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
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