CompletedNCT00286429Updated Feb 3, 2012Results posted

Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

A Phase 3 interventional study of Alogliptin and insulin and Alogliptin and insulin in Diabetes Mellitus, sponsored by Takeda. Completed at 60 sites in 16 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-02-03.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 390
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.

Read the detailed description

There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a marked increase in the number of adults with diabetes mellitus is expected.

Takeda is developing alogliptin (SYR-322) for patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase 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 dipeptidyl peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes.

The aim of the current study is to evaluate the efficacy of alogliptin in combination with insulin in subjects who are inadequately controlled on insulin alone (with or without metformin). Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center. Study participation is anticipated to be about 34 weeks (or 8.5 months).

Conditions studied

Diabetes Mellitus

Browse trials for

Diabetes Mellitus 10,925

Keywords

Glucose Metabolism Disorder
Dysmetabolic Syndrome
Type II Diabetes
Diabetes Mellitus
Lipoatrophic
Dyslipidemia
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 390 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: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnosis of type 2 diabetes mellitus and currently treated with insulin alone (with or without metformin), and is inadequately controlled. Metformin dose must be stable for at least 8 weeks prior to Randomization.
No treatment with antidiabetic agents other than insulin and metformin within the 8 weeks prior to Randomization.
Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2
Fasting C-peptide concentration greater than or equal to 0.8 ng per mL. (If this screening criterion is not met, the subject still qualifies if C-peptide greater than or equal to 1.5 ng per mL after a challenge test).
Glycosylated hemoglobin concentration greater than or equal to 8.0% at Screening.
Using a stable dose of insulin of at least 15 units but not more than 100 units per day for at least 8 weeks prior to Randomization. A dose of insulin that varies by up to 15% of the mean will be considered as stable.
If regular use of other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening. However, as needed use of prescription or over-the-counter medications is allowed at the discretion of the investigator.
Systolic blood pressure less than or equal to180 mm Hg and diastolic pressure less than or equal to 110 mm Hg
Hemoglobin greater than or equal to 12 g per dL for males and greater than or equal to10 g per dL for females.
Alanine aminotransferase less than or equal to 3 times the upper limit of normal.
Serum creatinine less than or equal to 2.0 mg per dL.
Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.
Neither pregnant (confirmed by laboratory testing in females of childbearing potential) nor lactating.
Female subjects of childbearing potential must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study.
Able and willing to monitor own blood glucose concentrations with a home glucose monitor
No major illness or debility that in the investigator's opinion prohibits the individual from completing the study
Able and willing to provide written informed consent

Exclusion criteria

Exclusion Criteria

Urine albumin to creatinine ratio of greater than 1000 μg per mg at Screening. If elevated, the subject may be rescreened within 1 week.
History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening. (History of treated cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is allowed.).
History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
History of treated diabetic gastric paresis.
New York Heart Association Class III or IV heart failure regardless of therapy. Currently treated subjects who are stable at Class I or II are candidates for the study.
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
History of a psychiatric disorder that will affect ability to participate in the study.
History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
History of alcohol or substance abuse within the 2 years prior to Screening.
Receipt of any investigational drug within the 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within the 3 months prior to Screening.
Prior treatment in an investigational study of alogliptin.
Excluded Medications:
- Treatment with antidiabetic agents other than insulin and metformin is not allowed within the 8 weeks prior to Randomization and through the completion of the end-of treatment or early termination procedures. (Exception: if has received other antidiabetic therapy for less than 7 days within the 3 months prior to Screening.)
- Treatment with weight-loss drugs, any investigational antidiabetics, or oral or systemically injected glucocorticoids is not allowed from 3 months prior to randomization through the completion of the end-of-treatment or early termination procedures. Inhaled corticosteroids are allowed.
- Must not take any medications, including over-the-counter products, without first consulting with the investigator.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 390 participants (actual)

Study arms

Placebo comparator
Insulin
Drug: Insulin
Experimental
Alogliptin 12.5 mg QD
Drug: Alogliptin and insulin
Experimental
Alogliptin 25 mg QD
Drug: Alogliptin and insulin

Interventions

DrugAlogliptin and insulin
Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
Also known as: alogliptin, SYR110322
DrugAlogliptin and insulin
Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
Also known as: alogliptin, SYR110322
DrugInsulin
Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.

