Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

Completed

• Conditions: Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution
• Interventions: Drug: Alogliptin

• Registration Number: NCT01945216
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor.

In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.

Detailed Description

A special drug use surveillance is planned to examine the safety and efficacy of long-term use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use conditions.

Participants of this surveillance will be patients with type 2 diabetes mellitus who failed to respond adequately to diet therapy and exercise therapy alone or to a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. The planned sample size is 3,000 subjects.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily. Participants will receive the drug as part of routine medical care.

Study Timeline

• Study Start: 2010-07-08
• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-18
• Primary Completion: 2015-10-31
• Study Completion: 2015-10-31
• Results First Submitted: 2017-08-02
• Results First Submitted QC: 2018-11-05
• Results First Posted: 2018-11-08
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3317

Inclusion Criteria

• Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:

  1. Diet therapy and exercise therapy alone
  2. In addition to diet therapy and exercise therapy, use of α-glucosidase inhibitor

Exclusion Criteria

• Patients contraindicated for Nesina

  1. 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.)
  2. 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.)
  3. Patients with a history of hypersensitivity to any ingredient of Nesina

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alogliptin 25mg, tablets, orally, once daily, up to 36 months	Alogliptin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience at Least One Adverse Events	Up to Month 36
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (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 month 36 relative to baseline.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Blood Glucose	Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)	The change in the value of fasting blood glucose collected at month 36 relative to baseline.