Phase 3
Completed N=179
Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
Source: ClinicalTrials.gov NCT01263509 ↗Enrolled (actual)
179
Serious AEs
6.1%
Results posted
Aug 2011
Primary outcomePrimary: Number of Participants With Adverse Events. — 6; 7; 0; 1 participants
Summary
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events. |
6; 7; 0; 1; 85; 73 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 8). |
-0.69; -0.79 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 12). |
-0.89; -0.96 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 16). |
-0.91; -0.96 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 20). |
-0.90; -0.89 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 24). |
-0.83; -0.88 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 28). |
-0.81; -0.89 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 32). |
-0.80; -0.85 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 36). |
-0.82; -0.90 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 40). |
-0.78; -0.92 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 44). |
-0.88; -0.94 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 48). |
-0.92; -0.94 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 52). |
-0.95; -0.95 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Final Visit). |
-0.81; -0.89 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 8). |
-18.2; -20.4 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 12). |
-17.1; -18.8 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 16). |
-16.0; -15.3 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 20). |
-15.6; -15.0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 24). |
-13.8; -15.6 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 28). |
-14.5; -21.9 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 32). |
-17.7; -20.1 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 36). |
-17.3; -22.6 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 40). |
-19.7; -22.8 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 44). |
-21.5; -24.4 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 48). |
-20.5; -23.1 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 52). |
-20.7; -24.0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Final Visit). |
-17.5; -23.3 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 8). |
0.05; 0.11 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 12). |
0.10; 0.13 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 16). |
0.24; 0.21 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 20). |
0.24; 0.15 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 24). |
0.19; 0.14 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 28). |
0.18; 0.25 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 32). |
0.47; 0.31 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 36). |
0.33; 0.38 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 40). |
0.30; 0.37 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 44). |
0.08; 0.25 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 48). |
0.45; 0.38 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 52). |
0.80; 0.40 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Final Visit). |
0.31; 0.29 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). |
41.2; 37.6 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). |
38.0; 37.1 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). |
39.0; 40.8 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). |
39.6; 39.4 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). |
-73.2; -76.8 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). |
-69.0; -70.4 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). |
-83.5; -83.4 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). |
-77.5; -82.2 | — |
| SECONDARY Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). |
3.05; 2.95 | — |
| SECONDARY Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). |
4.42; 2.26 | — |
| SECONDARY Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). |
-1.28; 0.18 | — |
| SECONDARY Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). |
-0.61; 0.01 | — |
| SECONDARY Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). |
0.71; 0.71 | — |
| SECONDARY Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). |
1.38; 1.12 | — |
| SECONDARY Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). |
0.96; 2.18 | — |
| SECONDARY Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). |
1.05; 0.80 | — |
| SECONDARY Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). |
-14.3; -20.0 | — |
| SECONDARY Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). |
-4.6; -6.8 | — |
| SECONDARY Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). |
-12.0; -22.2 | — |
| SECONDARY Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). |
-11.7; -20.9 | — |
Eligibility Criteria
Inclusion Criteria
- Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
Exclusion Criteria
- Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
- Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Data sourced from ClinicalTrials.gov (NCT01263509). 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.