What researchers measure

Primary outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
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 26 or final visit and glycosylated hemoglobin collected at baseline.
Time frame: Baseline and Week 26.

Secondary outcomes

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 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 and Glycosylated Hemoglobin collected at baseline.
Time frame: Baseline and Week 12.
Change From Baseline in Glycosylated Hemoglobin (Week 16).
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 16 and Glycosylated Hemoglobin collected at baseline.
Time frame: Baseline and Week 16.
Change From Baseline in Glycosylated Hemoglobin (Week 20).
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 20 and Glycosylated Hemoglobin collected at baseline.
Time frame: Baseline and Week 20.
Change From Baseline in Fasting Plasma Glucose (Week 1).
The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 1.
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 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 12.
Change From Baseline in Fasting Plasma Glucose (Week 16).
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 16.
Change From Baseline in Fasting Plasma Glucose (Week 20).
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 20.
Change From Baseline in Fasting Plasma Glucose (Week 26).
The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.
Time frame: Baseline and Week 26.
Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).
The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.
Time frame: 26 Weeks.
Number of Participants Requiring Rescue.
The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.
Time frame: 26 Weeks.
Change From Baseline in C-peptide (Week 4).
The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.
Time frame: Baseline and Week 4.
Change From Baseline in C-peptide (Week 8).
The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.
Time frame: Baseline and Week 8.
Change From Baseline in C-peptide (Week 12).
The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.
Time frame: Baseline and Week 12.
Change From Baseline in C-peptide (Week 16).
The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.
Time frame: Baseline and Week 16.
Change From Baseline in C-peptide (Week 20).
The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.
Time frame: Baseline and Week 20.
Change From Baseline in C-peptide (Week 26).
The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.
Time frame: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.
Time frame: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.
Time frame: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.
Time frame: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.
Time frame: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.
Time frame: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.
Time frame: Baseline and Week 26.
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.
Time frame: Baseline and Week 26.
Change From Baseline in Body Weight (Week 8).
The change between Body Weight measured at week 8 and Body Weight measured at baseline.
Time frame: Baseline and Week 8.
Change From Baseline in Body Weight (Week 12).
The change between Body Weight measured at week 12 and Body Weight measured at baseline.
Time frame: Baseline and Week 12.
Change From Baseline in Body Weight (Week 20).
The change between Body Weight measured at week 20 and Body Weight measured at baseline.
Time frame: Baseline and Week 20.
Change From Baseline in Body Weight (Week 26).
The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.
Time frame: Baseline and Week 26.

Results

Posted Aug 12, 2011

Participant flow

Participants enrolled at 110 investigative sites in Australia, Brazil, Chile, Guatemala, Germany, Hungary, India, Mexico, New Zealand, the Netherlands, Poland, South Africa, and the United States from 16 March 2006 to 18 September 2006

Participant flow — Overall Study
Milestone	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Started	130	131	129
Completed	55	83	77
Not completed	75	48	52
Withdrew: Adverse event	4	1	6
Withdrew: Lack of efficacy	52	27	25
Withdrew: Lost to follow-up	2	4	3
Withdrew: Physician decision	10	7	7
Withdrew: Protocol violation	3	5	4
Withdrew: Withdrawal by subject	3	2	6
Withdrew: Administrative error	1	1	1
Withdrew: Administrative decision	0	1	0

Outcome measures

PrimaryChange From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.

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 26 or final visit and glycosylated hemoglobin collected at baseline.

Time frame:: Baseline and Week 26.
Reported as:: Least squares mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
percentage of Glycosylated Hemoglobin	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.	-0.13 ± 0.077	-0.63 ± 0.076	-0.71 ± 0.078

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = <0.001 (A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.) · Mean difference (final values): -0.51 · 95% CI -0.72 to -0.30Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = <0.001 (A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.) · Mean difference (final values): -0.59 · 95% CI -0.80 to -0.37Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

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:: Least squares mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin (Week 4).
percentage of Glycosylated Hemoglobin	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Glycosylated Hemoglobin (Week 4).	-0.26 ± 0.045	-0.47 ± 0.045	-0.58 ± 0.045

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments) · Mean difference (final values): -0.21 · 95% CI -0.34 to -0.09Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments.) · Mean difference (final values): -0.32 · 95% CI -0.45 to -0.20Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

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:: Least squares mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin (Week 8).
percentage of Glycosylated Hemoglobin	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Glycosylated Hemoglobin (Week 8).	-0.27 ± 0.061	-0.76 ± 0.060	-0.84 ± 0.062

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments.) · Mean difference (final values): -0.48 · 95% CI -0.65 to -0.31Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments.) · Mean difference (final values): -0.56 · 95% CI -0.73 to -0.39Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange 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 and Glycosylated Hemoglobin collected at baseline.

