Phase 3
Completed N=230
Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
Source: ClinicalTrials.gov NCT01263483 ↗Enrolled (actual)
230
Serious AEs
4.4%
Results posted
Jul 2011
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (Week 12). — 0.04; -0.96; -0.91 percentage of Glycosylated Hemoglobin
Summary
The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an α-glucosidase inhibitor taken 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). |
0.04; -0.96; -0.91 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 2). |
-0.01; -0.19; -0.21 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 4). |
-0.02; -0.44; -0.43 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 8). |
-0.01; -0.74; -0.75 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 2). |
-3.5; -15.5; -18.8 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 4). |
-0.6; -16.2; -22.6 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 8). |
-2.5; -20.8; -21.9 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 12). |
-5.6; -19.1; -18.5 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 2). |
0.03; -0.07; -0.01 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 4). |
0.05; 0.06; 0.01 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 8). |
0.07; 0.03; -0.01 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 12). |
0.02; 0.06; 0.10 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value). |
72.4; 40.9; 38.7 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)). |
-4.3; -74.7; -76.8 | — |
| SECONDARY Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2). |
-2.47; 4.62; 1.50 | — |
| SECONDARY Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). |
0.14; 0.69; 0.57 | — |
| SECONDARY Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). |
-0.4; -19.2; -20.5 | — |
Eligibility Criteria
Inclusion Criteria
- Had been receiving a stable dose and regimen of an α-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (Week -8) and during the screening phase.
- Had a glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (Week -4).
- Had HbA1c differences within 10.0% at the start of the screening phase (Week -8) and 4 weeks after the start of the screening phase (Week -4) from the HbA1c value at the start of the screening phase.
- Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of the screening phase (Week -8).
Exclusion Criteria
- Had received any antidiabetic drug other than α-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (Week -8) or during the screening phase.
Data sourced from ClinicalTrials.gov (NCT01263483). 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.