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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990300
• Other study ID #: 136-011
• Secondary ID: JapicCTI-132302
• Status: Completed
• Start date: November 28, 2011
• Est. completion date: March 31, 2015

Study information

• Verified date: August 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3281
• Est. completion date: March 31, 2015
• Est. primary completion date: March 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Alogliptin/Pioglitazone
Alogliptin/Pioglitazone combination tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experience at Least One Adverse Events		Up to 12 Months
Primary	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	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)