Time frame:: Baseline and Week 12.
Reported as:: Least squares mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin (Week 12).
percentage of Glycosylated Hemoglobin	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Glycosylated Hemoglobin (Week 12).	-0.27 ± 0.073	-0.84 ± 0.072	-0.81 ± 0.073

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments.) · Mean difference (final values): -0.57 · 95% CI -0.77 to -0.37Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments.) · Mean difference (final values): -0.54 · 95% CI -0.75 to -0.34Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in Glycosylated Hemoglobin (Week 16).

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 16 and Glycosylated Hemoglobin collected at baseline.

Time frame:: Baseline and Week 16.
Reported as:: Least squares mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin (Week 16).
percentage of Glycosylated Hemoglobin	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Glycosylated Hemoglobin (Week 16).	-0.22 ± 0.076	-0.80 ± 0.074	-0.76 ± 0.076

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments.) · Mean difference (final values): -0.58 · 95% CI -0.79 to -0.37Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments.) · Mean difference (final values): -0.54 · 95% CI -0.75 to -0.33Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in Glycosylated Hemoglobin (Week 20).

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 20 and Glycosylated Hemoglobin collected at baseline.

Time frame:: Baseline and Week 20.
Reported as:: Least squares mean · percentage of Glycosylated Hemoglobin

Change From Baseline in Glycosylated Hemoglobin (Week 20).
percentage of Glycosylated Hemoglobin	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Glycosylated Hemoglobin (Week 20).	-0.17 ± 0.078	-0.76 ± 0.076	-0.74 ± 0.078

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments.) · Mean difference (final values): -0.59 · 95% CI -0.80 to -0.37Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments.) · Mean difference (final values): -0.57 · 95% CI -0.79 to -0.35Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in Fasting Plasma Glucose (Week 1).

The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.

Time frame:: Baseline and Week 1.
Reported as:: Least squares mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 1).
mg/dL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Fasting Plasma Glucose (Week 1).	6.3 ± 5.40	-5.0 ± 5.07	-9.9 ± 5.33

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.128 (No multiplicity adjustments.) · Mean difference (final values): -11.3 · 95% CI -25.9 to 3.3Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.034 (No multiplicity adjustments.) · Mean difference (final values): -16.1 · 95% CI -31.1 to -1.2Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

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:: Least squares mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 2).
mg/dL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Fasting Plasma Glucose (Week 2).	1.0 ± 5.09	-3.1 ± 4.84	-11.4 ± 5.03

Statistical analysis

Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.563 (No multiplicity adjustments.) · Mean difference (final values): -4.1 · 95% CI -17.9 to 9.7Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.084 (No multiplicity adjustments.) · Mean difference (final values): -12.4 · 95% CI -26.4 to 1.7Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

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:: Least squares mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 4).
mg/dL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Fasting Plasma Glucose (Week 4).	5.3 ± 5.28	-5.0 ± 5.08	-12.1 ± 5.28

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.160 (No multiplicity adjustments.) · Mean difference (final values): -10.3 · 95% CI -24.7 to 4.1Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.020 (No multiplicity adjustments.) · Mean difference (final values): -17.4 · 95% CI -32.1 to -2.8Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

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:: Least squares mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 8).
mg/dL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Fasting Plasma Glucose (Week 8).	5.4 ± 5.42	-13.5 ± 5.26	-14.1 ± 5.39

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.013 (No multiplicity adjustments.) · Mean difference (final values): -18.9 · 95% CI -33.7 to -4.0Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.011 (No multiplicity adjustments.) · Mean difference (final values): -19.5 · 95% CI -34.5 to -4.5Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

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

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

Time frame:: Baseline and Week 12.
Reported as:: Least squares mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 12).
mg/dL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Fasting Plasma Glucose (Week 12).	-1.4 ± 5.47	-5.2 ± 5.38	-2.9 ± 5.47

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.624 (No multiplicity adjustments.) · Mean difference (final values): -3.8 · 95% CI -18.9 to 11.3Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.853 (No multiplicity adjustments.) · Mean difference (final values): -1.4 · 95% CI -16.7 to 13.8Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in Fasting Plasma Glucose (Week 16).

