Clinical trial NCT01318070: Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type2
Diabetes Mellitus
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 339
Sex: ALL
Minimum age (years): 33
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (Week 12).
timeFrame: Baseline and Week 12.
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (Week 2).
timeFrame: Baseline and Week 2.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 4).
timeFrame: Baseline and Week 4.
measure: Change From Baseline in Glycosylated Hemoglobin (Week 8).
timeFrame: Baseline and Week 8.
measure: Change From Baseline in Fasting Plasma Glucose (Week 2).
timeFrame: Baseline and Week 2.
measure: Change From Baseline in Fasting Plasma Glucose (Week 4).
timeFrame: Baseline and Week 4.
measure: Change From Baseline in Fasting Plasma Glucose (Week 8).
timeFrame: Baseline and Week 8.
measure: Change From Baseline in Fasting Plasma Glucose (Week 12).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
timeFrame: Baseline and Week 12.
Other outcomes:
Locations:
Study officials:
affiliation: Kawasaki Medical School
name: Professor, Diabetes and Endocrine Division, Department of Medicine
role: STUDY_DIRECTOR
References: