N/A
Completed N=1,096
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
Surveillance
Source: ClinicalTrials.gov NCT01964976 ↗
Enrolled (actual)
1,096
Serious AEs
0.4%
Results posted
Apr 2017
Primary outcomePrimary: Number of Participants Reporting One or More Adverse Drug Reactions — 26; 2 participants
Summary
To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and biguanides in participants with type 2 diabetes mellitus who responded inadequately to treatment with biguanides 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 |
26; 2 | — |
| PRIMARY Number of Participants Reporting One or More Serious Adverse Drug Reactions |
4; 0 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
7.84; -0.35; -0.59; -0.62; -0.65; -0.58 | — |
| SECONDARY Percentage of Participants of Achieving Objective Glycemic Control |
62.8; 80.5; 21.4; 47.2; 1.4; 5.2 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
151.8; -16.7; -17.1; -16.0; -19.1; -17.2 | — |
| SECONDARY Change From Baseline in Fasting Insulin Level |
9.00; 1.79; 2.21; 0.04; -1.21; -0.25 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who did not adequately respond to the following treatment • Treatment with biguanides in addition to diet therapy and exercise therapy
Exclusion Criteria
- Participants contraindicated for Nesina
- 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 patients, or patients 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 (NCT01964976). 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.