N/A
Completed N=1,101
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
Surveillance
Source: ClinicalTrials.gov NCT01964950 ↗
Enrolled (actual)
1,101
Serious AEs
0.5%
Results posted
Apr 2017
Primary outcomePrimary: Number of Participants Reporting One or More Adverse Drug Reactions — 19; 1 participants
Summary
The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea 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 |
19; 1 | — |
| PRIMARY Number of Participants Reporting One or More Serious Adverse Drug Reaction |
5; 0 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
8.03; -0.40; -0.66; -0.72; -0.64; -0.65 | — |
| SECONDARY Percentage of Participants Achieving Objective Glycemic Control |
56.3; 75.4; 19.3; 43.0; 1.7; 4.6 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
151.1; -14.6; -13.8; -13.1; -16.4; -13.7 | — |
| SECONDARY Change From Baseline in Fasting Insulin Level |
7.88; 1.27; 0.21; 0.69; 1.17; 1.86 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who did not adequately respond to the following treatment • Treatment with sulfonylurea in addition to diet therapy and exercise therapy
Exclusion Criteria
- Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate).
- Participants with severe infection, pre- or post-operative participants, or participants with serious traumatic injury (blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate).
- Participants with a history of hypersensitivity to any ingredient of Nesina.
Data sourced from ClinicalTrials.gov (NCT01964950). 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.