Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Alogliptin

• Registration Number: NCT01964963
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Detailed Description

This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.

Study Timeline

• Study Start: 2011-08-03
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-17
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Results First Submitted: 2018-07-27
• Results First Submitted QC: 2019-02-07
• Results First Posted: 2019-05-09
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-12
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19192

Inclusion Criteria

-Patients with Haemoglobin A1c (HbA1c) [Japan Diabetes Society (JDS) value] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.

Exclusion Criteria

-Patients contraindicated for alogliptin.

1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
3. Patients with a history of hypersensitivity to any ingredient of alogliptin.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alogliptin	Alogliptin	Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Had One or More Adverse Events	Up to Month 36
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, and final assessment point (up to Month 36)	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 36) relative to baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Blood Glucose	Baseline, and final assessment point (up to Month 36)	The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline.