Phase 3
Completed N=288
Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan
Source: ClinicalTrials.gov NCT01318109 ↗Enrolled (actual)
288
Serious AEs
0.7%
Results posted
Jul 2011
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (Week 12). — -0.54; -0.64; 0.21 percentage of Glycosylated Hemoglobin
Summary
The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (Week 12). |
-0.54; -0.64; 0.21 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 2). |
-0.13; -0.13; 0.06 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 4). |
-0.29; -0.31; 0.09 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 8). |
-0.49; -0.56; 0.13 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 2). |
-19.2; -23.2; 0.0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 4). |
-19.8; -23.5; -2.2 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 8). |
-22.0; -21.3; -3.1 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 12). |
-19.0; -23.1; -0.8 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). |
61.7; 64.2; 70.6 | — |
Eligibility Criteria
Inclusion Criteria
- Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
- Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
- Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
- Was receiving specific diet and exercise (if any) therapies during the observation period.
Exclusion Criteria
- Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
- With a history or symptoms of lactic acidosis.
Data sourced from ClinicalTrials.gov (NCT01318109). 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.