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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Alogliptin/Pioglitazone

• Registration Number: NCT01990300
• Lead Sponsor: Takeda

Brief Summary

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

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 Timeline

• Study Start: 2011-11-28
• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-21
• Primary Completion: 2015-03-31
• Study Completion: 2015-03-31
• Results First Submitted: 2017-11-06
• Results First Submitted QC: 2018-08-09
• Results First Posted: 2019-01-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3281

Inclusion Criteria

• Patients with type 2 diabetes mellitus

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alogliptin/Pioglitazone combination tablets	Alogliptin/Pioglitazone	Alogliptin/Pioglitazone combination tablets, taken orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience at Least One Adverse Events	Up to 12 Months
Changes From Baseline in Glycosylated Hemoglobin (HbA1c)	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 Outcome Measures

Name	Time	Method
Changes From Baseline in Fasting Blood Glucose (FBG)	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).