CompletedNCT01263470Updated Feb 3, 2012Results posted

Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan

A Phase 2 interventional study of Alogliptin and Alogliptin in Diabetes Mellitus, Type 2, sponsored by Takeda. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-02-03.

Sponsored by Takeda · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 480
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study summary

The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.

Read the detailed description

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.

Conditions studied

Diabetes Mellitus, Type 2

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Keywords

Diabetes Mellitus - Type 2
Diabetes Mellitus
Drug Therapy

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 480 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Exclusion criteria

Exclusion Criteria:

Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 480 participants (actual)

Study arms

Placebo comparator
Placebo
Drug: Placebo
Experimental
Alogliptin 6.25 mg QD
Drug: Alogliptin
Experimental
Alogliptin 12.5 mg QD
Drug: Alogliptin
Experimental
Alogliptin 25 mg QD
Drug: Alogliptin
Experimental
Alogliptin 50 mg QD
Drug: Alogliptin
Active comparator
Voglibose 0.2 mg TID
Drug: Voglibose

Interventions

DrugAlogliptin
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Also known as: SYR-322
DrugAlogliptin
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Also known as: SYR-322
DrugAlogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Also known as: SYR-322
DrugAlogliptin
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
Also known as: SYR-322
DrugVoglibose
Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Also known as: Voglib, BASEN®
DrugPlacebo
Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.

What researchers measure

Primary outcomes

Change From Baseline in Glycosylated Hemoglobin (Week 12).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 12.

Secondary outcomes

Change From Baseline in Glycosylated Hemoglobin (Week 2).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 2.
Change From Baseline in Glycosylated Hemoglobin (Week 4).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 4.
Change From Baseline in Glycosylated Hemoglobin (Week 8).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 2).
The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 2
Change From Baseline in Fasting Plasma Glucose (Week 4).
The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 4.
Change From Baseline in Fasting Plasma Glucose (Week 8).
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 12).
The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 12.
Change From Baseline in Fasting C-peptide (Week 2).
The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 2.
Change From Baseline in Fasting C-peptide (Week 4).
The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 4.
Change From Baseline in Fasting C-peptide (Week 8).
The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 8.
Change From Baseline in Fasting C-peptide (Week 12).
The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.
Time frame: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).
The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time frame: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).
The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Time frame: Baseline and Week 12.
Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).
The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Time frame: Baseline and Week 12
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).
The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Time frame: Baseline and Week 12.
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).
The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Time frame: Baseline and Week 12

Results

Posted Jul 6, 2011

Participant flow

Participants enrolled at 54 investigative sites in Japan from 17 January 2007 to 22 December 2007.

Participant flow — Overall Study
Milestone	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Started	75	79	84	80	79	83
Completed	73	74	80	77	76	78
Not completed	2	5	4	3	3	5
Withdrew: Adverse event	2	2	1	1	2	2
Withdrew: Protocol violation	0	1	0	0	0	1
Withdrew: Withdrawal by subject	0	1	1	2	0	2
Withdrew: Lack of efficacy	0	0	2	0	0	0
Withdrew: Participant unavailability	0	1	0	0	0	0
Withdrew: Study drug non-compliance	0	0	0	0	1	0

Outcome measures

PrimaryChange From Baseline in Glycosylated Hemoglobin (Week 12).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.

Time frame:: Baseline and Week 12.
Reported as:: Mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin (Week 12).
percentage of Glycosylated Hemoglobin	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Glycosylated Hemoglobin (Week 12).	0.06 ± 0.456	-0.51 ± 0.677	-0.70 ± 0.572	-0.76 ± 0.547	-0.82 ± 0.474	-0.16 ± 0.730

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -0.570 · 95% CI -0.755 to -0.386
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -0.762 · 95% CI -0.925 to -0.598
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): -0.826 · 95% CI -0.987 to -0.665
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -0.887 · 95% CI -1.035 to -0.739
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.351 · 95% CI -0.570 to -0.132
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.542 · 95% CI -0.743 to -0.342
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.607 · 95% CI -0.808 to -0.406
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.667 · 95% CI -0.859 to -0.475

SecondaryChange From Baseline in Glycosylated Hemoglobin (Week 2).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.