The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.

Time frame:: Baseline and Week 16.
Reported as:: Least squares mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 16).
mg/dL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Fasting Plasma Glucose (Week 16).	4.6 ± 5.38	-5.3 ± 5.29	-6.3 ± 5.38

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.190 (No multiplicity adjustments.) · Mean difference (final values): -9.9 · 95% CI -24.7 to 4.9Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.154 (No multiplicity adjustments.) · Mean difference (final values): -10.9 · 95% CI -25.8 to 4.1Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in Fasting Plasma Glucose (Week 20).

The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.

Time frame:: Baseline and Week 20.
Reported as:: Least squares mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 20).
mg/dL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Fasting Plasma Glucose (Week 20).	8.6 ± 5.45	-4.2 ± 5.36	-11.3 ± 5.46

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.097 (No multiplicity adjustments.) · Mean difference (final values): -12.7 · 95% CI -27.8 to 2.3Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.010 (No multiplicity adjustments.) · Mean difference (final values): -19.9 · 95% CI -35.1 to -4.7Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in Fasting Plasma Glucose (Week 26).

The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.

Time frame:: Baseline and Week 26.
Reported as:: Least squares mean · mg/dL

Change From Baseline in Fasting Plasma Glucose (Week 26).
mg/dL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Fasting Plasma Glucose (Week 26).	5.8 ± 5.69	2.3 ± 5.59	-11.7 ± 5.69

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.662 (No multiplicity adjustments.) · Mean difference (final values): -3.5 · 95% CI -19.2 to 12.2Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.030 (No multiplicity adjustments.) · Mean difference (final values): -17.6 · 95% CI -33.4 to -1.7Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryNumber of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).

The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.

Time frame:: 26 Weeks.
Reported as:: Number · participants

Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).
participants	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).	105	99	86

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · Regression, Logistic · p = 0.075 (No multiplicity adjustments.) · Odds ratio (or): 0.551 · 95% CI 0.286 to 1.063Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.
Placebo vs Alogliptin 25 mg QD · Regression, Logistic · p = 0.002 (No multiplicity adjustments.) · Odds ratio (or): 0.364 · 95% CI 0.191 to 0.695Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.

SecondaryNumber of Participants Requiring Rescue.

The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.

Time frame:: 26 Weeks.
Reported as:: Number · participants

Number of Participants Requiring Rescue.
participants	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Number of Participants Requiring Rescue.	52	27	25

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD vs Alogliptin 25 mg QD · Regression, Logistic · p = <0.001 (No multiplicity adjustments.) · Odds ratio (or): 0.350 · 95% CI 0.198 to 0.619Odds Ratio (OR) is alogliptin arm versus placebo arm. OR \<1.0 indicates lower incidence compared to placebo.
Placebo vs Alogliptin 25 mg QD · Regression, Logistic · p = <0.001 (No multiplicity adjustments.) · Odds ratio (or): 0.339 · 95% CI 0.189 to 0.608Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.

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

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

Time frame:: Baseline and Week 4.
Reported as:: Least squares mean · ng/mL

Change From Baseline in C-peptide (Week 4).
ng/mL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in C-peptide (Week 4).	-0.023 ± 0.1062	0.132 ± 0.1001	0.453 ± 0.1014

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.286 (No multiplicity adjustments.) · Mean difference (final values): 0.156 · 95% CI -0.131 to 0.443Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.001 (No multiplicity adjustments.) · Mean difference (final values): .477 · 95% CI 0.188 to 0.765Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

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

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

Time frame:: Baseline and Week 8.
Reported as:: Least squares mean · ng/mL

Change From Baseline in C-peptide (Week 8).
ng/mL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in C-peptide (Week 8).	-0.024 ± 0.1224	0.178 ± 0.1180	0.348 ± 0.1220

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.236 (No multiplicity adjustments.) · Mean difference (final values): 0.202 · 95% CI -0.132 to 0.536Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.032 (No multiplicity adjustments.) · Mean difference (final values): 0.372 · 95% CI 0.032 to 0.712Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

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

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

Time frame:: Baseline and Week 12.
Reported as:: Least squares mean · ng/mL

Change From Baseline in C-peptide (Week 12).
ng/mL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in C-peptide (Week 12).	0.207 ± 0.1558	0.333 ± 0.1521	0.390 ± 0.1553

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.562 (No multiplicity adjustments.) · Mean difference (final values): 0.126 · 95% CI -0.302 to 0.554Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.407 (No multiplicity adjustments.) · Mean difference (final values): 0.183 · 95% CI -0.251 to 0.616Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in C-peptide (Week 16).

The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.

Time frame:: Baseline and Week 16.
Reported as:: Least squares mean · ng/mL

Change From Baseline in C-peptide (Week 16).
ng/mL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in C-peptide (Week 16).	0.241 ± 0.1536	0.319 ± 0.1500	0.396 ± 0.1532

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.716 (No multiplicity adjustments.) · Mean difference (final values): 0.078 · 95% CI -0.344 to 0.500Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.474 (No multiplicity adjustments.) · Mean difference (final values): 0.156 · 95% CI -0.272 to 0.583Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in C-peptide (Week 20).

The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.

Time frame:: Baseline and Week 20.
Reported as:: Least squares mean · ng/mL

Change From Baseline in C-peptide (Week 20).
ng/mL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in C-peptide (Week 20).	0.239 ± 0.1467	0.318 ± 0.1432	0.281 ± 0.1463

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.700 (No multiplicity adjustments.) · Mean difference (final values): 0.079 · 95% CI -0.324 to 0.482Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.839 (No multiplicity adjustments.) · Mean difference (final values): 0.042 · 95% CI -0.366 to 0.450Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in C-peptide (Week 26).

The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.

Time frame:: Baseline and Week 26.
Reported as:: Least squares mean · ng/mL

Change From Baseline in C-peptide (Week 26).
ng/mL	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in C-peptide (Week 26).	-0.083 ± 0.1192	0.199 ± 0.1164	0.042 ± 0.1189

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.091 (No multiplicity adjustments.) · Mean difference (final values): 0.282 · 95% CI -0.045 to 0.610Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.459 (No multiplicity adjustments.) · Mean difference (final values): 0.125 · 95% CI -0.207 to 0.457Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryNumber of Participants With Glycosylated Hemoglobin ≤ 6.5%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.

Time frame:: Baseline and Week 26.
Reported as:: Number · participants

Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.
participants	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.	0	3	3

SecondaryNumber of Participants With Glycosylated Hemoglobin ≤ 7.0%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.

Time frame:: Baseline and Week 26.
Reported as:: Number · participants

Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.
participants	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.	1	11	10

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · Regression, Logistic · p = 0.016 (No multiplicity adjustments.) · Odds ratio (or): 12.650 · 95% CI 1.589 to 100.682Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.
Placebo vs Alogliptin 25 mg QD · Regression, Logistic · p = 0.023 (No multiplicity adjustments.) · Odds ratio (or): 11.255 · 95% CI 1.401 to 90.379Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.

SecondaryNumber of Participants With Glycosylated Hemoglobin ≤ 7.5%.

The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.

Time frame:: Baseline and Week 26.
Reported as:: Number · participants

Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.
participants	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.	5	22	33

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = <0.001 (No multiplicity adjustments.) · Odds ratio (or): 5.777 · 95% CI 2.047 to 16.305Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.
Placebo vs Alogliptin 25 mg QD · Regression, Logistic · p = <0.001 (No multiplicity adjustments.) · Odds ratio (or): 9.784 · 95% CI 3.540 to 27.039Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.

SecondaryNumber of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.

The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.

Time frame:: Baseline and Week 26.
Reported as:: Number · participants

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.
participants	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.	40	70	70

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD vs Alogliptin 25 mg QD · Regression, Logistic · p = <0.001 (No multiplicity adjustments.) · Odds ratio (or): 2.674 · 95% CI 1.579 to 4.530Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.
Placebo vs Alogliptin 25 mg QD · Regression, Logistic · p = <0.001 (No multiplicity adjustments.) · Odds ratio (or): 2.819 · 95% CI 1.653 to 4.808Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.

