
Timepoint [36] 0 0
Baseline and Week 8
Secondary outcome [37] 0 0
Change From Baseline to Week 12 in Fasting Proinsulin
Timepoint [37] 0 0
Baseline and Week 12
Secondary outcome [38] 0 0
Change From Baseline to Week 16 in Fasting Proinsulin
Timepoint [38] 0 0
Baseline and Week 16
Secondary outcome [39] 0 0
Change From Baseline to Week 20 in Fasting Proinsulin
Timepoint [39] 0 0
Baseline and Week 20
Secondary outcome [40] 0 0
Change From Baseline to Week 26 in Fasting Proinsulin
Timepoint [40] 0 0
Baseline and Week 26
Secondary outcome [41] 0 0
Change From Baseline in Insulin Over Time (Grouped Analysis)
Timepoint [41] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [42] 0 0
Change From Baseline to Week 4 in Insulin Levels
Timepoint [42] 0 0
Baseline and Week 4
Secondary outcome [43] 0 0
Change From Baseline to Week 8 in Insulin Levels
Timepoint [43] 0 0
Baseline and Week 8
Secondary outcome [44] 0 0
Change From Baseline to Week 12 in Insulin Levels
Timepoint [44] 0 0
Baseline and Week 12
Secondary outcome [45] 0 0
Change From Baseline to Week 16 in Insulin Levels
Timepoint [45] 0 0
Baseline and Week 16
Secondary outcome [46] 0 0
Change From Baseline to Week 20 in Insulin Levels
Timepoint [46] 0 0
Baseline and Week 20
Secondary outcome [47] 0 0
Change From Baseline to Week 26 in Insulin Levels
Timepoint [47] 0 0
Baseline and Week 26
Secondary outcome [48] 0 0
Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis)
Timepoint [48] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [49] 0 0
Change From Baseline to Week 4 in Proinsulin/Insulin Ratio
Timepoint [49] 0 0
Baseline and Week 4
Secondary outcome [50] 0 0
Change From Baseline to Week 8 in Proinsulin/Insulin Ratio
Timepoint [50] 0 0
Baseline and Week 8
Secondary outcome [51] 0 0
Change From Baseline to Week 12 in Proinsulin/Insulin Ratio
Timepoint [51] 0 0
Baseline and Week 12
Secondary outcome [52] 0 0
Change From Baseline to Week 16 in Proinsulin/Insulin Ratio
Timepoint [52] 0 0
Baseline and Week 16
Secondary outcome [53] 0 0
Change From Baseline to Week 20 in Proinsulin/Insulin Ratio
Timepoint [53] 0 0
Baseline and Week 20
Secondary outcome [54] 0 0
Change From Baseline to Week 26 in Proinsulin/Insulin Ratio
Timepoint [54] 0 0
Baseline and Week 26
Secondary outcome [55] 0 0
Change From Baseline in C-peptide Over Time (Grouped Analysis)
Timepoint [55] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [56] 0 0
Change From Baseline to Week 4 in C-peptide Levels
Timepoint [56] 0 0
Baseline and Week 4
Secondary outcome [57] 0 0
Change From Baseline to Week 8 in C-peptide Levels
Timepoint [57] 0 0
Baseline and Week 8
Secondary outcome [58] 0 0
Change From Baseline to Week 12 in C-peptide Levels
Timepoint [58] 0 0
Baseline and Week 12
Secondary outcome [59] 0 0
Change From Baseline to Week 16 in C-peptide Levels
Timepoint [59] 0 0
Baseline and Week 16
Secondary outcome [60] 0 0
Change From Baseline to Week 20 in C-peptide Levels
Timepoint [60] 0 0
Baseline and Week 20
Secondary outcome [61] 0 0
Change From Baseline to Week 26 in C-peptide Levels
Timepoint [61] 0 0
Baseline and Week 26
Secondary outcome [62] 0 0
Change From Baseline in Total Cholesterol Over Time (Grouped Analysis)
Timepoint [62] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [63] 0 0
Change From Baseline to Week 4 in Total Cholesterol Levels
Timepoint [63] 0 0
Baseline and Week 4
Secondary outcome [64] 0 0
Change From Baseline to Week 8 in Total Cholesterol Levels
Timepoint [64] 0 0
Baseline and Week 8
Secondary outcome [65] 0 0
Change From Baseline to Week 12 in Total Cholesterol Levels
Timepoint [65] 0 0
Baseline and Week 12
Secondary outcome [66] 0 0
Change From Baseline to Week 16 in Total Cholesterol Levels
Timepoint [66] 0 0
Baseline and Week 16
Secondary outcome [67] 0 0
Change From Baseline to Week 20 in Total Cholesterol Levels
Timepoint [67] 0 0
Baseline and Week 20
Secondary outcome [68] 0 0
Change From Baseline to Week 26 in Total Cholesterol Levels
Timepoint [68] 0 0
Baseline and Week 26
Secondary outcome [69] 0 0
Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)
Timepoint [69] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [70] 0 0
Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol
Timepoint [70] 0 0
Baseline and Week 4
Secondary outcome [71] 0 0
Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol
Timepoint [71] 0 0
Baseline and Week 8
Secondary outcome [72] 0 0
Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol
Timepoint [72] 0 0
Baseline and Week 12
Secondary outcome [73] 0 0
Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol
Timepoint [73] 0 0
Baseline and Week 16
Secondary outcome [74] 0 0
Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol
Timepoint [74] 0 0
Baseline and Week 20
Secondary outcome [75] 0 0
Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol
Timepoint [75] 0 0
Baseline and Week 26
Secondary outcome [76] 0 0
Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)
Timepoint [76] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [77] 0 0
Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol
Timepoint [77] 0 0
Baseline and Week 4
Secondary outcome [78] 0 0
Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol
Timepoint [78] 0 0
Baseline and Week 8
Secondary outcome [79] 0 0
Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol
Timepoint [79] 0 0
Baseline and Week 12
Secondary outcome [80] 0 0
Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol
Timepoint [80] 0 0
Baseline and Week 16
Secondary outcome [81] 0 0
Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol
Timepoint [81] 0 0
Baseline and Week 20
Secondary outcome [82] 0 0
Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol
Timepoint [82] 0 0
Baseline and Week 26
Secondary outcome [83] 0 0
Change From Baseline in Triglycerides Over Time (Grouped Analysis)
Timepoint [83] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [84] 0 0
Change From Baseline to Week 4 in Triglyceride Levels
Timepoint [84] 0 0
Baseline and Week 4
Secondary outcome [85] 0 0
Change From Baseline to Week 8 in Triglyceride Levels
Timepoint [85] 0 0
Baseline and Week 8
Secondary outcome [86] 0 0
Change From Baseline to Week 12 in Triglyceride Levels
Timepoint [86] 0 0
Baseline and Week 12
Secondary outcome [87] 0 0
Change From Baseline to Week 16 in Triglyceride Levels
Timepoint [87] 0 0
Baseline and Week 16
Secondary outcome [88] 0 0
Change From Baseline to Week 20 in Triglyceride Levels
Timepoint [88] 0 0
Baseline and Week 20
Secondary outcome [89] 0 0
Change From Baseline to Week 26 in Triglyceride Levels
Timepoint [89] 0 0
Baseline and Week 26
Secondary outcome [90] 0 0
Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis)
Timepoint [90] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [91] 0 0
Change From Baseline to Week 12 in Free Fatty Acids
Timepoint [91] 0 0
Baseline and Week 12
Secondary outcome [92] 0 0
Change From Baseline to Week 26 in Free Fatty Acids
Timepoint [92] 0 0
Baseline and Week 26
Secondary outcome [93] 0 0
Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis)
Timepoint [93] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [94] 0 0
Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1
Timepoint [94] 0 0
Baseline and Week 12
Secondary outcome [95] 0 0
Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1
Timepoint [95] 0 0
Baseline and Week 26
Secondary outcome [96] 0 0
Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis)
Timepoint [96] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [97] 0 0
Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein
Timepoint [97] 0 0
Baseline and Week 12
Secondary outcome [98] 0 0
Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein
Timepoint [98] 0 0
Baseline and Week 26
Secondary outcome [99] 0 0
Change From Baseline in Adiponectin Over Time (Grouped Analysis)
Timepoint [99] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [100] 0 0
Change From Baseline to Week 12 in Adiponectin
Timepoint [100] 0 0
Baseline and Week 12
Secondary outcome [101] 0 0
Change From Baseline to Week 26 in Adiponectin
Timepoint [101] 0 0
Baseline and Week 26
Secondary outcome [102] 0 0
Change From Baseline in Body Weight Over Time (Grouped Analysis)
Timepoint [102] 0 0
Baseline and Weeks 8, 12, 20 and 26.