Time frame:: Baseline and Week 2.
Reported as:: Mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin (Week 2).
percentage of Glycosylated Hemoglobin	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Glycosylated Hemoglobin (Week 2).	0.00 ± 0.187	-0.16 ± 0.153	-0.17 ± 0.194	-0.16 ± 0.187	-0.15 ± 0.180	-0.10 ± 0.204

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -0.158 · 95% CI -0.213 to -0.104
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -0.174 · 95% CI -0.234 to -0.114
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): -0.160 · 95% CI -0.219 to -0.100
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -0.153 · 95% CI -0.212 to -0.095
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.059 · 95% CI -0.116 to -0.003
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.075 · 95% CI -0.136 to -0.014
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.061 · 95% CI -0.121 to 0.000
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.054 · 95% CI -0.114 to 0.006

SecondaryChange From Baseline in Glycosylated Hemoglobin (Week 4).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.

Time frame:: Baseline and Week 4.
Reported as:: Mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin (Week 4).
percentage of Glycosylated Hemoglobin	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Glycosylated Hemoglobin (Week 4).	-0.01 ± 0.336	-0.34 ± 0.243	-0.38 ± 0.309	-0.35 ± 0.281	-0.40 ± 0.284	-0.16 ± 0.395

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -0.326 · 95% CI -0.419 to -0.233
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -0.369 · 95% CI -0.470 to -0.268
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): -0.340 · 95% CI -0.438 to -0.241
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -0.387 · 95% CI -0.485 to -0.288
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.178 · 95% CI -0.280 to -0.076
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.221 · 95% CI -0.329 to -0.112
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.192 · 95% CI -0.299 to -0.085
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.239 · 95% CI -0.346 to -0.131

SecondaryChange From Baseline in Glycosylated Hemoglobin (Week 8).

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.

Time frame:: Baseline and Week 8.
Reported as:: Mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin (Week 8).
percentage of Glycosylated Hemoglobin	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Glycosylated Hemoglobin (Week 8).	0.00 ± 0.473	-0.50 ± 0.432	-0.61 ± 0.481	-0.66 ± 0.432	-0.69 ± 0.382	-0.17 ± 0.634

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -0.500 · 95% CI -0.644 to -0.356
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -0.614 · 95% CI -0.763 to -0.464
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): -0.660 · 95% CI -0.804 to -0.516
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -0.695 · 95% CI -0.832 to -0.559
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.325 · 95% CI -0.494 to -0.156
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.438 · 95% CI -0.610 to -0.267
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.485 · 95% CI -0.654 to -0.315
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -0.520 · 95% CI -0.683 to -0.357

SecondaryChange From Baseline in Fasting Plasma Glucose (Week 2).

The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.

Time frame:: Baseline and Week 2
Reported as:: Mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 2).
mg/dL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Fasting Plasma Glucose (Week 2).	1.8 ± 28.26	-13.8 ± 19.31	-15.9 ± 20.26	-14.3 ± 22.13	-21.7 ± 25.65	-8.0 ± 24.34

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -15.60 · 95% CI -23.27 to -7.93
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -17.69 · 95% CI -25.34 to -10.05
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): -16.08 · 95% CI -24.14 to -8.02
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -23.47 · 95% CI -32.06 to -14.89
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -5.82 · 95% CI -12.66 to 1.02
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -7.92 · 95% CI -14.76 to -1.08
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -6.30 · 95% CI -13.53 to 0.93
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -13.69 · 95% CI -21.45 to -5.94

SecondaryChange From Baseline in Fasting Plasma Glucose (Week 4).

The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.

Time frame:: Baseline and Week 4.
Reported as:: Mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 4).
mg/dL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Fasting Plasma Glucose (Week 4).	8.4 ± 30.74	-16.0 ± 20.88	-20.9 ± 19.78	-19.0 ± 20.64	-23.3 ± 23.40	-7.2 ± 26.77

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -15.60 · 95% CI -23.27 to -7.93
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -17.69 · 95% CI -25.34 to -10.05
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): -16.08 · 95% CI -24.14 to -8.02
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -23.47 · 95% CI -32.06 to -14.89
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -5.82 · 95% CI -12.66 to 1.02
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -7.92 · 95% CI -14.76 to -1.08
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -6.30 · 95% CI -13.53 to 0.93
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -13.69 · 95% CI -21.45 to -5.94

SecondaryChange From Baseline in Fasting Plasma Glucose (Week 8).

The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.

Time frame:: Baseline and Week 8.
Reported as:: Mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 8).
mg/dL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Fasting Plasma Glucose (Week 8).	5.7 ± 27.40	-12.0 ± 27.77	-18.5 ± 22.71	-18.6 ± 20.58	-22.6 ± 27.60	-3.5 ± 28.45

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -17.73 · 95% CI -26.52 to -8.94
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -24.22 · 95% CI -32.07 to -16.37
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): -24.34 · 95% CI -32.03 to -16.65
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -28.28 · 95% CI -37.04 to -19.52
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -8.55 · 95% CI -17.28 to 0.18
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -15.04 · 95% CI -22.90 to -7.18
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -15.16 · 95% CI -22.90 to -7.42
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -19.10 · 95% CI -27.80 to -10.40

SecondaryChange From Baseline in Fasting Plasma Glucose (Week 12).

The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.

Time frame:: Baseline and Week 12.
Reported as:: Mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 12).
mg/dL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Fasting Plasma Glucose (Week 12).	5.6 ± 25.26	-9.3 ± 32.36	-14.6 ± 23.80	-17.5 ± 20.71	-22.6 ± 24.24	-3.0 ± 27.69

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -14.92 · 95% CI -24.19 to -5.64
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -20.17 · 95% CI -27.86 to -12.48
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): -23.07 · 95% CI -30.41 to -15.73
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -28.17 · 95% CI -36.05 to -20.29
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -6.27 · 95% CI -15.60 to 3.06
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -11.52 · 95% CI -19.41 to -3.64
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -14.42 · 95% CI -22.04 to -6.80
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -19.52 · 95% CI -27.61 to -11.43

SecondaryChange From Baseline in Fasting C-peptide (Week 2).

The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.

Time frame:: Baseline and Week 2.
Reported as:: Mean · ng/mL

Change From Baseline in Fasting C-peptide (Week 2).
ng/mL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Fasting C-peptide (Week 2).	0.04 ± 0.772	-0.11 ± 0.731	0.17 ± 0.756	0.18 ± 0.776	0.04 ± 0.619	-0.11 ± 0.830

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -0.145 · 95% CI -0.384 to 0.094
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): 0.134 · 95% CI -0.106 to 0.374
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): 0.144 · 95% CI -0.103 to 0.390
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): 0.004 · 95% CI -0.218 to 0.227
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.002 · 95% CI -0.241 to 0.245
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.281 · 95% CI 0.038 to 0.524
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.291 · 95% CI 0.041 to 0.540
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.151 · 95% CI -0.077 to 0.380

SecondaryChange From Baseline in Fasting C-peptide (Week 4).

The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.

Time frame:: Baseline and Week 4.
Reported as:: Mean · ng/mL

Change From Baseline in Fasting C-peptide (Week 4).
ng/mL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Fasting C-peptide (Week 4).	0.01 ± 0.624	-0.04 ± 0.634	0.02 ± 0.636	0.16 ± 0.697	0.05 ± 0.554	-0.16 ± 0.767

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -0.045 · 95% CI -0.245 to 0.156
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): 0.012 · 95% CI -0.185 to 0.210
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): 0.158 · 95% CI -0.053 to 0.369
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): 0.048 · 95% CI -0.140 to 0.235
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.122 · 95% CI -0.097 to 0.341
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.179 · 95% CI -0.036 to 0.395
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.325 · 95% CI 0.097 to 0.553
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.215 · 95% CI 0.006 to 0.423

SecondaryChange From Baseline in Fasting C-peptide (Week 8).

The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.

Time frame:: Baseline and Week 8.
Reported as:: Mean · ng/mL

Change From Baseline in Fasting C-peptide (Week 8).
ng/mL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Fasting C-peptide (Week 8).	0.17 ± 0.882	0.05 ± 1.144	0.07 ± 0.792	0.24 ± 0.646	0.05 ± 0.592	-0.05 ± 0.804

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -0.117 · 95% CI -0.444 to 0.209
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -0.100 · 95% CI -0.362 to 0.162
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): 0.079 · 95% CI -0.166 to 0.324
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -0.117 · 95% CI -0.355 to 0.121
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.102 · 95% CI -0.203 to 0.408
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.120 · 95% CI -0.124 to 0.364
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.299 · 95% CI 0.071 to 0.526
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.102 · 95% CI -0.118 to 0.322

SecondaryChange From Baseline in Fasting C-peptide (Week 12).

The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.