SecondaryNumber of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.

Time frame:: Baseline and Week 26.
Reported as:: Number · participants

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.
participants	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.	17	41	47

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD vs Alogliptin 25 mg QD · Regression, Logistic · p = <0.001 (No multiplicity adjustments.) · Odds ratio (or): 3.163 · 95% CI 1.651 to 6.060Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.
Placebo vs Alogliptin 25 mg QD · Regression, Logistic · p = <0.001 (No multiplicity adjustments.) · Odds ratio (or): 3.989 · 95% CI 2.083 to 7.640Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.

SecondaryNumber of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.

Time frame:: Baseline and Week 26.
Reported as:: Number · participants

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.
participants	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.	6	22	23

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · Regression, Logistic · p = 0.002 (No multiplicity adjustments.) · Odds ratio (or): 4.550 · 95% CI 1.732 to 11.953Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.
Placebo vs Alogliptin 25 mg QD · Regression, Logistic · p = 0.002 (No multiplicity adjustments.) · Odds ratio (or): 4.580 · 95% CI 1.740 to 12.052Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.

SecondaryNumber of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.

Time frame:: Baseline and Week 26.
Reported as:: Number · participants

Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.
participants	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.	0	11	11

SecondaryChange From Baseline in Body Weight (Week 8).

The change between Body Weight measured at week 8 and Body Weight measured at baseline.

Time frame:: Baseline and Week 8.
Reported as:: Least squares mean · kg

Change From Baseline in Body Weight (Week 8).
kg	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Body Weight (Week 8).	0.39 ± 0.191	0.10 ± 0.185	0.18 ± 0.189

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.291 (No multiplicity adjustments.) · Mean difference (final values): -0.28 · 95% CI -0.81 to 0.24Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.439 (No multiplicity adjustments.) · Mean difference (final values): -0.21 · 95% CI -0.74 to 0.32Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in Body Weight (Week 12).

The change between Body Weight measured at week 12 and Body Weight measured at baseline.

Time frame:: Baseline and Week 12.
Reported as:: Least squares mean · kg

Change From Baseline in Body Weight (Week 12).
kg	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Body Weight (Week 12).	0.50 ± 0.221	0.44 ± 0.215	0.31 ± 0.219

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.841 (No multiplicity adjustments.) · Mean difference (final values): -0.06 · 95% CI -0.67 to 0.55Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.556 (No multiplicity adjustments.) · Mean difference (final values): -0.18 · 95% CI -0.80 to 0.43Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in Body Weight (Week 20).

The change between Body Weight measured at week 20 and Body Weight measured at baseline.

Time frame:: Baseline and Week 20.
Reported as:: Least squares mean · kg

Change From Baseline in Body Weight (Week 20).
kg	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Body Weight (Week 20).	0.73 ± 0.231	0.55 ± 0.225	0.45 ± 0.229

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.586 (No multiplicity adjustments.) · Mean difference (final values): -0.18 · 95% CI -0.81 to 0.46Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.404 (No multiplicity adjustments.) · Mean difference (final values): -0.27 · 95% CI -0.91 to 0.37Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

SecondaryChange From Baseline in Body Weight (Week 26).

The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.

Time frame:: Baseline and Week 26.
Reported as:: Least squares mean · kg

Change From Baseline in Body Weight (Week 26).
kg	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Change From Baseline in Body Weight (Week 26).	0.63 ± 0.244	0.68 ± 0.237	0.60 ± 0.241

Statistical analysis

Placebo vs Alogliptin 12.5 mg QD · ANCOVA · p = 0.874 (No multiplicity adjustments.) · Mean difference (final values): 0.05 · 95% CI -0.62 to 0.72Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.
Placebo vs Alogliptin 25 mg QD · ANCOVA · p = 0.948 (No multiplicity adjustments.) · Mean difference (final values): -0.02 · 95% CI -0.70 to 0.65Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious event) after the last dose of double-blind drug.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	6/129 (4.7%)	54/129 (41.9%)
Alogliptin 12.5 mg QD	—	8/131 (6.1%)	58/131 (44.3%)
Alogliptin 25 mg QD	—	7/129 (5.4%)	50/129 (38.8%)

