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

February 1, 2012 updated by: Takeda

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Okayama, Japan, 701-0192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
Experimental: Alogliptin 12.5 mg QD
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Other Names:
  • SYR-322
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Other Names:
  • SYR-322
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Other Names:
  • SYR-322
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
Other Names:
  • SYR-322
Experimental: Alogliptin 25 mg QD
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Other Names:
  • SYR-322
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Other Names:
  • SYR-322
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Other Names:
  • SYR-322
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
Other Names:
  • SYR-322
Experimental: Alogliptin 50 mg QD
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Other Names:
  • SYR-322
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Other Names:
  • SYR-322
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Other Names:
  • SYR-322
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
Other Names:
  • SYR-322
Experimental: Alogliptin 6.25 mg QD
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Other Names:
  • SYR-322
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Other Names:
  • SYR-322
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Other Names:
  • SYR-322
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
Other Names:
  • SYR-322
Active Comparator: Voglibose 0.2 mg TID
Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Other Names:
  • BASEN®
  • Voglib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (Week 12).
Time Frame: Baseline and Week 12.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
Baseline and Week 12.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (Week 8).
Time Frame: Baseline and Week 8.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.
Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 8).
Time Frame: Baseline and Week 8.
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Baseline and Week 8.
Change From Baseline in Fasting C-peptide (Week 8).
Time Frame: Baseline and Week 8.
The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.
Baseline and Week 8.
Change From Baseline in Glycosylated Hemoglobin (Week 2).
Time Frame: Baseline and Week 2.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.
Baseline and Week 2.
Change From Baseline in Glycosylated Hemoglobin (Week 4).
Time Frame: Baseline and Week 4.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.
Baseline and Week 4.
Change From Baseline in Fasting Plasma Glucose (Week 2).
Time Frame: Baseline and Week 2
The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.
Baseline and Week 2
Change From Baseline in Fasting Plasma Glucose (Week 4).
Time Frame: Baseline and Week 4.
The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
Baseline and Week 4.
Change From Baseline in Fasting Plasma Glucose (Week 12).
Time Frame: Baseline and Week 12.
The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.
Baseline and Week 12.
Change From Baseline in Fasting C-peptide (Week 2).
Time Frame: Baseline and Week 2.
The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.
Baseline and Week 2.
Change From Baseline in Fasting C-peptide (Week 4).
Time Frame: Baseline and Week 4.
The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.
Baseline and Week 4.
Change From Baseline in Fasting C-peptide (Week 12).
Time Frame: Baseline and Week 12.
The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.
Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).
Time Frame: Baseline and Week 12.
The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).
Time Frame: Baseline and Week 12.
The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Baseline and Week 12.
Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).
Time Frame: Baseline and Week 12
The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Baseline and Week 12
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).
Time Frame: Baseline and Week 12.
The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Baseline and Week 12.
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).
Time Frame: Baseline and Week 12
The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Professor, Department of Medicine, Kawasaki Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 17, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (Estimate)

December 20, 2010

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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