Phase 2
Completed N=438
Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
Source: ClinicalTrials.gov NCT01263496 ↗Enrolled (actual)
438
Serious AEs
5.7%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants With Adverse Events. — 1; 5; 8; 5 participants
Summary
The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events. |
1; 5; 8; 5; 4; 1 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 12). |
-0.55; -0.70; -0.74; -0.86; -0.15 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 16). |
-0.57; -0.75; -0.77; -0.90; -0.25 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 20). |
-0.56; -0.69; -0.70; -0.88; -0.30 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 24). |
-0.47; -0.61; -0.66; -0.83; -0.29 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 28). |
-0.39; -0.56; -0.67; -0.78; -0.32 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 32). |
-0.35; -0.56; -0.61; -0.76; -0.27 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 36). |
-0.33; -0.52; -0.66; -0.77; -0.28 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 40). |
-0.33; -0.48; -0.66; -0.77; -0.28 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 44). |
-0.29; -0.59; -0.71; -0.79; -0.35 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 48). |
-0.43; -0.66; -0.76; -0.83; -0.40 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 52). |
-0.49; -0.65; -0.74; -0.85; -0.37 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Final Visit). |
-0.40; -0.47; -0.63; -0.86; -0.22 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 12). |
-12.1; -15.3; -17.0; -23.0; -3.6 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 16). |
-10.8; -15.8; -17.0; -18.8; -6.4 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 20). |
-11.5; -15.3; -13.8; -20.1; -4.6 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 24). |
-10.6; -11.7; -13.8; -20.2; -8.3 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 28). |
-9.6; -13.4; -14.1; -19.9; -7.2 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 32). |
-14.5; -12.9; -14.9; -20.3; -9.1 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 36). |
-10.7; -14.3; -16.9; -20.9; -8.4 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 40). |
-13.5; -14.8; -15.7; -23.2; -13.8 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 44). |
-16.7; -18.7; -19.0; -24.7; -15.0 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 48). |
-16.0; -20.8; -22.8; -25.4; -13.5 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Week 52). |
-13.7; -19.5; -21.4; -26.0; -12.5 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (Final Visit). |
-10.4; -15.5; -17.1; -27.6; -8.8 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 12). |
-0.02; 0.19; 0.19; 0.25; -0.04 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 16). |
0.08; 0.22; 0.33; 0.46; -0.01 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 20). |
0.15; 0.35; 0.28; 0.56; -0.16 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 24). |
0.12; 0.26; 0.20; 0.23; -0.10 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 28). |
0.11; 0.21; 0.26; 0.29; -0.04 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 32). |
0.03; 0.41; 0.45; 0.37; -0.01 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 36). |
0.12; 0.33; 0.20; 0.42; 0.09 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 40). |
-0.14; 0.48; 0.27; 0.44; 0.13 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 44). |
0.22; 0.52; 0.59; 0.20; -0.06 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 48). |
-0.40; 0.54; 0.04; 0.15; -0.10 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Week 52). |
-0.25; 0.73; 0.10; 0.30; 0.70 | — |
| SECONDARY Change From Baseline in Fasting C-peptide (Final Visit). |
0.34; 0.44; 0.32; 0.48; 0.18 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12). |
62.9; 61.8; 56.4; 55.8; 64.8 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24). |
64.3; 55.5; 55.5; 55.9; 56.6 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52). |
65.7; 62.6; 58.3; 51.8; 61.0 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit). |
65.0; 63.8; 60.4; 52.6; 52.6 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). |
-57.0; -55.4; -67.8; -80.5; -50.0 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). |
-43.9; -52.5; -69.8; -75.1; -62.4 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). |
-59.5; -62.0; -69.0; -88.7; -65.4 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). |
-53.5; -55.1; -67.6; -91.3; -56.4 | — |
| SECONDARY Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). |
0.56; 0.97; 0.96; 0.99; -0.39 | — |
| SECONDARY Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). |
0.93; 1.35; 1.14; 1.38; -0.10 | — |
| SECONDARY Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). |
1.91; 3.44; 2.37; 3.14; 1.86 | — |
| SECONDARY Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). |
0.99; 1.45; 1.14; 1.41; 0.15 | — |
| SECONDARY Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12). |
0.49; 2.63; 4.44; -0.03; -15.40 | — |
| SECONDARY Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24). |
-1.89; 4.50; 2.85; -0.98; -16.21 | — |
| SECONDARY Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52). |
-7.62; -1.71; -0.44; -2.30; -15.66 | — |
| SECONDARY Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit). |
-6.93; -1.67; 0.43; -1.56; -14.65 | — |
| SECONDARY Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12). |
-9.5; -4.4; -6.6; -15.5; -16.3 | — |
| SECONDARY Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24). |
-1.7; 3.0; 0.9; -0.8; -7.6 | — |
| SECONDARY Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52). |
-10.7; -11.3; -14.5; -12.5; -13.8 | — |
| SECONDARY Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit). |
-9.8; -9.0; -10.3; -14.6; -13.9 | — |
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 (NCT01263496). 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.