Phase 3
Completed N=339
Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
Source: ClinicalTrials.gov NCT01318070 ↗Enrolled (actual)
339
Serious AEs
2.4%
Results posted
Jul 2011
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (Week 12). — -0.91; -0.97; -0.19 percentage of Glycosylated Hemoglobin
Summary
The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (Week 12). |
-0.91; -0.97; -0.19 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 2). |
-0.22; -0.22; -0.04 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 4). |
-0.47; -0.46; -0.10 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 8). |
-0.76; -0.81; -0.17 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 2). |
-12.8; -17.0; -3.9 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 4). |
-14.4; -17.9; -3.1 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 8). |
-17.1; -21.3; -4.2 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 12). |
-14.9; -18.9; -2.4 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). |
58.3; 49.4; 70.6 | — |
Eligibility Criteria
Inclusion Criteria
- Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the start of the treatment period (Week 0).
- Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after the start of the observation period (Week -2).
- Had HbA1c difference within 10.0%* at 10 weeks after the start of the observation period (Week -6) and 14 weeks after the start of the observation period (Week -2) from 10 weeks after the start of the observation period (Week -6) (*rounded off to the first decimal place).
- Was receiving specific diet and exercise (if any) therapies during the observation period.
Exclusion Criteria
- Had taken a diabetic medications other than pioglitazone within 16 weeks before the start of the treatment period (Week 0).
- Had a history or symptoms of cardiac failure.
Data sourced from ClinicalTrials.gov (NCT01318070). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.