Phase 2
Completed N=480
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan
Source: ClinicalTrials.gov NCT01263470 ↗Enrolled (actual)
480
Serious AEs
2.1%
Results posted
Jul 2011
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (Week 12). — 0.06; -0.51; -0.70; -0.76 percentage of Glycosylated Hemoglobin
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (Week 12). |
0.06; -0.51; -0.70; -0.76; -0.82; -0.16 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 2). |
0.00; -0.16; -0.17; -0.16; -0.15; -0.10 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 4). |
-0.01; -0.34; -0.38; -0.35; -0.40; -0.16 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 8). |
0.00; -0.50; -0.61; -0.66; -0.69; -0.17 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 2). |
1.8; -13.8; -15.9; -14.3; -21.7; -8.0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 4). |
8.4; -16.0; -20.9; -19.0; -23.3; -7.2 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 8). |
5.7; -12.0; -18.5; -18.6; -22.6; -3.5 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 12). |
5.6; -9.3; -14.6; -17.5; -22.6; -3.0 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 2). |
0.04; -0.11; 0.17; 0.18; 0.04; -0.11 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 4). |
0.01; -0.04; 0.02; 0.16; 0.05; -0.16 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 8). |
0.17; 0.05; 0.07; 0.24; 0.05; -0.05 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 12). |
-0.00; 0.04; 0.17; 0.25; 0.18; -0.02 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value). |
-4.2; -28.1; -27.6; -44.8; -47.0; -22.7 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)). |
5.6; -52.7; -55.0; -73.1; -81.8; -50.0 | — |
| SECONDARY Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)). |
-3.60; -0.74; 1.86; 4.12; -1.04; -15.40 | — |
| SECONDARY Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). |
0.01; 0.54; 0.77; 1.01; 0.97; -0.39 | — |
| SECONDARY Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). |
-15.8; -11.5; -4.5; -12.6; -19.5; -16.3 | — |
Eligibility Criteria
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
- Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.
Data sourced from ClinicalTrials.gov (NCT01263470). 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.