Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Alogliptin and Metformin hydrochloride

• Registration Number: NCT03555565
• Lead Sponsor: Takeda

Brief Summary

The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.

Detailed Description

The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more).

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600.

This multi-center observational trial will be conducted in Japan.

Study Timeline

• Study Start: 2017-02-28
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-13
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Results First Submitted: 2020-10-29
• Results First Submitted QC: 2020-10-29
• Results First Posted: 2020-11-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1026

Inclusion Criteria

• Participants should meet one or more of the following:

  1. Have renal impairment (mild)
  2. Have hepatic impairment (mild or moderate)
  3. Elderly (aged 65 years or more)

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Exclusion Criteria

• Participants with any contraindication for study drug.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alogliptin and Metformin hydrochloride	Alogliptin and Metformin hydrochloride	Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received 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 12 months	An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin (HbA1c)	Baseline, up to final assessment point (up to Month 12)	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 12) relative to baseline.
Change From Baseline in Fasting Blood Glucose	Baseline, up to final assessment point (up to Month 12)	The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline.
Change From Baseline in Fasting Insulin Level	Baseline, up to final assessment point (up to Month 12)	The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.

Trial Locations

Locations (1)

Takeda Selected Site; 🇯🇵 Tokyo, Japan