Secondary outcome [103] 0 0
Change From Baseline to Week 8 in Body Weight
Timepoint [103] 0 0
Baseline and Week 8
Secondary outcome [104] 0 0
Change From Baseline to Week 12 in Body Weight
Timepoint [104] 0 0
Baseline and Week 12
Secondary outcome [105] 0 0
Change From Baseline to Week 20 in Body Weight
Timepoint [105] 0 0
Baseline and Week 20
Secondary outcome [106] 0 0
Change From Baseline to Week 26 in Body Weight
Timepoint [106] 0 0
Baseline and Week 26
Secondary outcome [107] 0 0
Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis)
Timepoint [107] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [108] 0 0
Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance
Timepoint [108] 0 0
Baseline and Week 12
Secondary outcome [109] 0 0
Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance
Timepoint [109] 0 0
Baseline and Week 26
Secondary outcome [110] 0 0
Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis)
Timepoint [110] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [111] 0 0
Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function
Timepoint [111] 0 0
Baseline and Week 12
Secondary outcome [112] 0 0
Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function
Timepoint [112] 0 0
Baseline and Week 26
Secondary outcome [113] 0 0
Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis)
Timepoint [113] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [114] 0 0
Change From Baseline to Week 12 in Apolipoprotein A1
Timepoint [114] 0 0
Baseline and Week 12
Secondary outcome [115] 0 0
Change From Baseline to Week 26 in Apolipoprotein A1
Timepoint [115] 0 0
Baseline and Week 26
Secondary outcome [116] 0 0
Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis)
Timepoint [116] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [117] 0 0
Change From Baseline to Week 12 in Apolipoprotein A2
Timepoint [117] 0 0
Baseline and Week 12
Secondary outcome [118] 0 0
Change From Baseline to Week 26 in Apolipoprotein A2
Timepoint [118] 0 0
Baseline and Week 26
Secondary outcome [119] 0 0
Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis)
Timepoint [119] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [120] 0 0
Change From Baseline to Week 12 in Apolipoprotein B
Timepoint [120] 0 0
Baseline and Week 12
Secondary outcome [121] 0 0
Change From Baseline to Week 26 in Apolipoprotein B
Timepoint [121] 0 0
Baseline and Week 26
Secondary outcome [122] 0 0
Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis)
Timepoint [122] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [123] 0 0
Change From Baseline to Week 12 in Apolipoprotein C-III
Timepoint [123] 0 0
Baseline and Week 12
Secondary outcome [124] 0 0
Change From Baseline to Week 26 in Apolipoprotein C-III
Timepoint [124] 0 0
Baseline and Week 26
Secondary outcome [125] 0 0
Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis)
Timepoint [125] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [126] 0 0
Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides
Timepoint [126] 0 0
Baseline and Week 12
Secondary outcome [127] 0 0
Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides
Timepoint [127] 0 0
Baseline and Week 26
Secondary outcome [128] 0 0
Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis)
Timepoint [128] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [129] 0 0
Change From Baseline to Week 12 in VLDL / Chylomicron Particles
Timepoint [129] 0 0
Baseline and Week 12
Secondary outcome [130] 0 0
Change From Baseline to Week 26 in VLDL / Chylomicron Particles
Timepoint [130] 0 0
Baseline and Week 26
Secondary outcome [131] 0 0
Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis)
Timepoint [131] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [132] 0 0
Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides
Timepoint [132] 0 0
Baseline and Week 12
Secondary outcome [133] 0 0
Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides
Timepoint [133] 0 0
Baseline and Week 26
Secondary outcome [134] 0 0
Change From Baseline in VLDL Particles Over Time (Grouped Analysis)
Timepoint [134] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [135] 0 0
Change From Baseline to Week 12 in VLDL Particles
Timepoint [135] 0 0
Baseline and Week 12
Secondary outcome [136] 0 0
Change From Baseline to Week 26 in VLDL Particles
Timepoint [136] 0 0
Baseline and Week 26
Secondary outcome [137] 0 0
Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis)
Timepoint [137] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [138] 0 0
Change From Baseline to Week 12 in Mean VLDL Particle Size
Timepoint [138] 0 0
Baseline and Week 12
Secondary outcome [139] 0 0
Change From Baseline to Week 26 in Mean VLDL Particle Size
Timepoint [139] 0 0
Baseline and Week 26
Secondary outcome [140] 0 0
Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis)
Timepoint [140] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [141] 0 0
Change From Baseline to Week 12 in IDL Particles
Timepoint [141] 0 0
Baseline and Week 12
Secondary outcome [142] 0 0
Change From Baseline to Week 26 in IDL Particles
Timepoint [142] 0 0
Baseline and Week 26
Secondary outcome [143] 0 0
Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis)
Timepoint [143] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [144] 0 0
Change From Baseline to Week 12 in LDL Particles
Timepoint [144] 0 0
Baseline and Week 12
Secondary outcome [145] 0 0
Change From Baseline to Week 26 in LDL Particles
Timepoint [145] 0 0
Baseline and Week 26
Secondary outcome [146] 0 0
Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis)
Timepoint [146] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [147] 0 0
Change From Baseline to Week 12 in Mean LDL Particle Size
Timepoint [147] 0 0
Baseline and Week 12
Secondary outcome [148] 0 0
Change From Baseline to Week 26 in Mean LDL Particle Size
Timepoint [148] 0 0
Baseline and Week 26
Secondary outcome [149] 0 0
Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis)
Timepoint [149] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [150] 0 0
Change From Baseline to Week 12 in HDL Particles
Timepoint [150] 0 0
Baseline and Week 12
Secondary outcome [151] 0 0
Change From Baseline to Week 26 in HDL Particles
Timepoint [151] 0 0
Baseline and Week 26
Secondary outcome [152] 0 0
Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis)
Timepoint [152] 0 0
Baseline and Weeks 12 and 26
Secondary outcome [153] 0 0
Change From Baseline to Week 12 in Mean HDL Particle Size
Timepoint [153] 0 0
Baseline and Week 12
Secondary outcome [154] 0 0
Change From Baseline to Week 26 in Mean HDL Particle Size
Timepoint [154] 0 0
Baseline and Week 26

Eligibility
Key inclusion criteria
* Men or women with a historical diagnosis of type 2 diabetes mellitus who were treated with metformin greater than or equal to 1500 mg alone but were experiencing inadequate glycemic control.
