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

Overview

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.

Full Title of Study: “Alogliptin (Nesina) Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 31, 2017

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.

Interventions

  • Drug: Alogliptin
    • Alogliptin tablets

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Who Had One or More Adverse Events
    • Time Frame: Up to Month 36
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c)
    • Time Frame: 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 Measures

  • Change From Baseline in Fasting Blood Glucose
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda

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