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"

Takeda1,026 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,026

Conditions

Type 2 Diabetes Mellitus

Interventions

Alogliptin and Metformin hydrochlorideDRUG

Alogliptin and Metformin hydrochloride combination tablets

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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) Exclusion Criteria: * Participants with any contraindication for study drug.

Locations (1)

Takeda Selected Site

Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of Participants Who Had One or More Adverse Events

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.

Time frame: Up to 12 months

Secondary Outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

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.

Time frame: Baseline, up to final assessment point (up to Month 12)

Change From Baseline in Fasting Blood Glucose

The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline.

Time frame: Baseline, up to final assessment point (up to Month 12)

Change From Baseline in Fasting Insulin Level

The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.

Time frame: Baseline, up to final assessment point (up to Month 12)

Data from ClinicalTrials.gov

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