N/A
Completed N=1,374
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"
Type 2 Diabetes Melitus
Source: ClinicalTrials.gov NCT01945242 ↗
Enrolled (actual)
1,374
Serious AEs
0.2%
Results posted
Sep 2016
Primary outcomePrimary: Number of Participants Reporting One or More Adverse Drug Reactions — 1; 0; 1; 0 participants
Summary
The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Adverse Drug Reactions |
1; 0; 1; 0; 5; 1 | — |
| PRIMARY Number of Participants Reporting One or More Serious Adverse Drug Reactions |
1; 0; 2; 0 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
7.67; -0.25; -0.47; -0.53; -0.64; -0.57 | — |
| SECONDARY Percentage of Participants of Achieving Objective Glycemic Control |
68.0; 75.8; 84.2; 84.5; 87.1; 83.6 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
145.4; -9.8; -11.8; -13.9; -16.2; -13.5 | — |
| SECONDARY Change From Baseline in Fasting Insulin |
6.32; 0.19; -0.02; 0.29; -0.32; -0.25 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who did not adequately respond to the following treatment • Treatment with thiazolidinediones in addition to diet therapy and exercise therapy
Exclusion Criteria
- Patients contraindicated for Nesina
- Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.)
- Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.)
- Patients with a history of hypersensitivity to any ingredient of Nesina
Data sourced from ClinicalTrials.gov (NCT01945242). 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.