Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01263483
First received: December 17, 2010
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 an α-glucosidase inhibitor taken three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Alogliptin and voglibose
Drug: Voglibose
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 α-glucosidase Inhibitor 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 (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 (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 at 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 at 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 at 2 hours after the start of the meal.


Enrollment: 230
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Voglibose 0.2 mg TID Drug: Voglibose
Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Other Names:
  • BASEN®
  • Voglibose
Experimental: Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID Drug: Alogliptin and voglibose
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Other Names:
  • SYR-322
  • BASEN®
  • Voglibose
Experimental: Alogliptin 25 mg QD and Voglibose 0.2 mg TID Drug: Alogliptin and voglibose
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Other Names:
  • SYR-322
  • BASEN®
  • Voglibose

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.

In Japan, α-glucosidase inhibitors are widely used as a first-line treatment for type 2 diabetes mellitus. Because alogliptin has a different mechanism of action compared to α-glucosidase inhibitors, the study evaluated the efficacy and safety of alogliptin combined with an α-glucosidase inhibitor in type 2 diabetic patients with uncontrolled blood glucose while taking a α-glucosidase inhibitor and receiving diet and/or exercise therapies.

To evaluate the long-term safety and efficacy of the concomitant use of alogliptin and an α-glucosidase inhibitor, subjects who participated in the present study could enter a long-term extension study SYR-322/OCT-003 (NCT01263509) that was planned separately.

  Eligibility

Ages Eligible for Study:   33 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Had been receiving a stable dose and regimen of an α-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (Week -8) and during the screening phase.
  • Had a glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (Week -4).
  • Had HbA1c differences within 10.0% at the start of the screening phase (Week -8) and 4 weeks after the start of the screening phase (Week -4) from the HbA1c value at the start of the screening phase.
  • Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of the screening phase (Week -8).

Exclusion Criteria:

  • Had received any antidiabetic drug other than α-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (Week -8) or during the screening phase.
  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: NCT01263483

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: NCT01263483     History of Changes
Other Study ID Numbers: SYR-322/CCT-003, U1111-1118-3955, JapicCTI-080589
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, Type 2
Diabetes Mellitus
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 22, 2014