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

February 1, 2012 updated by: Takeda

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 Sulfonylurea in Subjects With Type 2 Diabetes in Japan

The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 sulfonylurea in type 2 diabetic patients who had uncontrolled blood glucose despite treatment with an sulfonylurea as well as diet and exercise therapies.

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 2
  • Phase 3

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

20 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Had been taking a sulfonylurea for at least 4 weeks prior to the initiation of the observation period (Week -12).
  2. Had been taking glimepiride at a stable dose regimen (1, 2, 3 or 4 mg/day, once or twice daily in the morning or in the morning and evening, before or after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
  3. Had glycosylated hemoglobin (HbA1c) of 7.0% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
  4. Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
  5. Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

1. Had taken other diabetic medications than glimepiride within 12 weeks before the initiation of the treatment period (Week 0).

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Alogliptin 12.5 mg QD and Glimepiride QD or BID
Drug: Alogliptin and glimepiride
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Other Names:
  • Amaryl
  • SYR-322
Drug: Alogliptin and glimepiride
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Other Names:
  • Amaryl
  • SYR-322
ACTIVE_COMPARATOR: Alogliptin 25 mg QD and Glimepiride QD or BID
Drug: Alogliptin and glimepiride
Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Other Names:
  • Amaryl
  • SYR-322
Drug: Alogliptin and glimepiride
Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
Other Names:
  • Amaryl
  • SYR-322
ACTIVE_COMPARATOR: Glimepiride 1, 2, 3 or 4 mg QD or BID
Drug: Glimepiride
Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Other Names:
  • Amaryl

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 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 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 baseline.
Baseline and Week 4.
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 baseline.
Baseline and Week 8.
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 baseline.
Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
Time Frame: Baseline and Week 12.
The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 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

Takeda

Investigators

  • Study Director: Professor, Professor, Diabetes and Endocrine Division, Department of Medicine, Kawasaki Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2008

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 17, 2011

First Posted (ESTIMATE)

March 18, 2011

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

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYR-322/CCT-005
  • UMIN000001393 (REGISTRY: UMIN-CTR)
  • JapicCTI-080626 (REGISTRY: JapicCTI)
  • U1111-1119-6261 (REGISTRY: WHO)

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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