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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01318070
First received: March 16, 2011
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Alogliptin and pioglitazone
Drug: Pioglitazone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (Week 12). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]
    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 and glycosylated hemoglobin collected at baseline.


Secondary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (Week 2). [ Time Frame: Baseline and Week 2. ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Glycosylated Hemoglobin (Week 4). [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Glycosylated Hemoglobin (Week 8). [ Time Frame: Baseline and Week 8. ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Fasting Plasma Glucose (Week 2). [ Time Frame: Baseline and Week 2. ] [ Designated as safety issue: No ]
    The change between the value of fasting plasma glucose collected at week 2 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Fasting Plasma Glucose (Week 4). [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
    The change between the value of fasting plasma glucose collected at week 4 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Fasting Plasma Glucose (Week 8). [ Time Frame: Baseline and Week 8. ] [ Designated as safety issue: No ]
    The change between the value of fasting plasma glucose collected at week 8 and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Fasting Plasma Glucose (Week 12). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]
    The change between the value of fasting plasma glucose collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.

  • Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]
    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 2 hours after the start of the meal.


Enrollment: 339
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD Drug: Alogliptin and pioglitazone
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Other Names:
  • Alogliptin (SYR-322)
  • Pioglitazone: Actos®
Experimental: Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD Drug: Alogliptin and pioglitazone
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Other Names:
  • Alogliptin (SYR-322)
  • Pioglitazone: Actos®
Active Comparator: Pioglitazone (15mg or 30mg ) QD Drug: Pioglitazone
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Other Name: Pioglitazone: Actos®

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

Ages Eligible for Study:   33 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318070

Sponsors and Collaborators
Takeda
Investigators
Study Director: Professor, Diabetes and Endocrine Division, Department of Medicine Kawasaki Medical School
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01318070     History of Changes
Other Study ID Numbers: SYR-322/CCT-004, UMIN000001382, JapicCTI-080590, U1111-1118-4073
Study First Received: March 16, 2011
Results First Received: June 8, 2011
Last Updated: February 1, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Diabetes Mellitus - Type2
Diabetes Mellitus
Drug Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Alogliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014