Time frame:: Baseline and Week 12.
Reported as:: Mean · ng/mL

Change From Baseline in Fasting C-peptide (Week 12).
ng/mL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Fasting C-peptide (Week 12).	-0.00 ± 0.692	0.04 ± 0.967	0.17 ± 0.609	0.25 ± 0.591	0.18 ± 0.696	-0.02 ± 0.888

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): 0.039 · 95% CI -0.230 to 0.308
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): 0.175 · 95% CI -0.029 to 0.379
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): 0.248 · 95% CI 0.044 to 0.453
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): 0.186 · 95% CI -0.035 to 0.407
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.052 · 95% CI -0.236 to 0.340
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.188 · 95% CI -0.044 to 0.421
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.261 · 95% CI 0.026 to 0.496
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.199 · 95% CI -0.049 to 0.448

SecondaryChange From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).

The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.

Time frame:: Baseline and Week 12.
Reported as:: Mean · mg/dL

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).
mg/dL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).	-4.2 ± 42.10	-28.1 ± 49.50	-27.6 ± 43.88	-44.8 ± 36.04	-47.0 ± 32.66	-22.7 ± 40.58

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -23.85 · 95% CI -38.75 to -8.94
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -23.38 · 95% CI -37.14 to -9.61
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): -40.60 · 95% CI -53.18 to -28.02
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -42.75 · 95% CI -54.93 to -30.58
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -5.36 · 95% CI -19.70 to 8.98
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -4.89 · 95% CI -18.13 to 8.35
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -22.11 · 95% CI -34.22 to -10.01
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -24.27 · 95% CI -35.98 to -12.55

SecondaryChange From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).

Time frame:: Baseline and Week 12.
Reported as:: Mean · mg·hr/dL

Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).
mg·hr/dL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).	5.6 ± 62.45	-52.7 ± 75.51	-55.0 ± 63.73	-73.1 ± 51.21	-81.8 ± 53.69	-50.0 ± 62.49

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): -58.31 · 95% CI -80.79 to -35.83
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): -60.66 · 95% CI -80.84 to -40.47
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): -78.72 · 95% CI -97.03 to -60.40
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -87.43 · 95% CI -106.26 to -68.60
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -2.73 · 95% CI -24.69 to 19.23
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -5.07 · 95% CI -24.85 to 14.70
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -23.13 · 95% CI -41.16 to -5.11
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -31.84 · 95% CI -50.36 to -13.33

SecondaryChange From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).

The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

Time frame:: Baseline and Week 12
Reported as:: Mean · μU·hr/mL

Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).
μU·hr/mL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).	-3.60 ± 12.940	-0.74 ± 19.745	1.86 ± 15.602	4.12 ± 14.057	-1.04 ± 23.333	-15.40 ± 20.416

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): 2.859 · 95% CI -2.736 to 8.455
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): 5.456 · 95% CI 0.748 to 10.165
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): 7.715 · 95% CI 3.181 to 12.248
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): 2.557 · 95% CI -3.763 to 8.877
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 14.660 · 95% CI 7.924 to 21.396
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 17.257 · 95% CI 11.353 to 23.160
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 19.515 · 95% CI 13.629 to 25.401
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 14.357 · 95% CI 7.013 to 21.701

SecondaryChange From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).

The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

Time frame:: Baseline and Week 12.
Reported as:: Mean · ng·hr/mL

Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).
ng·hr/mL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).	0.01 ± 1.628	0.54 ± 1.787	0.77 ± 1.804	1.01 ± 1.957	0.97 ± 1.642	-0.39 ± 2.091

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): 0.535 · 95% CI -0.019 to 1.089
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): 0.764 · 95% CI 0.214 to 1.315
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): 0.999 · 95% CI 0.418 to 1.580
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): 0.959 · 95% CI 0.430 to 1.489
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 0.934 · 95% CI 0.315 to 1.552
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 1.163 · 95% CI 0.551 to 1.774
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 1.398 · 95% CI 0.759 to 2.036
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 1.358 · 95% CI 0.760 to 1.956

SecondaryChange From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).

The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.

