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Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Alogliptin and pioglitazone (Drug); Alogliptin and pioglitazone (Drug); Pioglitazone (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Professor, Diabetes and Endocrine Division, Department of Medicine, Study Director, Affiliation: Kawasaki Medical School

Summary

The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose.

Clinical Details

Official title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Thiazolidine in Subjects With Type 2 Diabetes in Japan

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (Week 12).

Secondary outcome:

Change From Baseline in Glycosylated Hemoglobin (Week 2).

Change From Baseline in Glycosylated Hemoglobin (Week 4).

Change From Baseline in Glycosylated Hemoglobin (Week 8).

Change From Baseline in Fasting Plasma Glucose (Week 2).

Change From Baseline in Fasting Plasma Glucose (Week 4).

Change From Baseline in Fasting Plasma Glucose (Week 8).

Change From Baseline in Fasting Plasma Glucose (Week 12).

Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).

Detailed description: Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to pioglitazone in type 2 diabetic patients with uncontrolled blood glucose despite treatment with pioglitazone as well as diet and exercise therapies.

Eligibility

Minimum age: 33 Years. Maximum age: 88 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the start of the treatment period (Week 0). 2. Had glycosylated hemoglobin (HbA1c) of 6. 5% or more and below 10. 0% at 14 weeks after

the start of the observation period (Week - 2).

3. Had HbA1c difference within 10. 0%* at 10 weeks after the start of the observation

period (Week - 6) and 14 weeks after the start of the observation period (Week -2)

from 10 weeks after the start of the observation period (Week - 6) (*rounded off to

the first decimal place). 4. Was receiving specific diet and exercise (if any) therapies during the observation period. Exclusion Criteria: 1. Had taken a diabetic medications other than pioglitazone within 16 weeks before the start of the treatment period (Week 0). 2. Had a history or symptoms of cardiac failure.

Locations and Contacts

Additional Information

Starting date: November 2007
Last updated: February 1, 2012

Page last updated: August 23, 2015

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