* A stable dose of metformin of greater than or equal to 1500 mg or maximum tolerated dose.
* No treatment with antidiabetic agents other than metformin within the 2 months prior to Screening.
* A body mass index greater than or equal to 23 kg/m^2 and less than or equal to 45 kg/m^2.
* Fasting C-peptide greater than or equal to 0.8 ng/mL.
* Regular use of other, non-excluded medications was allowed if a stable dose had been established for at least 4 weeks prior to Screening.
* Systolic blood pressure less than or equal to 160 mmHg and diastolic pressure less than or equal to 100 mmHg.
* Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 10 g/dL for women.
* Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.
* Serum creatinine less than 1.5 mg/dL for men and less than 1.4 mg/dL for women.
* Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject was clinically euthyroid.
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
* Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
* No major illness or debility that in the investigator's opinion prohibited the patient from completing the study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Urine albumin/creatinine ratio greater than 113 mg/mmol at Screening.
* A history of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 5 years prior to Screening.
* A history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
* A history of treated diabetic gastroparesis.
* New York Heart Association Class III or IV heart failure regardless of therapy.
* History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
* History of any hemoglobinopathy.
* History of infection with hepatitis B, hepatitis C or human immunodeficiency virus.
* History of a psychiatric disorder that could have affected the patient's ability to participate in the study.
* History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
* A history of alcohol or substance abuse within 2 years prior to Screening.
* Receipt of any investigational drug within 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within 3 months prior to Screening.
* Previous participation in an investigational study of alogliptin.
* Hypersensitive to pioglitazone, alogliptin, or other excipients.

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
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
1554
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Multiple Cities
Recruitment postcode(s) [1] 0 0
- Multiple Cities
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
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
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
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
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
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
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
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
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
Utah
Country [28] 0 0
United States of America
State/province [28] 0 0
Vermont
Country [29] 0 0
Brazil
State/province [29] 0 0
Multiple Cities
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Multiple Cities
Country [31] 0 0
Chile
State/province [31] 0 0
Multiple Cities
Country [32] 0 0
Croatia
State/province [32] 0 0
Multiple Cities
Country [33] 0 0
Estonia
State/province [33] 0 0
Multiple Cities
Country [34] 0 0
Guatemala
State/province [34] 0 0
Multiple Cities
Country [35] 0 0
India
State/province [35] 0 0
Multiple Cities
Country [36] 0 0
Israel
State/province [36] 0 0
Multiple Cities
Country [37] 0 0
Latvia
State/province [37] 0 0
Multiple Cities
Country [38] 0 0
Mexico
State/province [38] 0 0
Multiple Cities
Country [39] 0 0
New Zealand
State/province [39] 0 0
Multiple Cities
Country [40] 0 0
Peru
State/province [40] 0 0
Multiple Cities
Country [41] 0 0
Romania
State/province [41] 0 0
Multiple Cities
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Multiple Cities
Country [43] 0 0
Serbia
State/province [43] 0 0
Multiple Cities
Country [44] 0 0
South Africa
State/province [44] 0 0
Multiple Cities
Country [45] 0 0
Ukraine
State/province [45] 0 0
Multiple Cities

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.
Trial website
https://clinicaltrials.gov/study/NCT00328627
Trial related presentations / publications
DeFronzo RA, Burant CF, Fleck P, Wilson C, Mekki Q, Pratley RE. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 May;97(5):1615-22. doi: 10.1210/jc.2011-2243. Epub 2012 Mar 14.
Public notes

Contacts
Principal investigator
Name 0 0
VP Biological Sciences
Address 0 0
Takeda
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/NCT00328627