Most frequent serious events

Showing 10 of 19

Most frequent serious events
Event	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Atrial fibrillationCardiac disorders	0/129	2/131	0/129
CholecystitisHepatobiliary disorders	0/129	2/131	0/129
Angina unstableCardiac disorders	1/129	0/131	1/129
ArthralgiaMusculoskeletal and connective tissue disorders	0/129	0/131	1/129
Cervix carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/129	0/131	0/129
DemyelinationNervous system disorders	1/129	0/131	0/129
Diverticulitis intestinal haemorrhagicGastrointestinal disorders	1/129	0/131	0/129
HypersensitivityImmune system disorders	0/129	0/131	1/129
Hypoglycaemic comaNervous system disorders	0/129	0/131	1/129
Incisional herniaInjury, poisoning and procedural complications	1/129	0/131	0/129

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD
Urinary tract infectionInfections and infestations	10/129	8/131	9/129
ArthralgiaMusculoskeletal and connective tissue disorders	3/129	9/131	3/129
DiarrhoeaGastrointestinal disorders	7/129	1/131	8/129
NasopharyngitisInfections and infestations	6/129	5/131	8/129
Oedema peripheralGeneral disorders	4/129	4/131	7/129
HeadacheNervous system disorders	6/129	7/131	4/129
Abdominal painGastrointestinal disorders	1/129	1/131	6/129
Back painMusculoskeletal and connective tissue disorders	2/129	2/131	6/129
HypertensionVascular disorders	6/129	5/131	2/129
NauseaGastrointestinal disorders	3/129	4/131	6/129

Baseline characteristics

Age, Customized
Age, Customized(participants)	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Total
<65 years	109	112	106	327
≥65 years	21	19	23	63

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Alogliptin 12.5 mg QD	Alogliptin 25 mg QD	Total
Female	68	76	85	229
Male	62	55	44	161

Study locations

60 sites

Phoenix, Arizona, United States
Anaheim, California, United States
Artesia, California, United States
Fresno, California, United States
Mission Viejo, California, United States
Northridge, California, United States
Orange, California, United States
San Diego, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Denver, Colorado, United States
Cocoa Beach, Florida, United States
Longwood, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
St. Cloud, Florida, United States
Tampa, Florida, United States
Lawrenceville, Georgia, United States
Honolulu, Hawaii, United States
Avon, Indiana, United States
Evansville, Indiana, United States
Lafayette, Indiana, United States
St. Louis, Missouri, United States
Omaha, Nebraska, United States
Berlin, New Jersey, United States
Burlington, North Carolina, United States
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
Morehead City, North Carolina, United States
Pinehurst, North Carolina, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Lansdale, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Simpsonville, South Carolina, United States
Cookeville, Tennessee, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Texarkana, Texas, United States
Burlington, Vermont, United States
Multiple Cities, Argentina
Multiple Cities, Australia
Multiple Cities, Brazil
Multiple Cities, Chile
Multiple Cities, Czech Republic
Multiple Cities, Germany
Multiple Cities, Guatemala
Multiple Cities, Hungary
Multiple Cities, India
Multiple Cities, Mexico
Multiple Cities, Netherlands
Multiple Cities, New Zealand
Multiple Cities, Peru
Multiple Cities, Poland
Multiple Cities, South Africa

References and documents

Publications

Rosenstock J, Rendell MS, Gross JL, Fleck PR, Wilson CA, Mekki Q. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA(1C) without causing weight gain or increased hypoglycaemia. Diabetes Obes Metab. 2009 Dec;11(12):1145-52. doi: 10.1111/j.1463-1326.2009.01124.x. Epub 2009 Sep 16. PubMed 19758359 ↗
Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30. PubMed 19793357 ↗

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: NCT00286429
Lead sponsor: Takeda
Responsible party: Sponsor
First posted: Feb 3, 2006
Start date: Feb 2006
Primary completion: May 2007
Completion: May 2007
Results posted: Aug 12, 2011
Last update: Feb 3, 2012

Study contacts

VP Biological Sciences

study director · Takeda

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

Study summary

Conditions studied

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In context

Diabetes Mellitus

Lead sponsor

Who can participate

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Study design

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Interventions

What researchers measure

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Results

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Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

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Oversight

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Discussion

Other studies in this condition

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Inclusion criteria

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