Alogliptin/Pioglitazone (Liovel) Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus

The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride

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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

Someplace, Japan

About this study

This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000.

The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with type 2 diabetes mellitus

Exclusion criteria

Patients meeting any of the following criteria will be excluded:

Patients with current cardiac failure or a past history of cardiac failure
Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
Patients with serious hepatic dysfunction
Patients with serious renal dysfunction
Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury
Patients with a history of hypersensitivity to any ingredients of Alogliptin/Pioglitazone
Pregnant or possibly pregnant women

Treatment and study plan

Alogliptin/Pioglitazone

Drug

Alogliptin/Pioglitazone combination tablets

Other names: Liovel、SYR-322-4833

Primary outcomes

Number of Participants Who Experience at Least One Adverse Events

Time frame: Up to 12 Months
Changes From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)

Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).

Secondary outcomes

Changes From Baseline in Fasting Blood Glucose (FBG)

Time frame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)

Reported data are changes in fasting blood glucose level from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Long-term Use of Alogliptin/Pioglitazone Combination Tablets in Patients With Type 2 Diabetes Mellitus

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Nov 21, 2013
Registry last updated: Sep 18, 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