Time frame:: Baseline and Week 12
Reported as:: Mean · pg·hr/mL

Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).
pg·hr/mL	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).	-15.8 ± 36.91	-11.5 ± 37.45	-4.5 ± 38.54	-12.6 ± 47.23	-19.5 ± 40.47	-16.3 ± 52.26

Statistical analysis

Placebo vs Alogliptin 6.25 mg QD · Mean difference (final values): 4.25 · 95% CI -7.87 to 16.38
Placebo vs Alogliptin 12.5 mg QD · Mean difference (final values): 11.26 · 95% CI -0.90 to 23.42
Placebo vs Alogliptin 25 mg QD · Mean difference (final values): 3.19 · 95% CI -10.56 to 16.95
Placebo vs Alogliptin 50 mg QD · Mean difference (final values): -3.66 · 95% CI -16.27 to 8.94
Alogliptin 6.25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 4.75 · 95% CI -9.79 to 19.29
Alogliptin 12.5 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 11.76 · 95% CI -2.67 to 26.19
Alogliptin 25 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): 3.69 · 95% CI -12.02 to 19.40
Alogliptin 50 mg QD vs Voglibose 0.2 mg TID · Mean difference (final values): -3.17 · 95% CI -18.04 to 11.71

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	1/75 (1.3%)	20/75 (26.7%)
Alogliptin 6.25 mg QD	—	2/79 (2.5%)	17/79 (21.5%)
Alogliptin 12.5 mg QD	—	2/84 (2.4%)	23/84 (27.4%)
Alogliptin 25 mg QD	—	1/80 (1.3%)	27/80 (33.8%)
Alogliptin 50 mg QD	—	2/79 (2.5%)	23/79 (29.1%)
Voglibose 0.2 mg TID	—	2/83 (2.4%)	38/83 (45.8%)

Most frequent serious events

Most frequent serious events
Event	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
Bile duct stoneHepatobiliary disorders	1/75	0/79	0/84	0/80	0/79	0/83
GastroenteritisInfections and infestations	0/75	0/79	0/84	0/80	1/79	0/83
Cerebral infarctionNervous system disorders	0/75	1/79	0/84	0/80	0/79	0/83
MeningiomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/75	1/79	0/84	0/80	0/79	0/83
Papillary thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/75	0/79	0/84	0/80	1/79	0/83
Crohn's diseaseGastrointestinal disorders	0/75	0/79	0/84	1/80	0/79	0/83
PneumoniaInfections and infestations	0/75	0/79	0/84	0/80	0/79	1/83
Breast cancer femaleNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/75	0/79	0/84	0/80	0/79	1/83
Inguinal herniaGastrointestinal disorders	0/75	0/79	1/84	0/80	0/79	0/83
CholelithiasisHepatobiliary disorders	0/75	0/79	1/84	0/80	0/79	0/83

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID
NasopharyngitisInfections and infestations	5/75	5/79	7/84	10/80	8/79	4/83
FlatulenceGastrointestinal disorders	2/75	2/79	4/84	1/80	1/79	8/83
ConstipationGastrointestinal disorders	1/75	1/79	1/84	1/80	1/79	7/83
HeadacheNervous system disorders	4/75	2/79	0/84	5/80	0/79	1/83
Blood creatine phosphokinase increasedInvestigations	2/75	1/79	2/84	1/80	4/79	4/83
Abdominal distensionGastrointestinal disorders	0/75	1/79	2/84	3/80	2/79	4/83
GastritisGastrointestinal disorders	3/75	0/79	0/84	0/80	0/79	3/83
BronchitisInfections and infestations	1/75	3/79	2/84	0/80	2/79	0/83
Abdominal pain upperGastrointestinal disorders	0/75	1/79	1/84	3/80	2/79	1/83
MalaiseGeneral disorders	0/75	0/79	0/84	3/80	0/79	0/83

Baseline characteristics

Age, Customized
Age, Customized(participants)	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID	Total
≤ 64 years	48	58	56	52	54	51	319
≥ 65 years	27	21	28	28	25	32	161

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Alogliptin 6.25 mg QD	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Alogliptin 50 mg QD	Voglibose 0.2 mg TID	Total
Female	19	23	25	17	24	27	135
Male	56	56	59	63	55	56	345

Study locations

1 site

Okayama, 701-0192, Japan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01263470
Lead sponsor: Takeda
Responsible party: Sponsor
First posted: Dec 20, 2010
Start date: Jan 2007
Primary completion: Dec 2007
Completion: Dec 2007
Results posted: Jul 6, 2011
Last update: Feb 3, 2012

Study contacts

Professor, Department of Medicine

study director · Kawasaki Medical School

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan

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