Phase 3
Completed N=326
Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
Source: ClinicalTrials.gov NCT01318122 ↗Enrolled (actual)
326
Serious AEs
7.6%
Results posted
Sep 2011
Primary outcomePrimary: Number of Participants With Adverse Events. — 14; 11; 143; 146 participants
Summary
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events. |
14; 11; 143; 146 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 8). |
-0.68; -0.73 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 12). |
-0.81; -0.88 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 16). |
-0.86; -0.92 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 20). |
-0.84; -0.90 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 24). |
-0.78; -0.82 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 28). |
-0.75; -0.76 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 32). |
-0.72; -0.72 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 36). |
-0.67; -0.69 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 40). |
-0.65; -0.66 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 44). |
-0.70; -0.74 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 48). |
-0.73; -0.76 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Week 52). |
-0.77; -0.79 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (Final Visit). |
-0.65; -0.65 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 8). |
-15.5; -18.1 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 12). |
-13.4; -16.3 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 16). |
-11.9; -13.4 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 20). |
-10.1; -13.9 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 24). |
-10.0; -10.7 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 28). |
-5.6; -9.1 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 32). |
-7.9; -10.4 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 36). |
-7.1; -11.9 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 40). |
-9.5; -10.6 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 44). |
-10.4; -10.4 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 48). |
-12.2; -14.0 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Week 52). |
-12.8; -13.6 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (Final Visit). |
-11.4; -11.1 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). |
58.3; 49.5 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24). |
55.9; 47.9 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52). |
59.1; 57.2 | — |
| SECONDARY Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit). |
59.8; 56.8 | — |
Eligibility Criteria
Inclusion Criteria
- Had completed the core phase 2/3 thiazolidine add on study.
- The subject was capable of understanding and complying with protocol requirements.
- Signed a written, informed consent form prior to the initiation of any study procedure.
Exclusion Criteria
- With clinical manifestation of hepatic impairment (e.g., an AST or ALT value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 thiazolidine add on study).
- With clinical manifestation of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of the core phase 2/3 thiazolidine add on study).
- With a history or symptoms of cardiac failure.
Data sourced from ClinicalTrials.gov (NCT01318122). 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.