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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01263470
First received: December 17, 2010
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Alogliptin
Drug: Voglibose
Drug: Placebo
Phase 2

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, 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

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 or final visit 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 fasting plasma glucose 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 fasting plasma glucose 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 fasting plasma glucose 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 fasting plasma glucose collected at baseline.

  • Change From Baseline in Fasting C-peptide (Week 2). [ Time Frame: Baseline and Week 2. ] [ Designated as safety issue: No ]
    The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.

  • Change From Baseline in Fasting C-peptide (Week 4). [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
    The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.

  • Change From Baseline in Fasting C-peptide (Week 8). [ Time Frame: Baseline and Week 8. ] [ Designated as safety issue: No ]
    The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.

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

  • Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)). [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 480
Study Start Date: January 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
Experimental: Alogliptin 6.25 mg QD Drug: Alogliptin
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Other Name: SYR-322
Experimental: Alogliptin 12.5 mg QD Drug: Alogliptin
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Other Name: SYR-322
Experimental: Alogliptin 25 mg QD Drug: Alogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Other Name: SYR-322
Experimental: Alogliptin 50 mg QD Drug: Alogliptin
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
Other Name: SYR-322
Active Comparator: Voglibose 0.2 mg TID Drug: Voglibose
Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Other Names:
  • Voglib
  • BASEN®

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263470

Locations
Japan
Okayama, Japan, 701-0192
Sponsors and Collaborators
Takeda
Investigators
Study Director: Professor, Department of Medicine Kawasaki Medical School
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01263470     History of Changes
Other Study ID Numbers: SYR-322/CCT-001, U1111-1118-3752
Study First Received: December 17, 2010
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 - Type 2
Diabetes Mellitus
Drug Therapy

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

ClinicalTrials.gov processed this record on September 18, 2014