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"

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants should meet one or more of the following:

Have renal impairment (mild)
Have hepatic impairment (mild or moderate)
Elderly (aged 65 years or more)

Exclusion criteria

Participants with any contraindication for study drug.

Treatment and study plan

Alogliptin and Metformin hydrochloride

Drug

Alogliptin and Metformin hydrochloride combination tablets

Other names: Inisync combination tablets

Primary outcomes

Percentage of Participants Who Had One or More Adverse Events

Time frame: 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 outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Jun 13, 2018
Registry last updated: Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed