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

Long-term Use of Alogliptin/Pioglitazone Combination Tablets 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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Alogliptin/Pioglitazone

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 3281

Contacts and Locations

Study Locations

• Japan
  • Someplace, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes mellitus who have been examined at a medical institution

Description

Inclusion Criteria:

• Patients with type 2 diabetes mellitus

Exclusion Criteria:

• Patients meeting any of the following criteria will be excluded:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alogliptin/Pioglitazone combination tablets; Alogliptin/Pioglitazone combination tablets, taken orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.	Drug: Alogliptin/Pioglitazone; Alogliptin/Pioglitazone combination tablets; Other Names: Liovel、SYR-322-4833

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience at Least One Adverse Events		Up to 12 Months
Changes From Baseline in Glycosylated Hemoglobin (HbA1c)	Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).	Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes From Baseline in Fasting Blood Glucose (FBG)	Reported data are changes in fasting blood glucose level from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).	Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2011
• Primary Completion (Actual): March 31, 2015
• Study Completion (Actual): March 31, 2015

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimated): November 21, 2013

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Pioglitazone; Alogliptin
• Other Study ID Numbers: 136-011; JapicCTI-132302 (Registry Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No