Clinical trial NCT01263470: Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 in Subjects With Type 2 Diabetes in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus - Type 2
Diabetes Mellitus
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-12-20
Enrollment: 480
Sex: ALL
Minimum age (years): 20
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 dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.

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.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.

Eligibility criteria: Inclusion Criteria:

* A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
* A HbA1c differences within 10.0%\* (\*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
* Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Exclusion Criteria:

* Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.

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 Fasting C-peptide (Week 2).
timeFrame: Baseline and Week 2.
measure: Change From Baseline in Fasting C-peptide (Week 4).
timeFrame: Baseline and Week 4.
measure: Change From Baseline in Fasting C-peptide (Week 8).
timeFrame: Baseline and Week 8.
measure: Change From Baseline in Fasting C-peptide (Week 12).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).
timeFrame: Baseline and Week 12
measure: Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).
timeFrame: Baseline and Week 12.
measure: Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Okayama
country: Japan
Study officials:
affiliation: Kawasaki Medical School
name: Professor, Department of Medicine
role: STUDY_DIRECTOR
References: