Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00885378
First received: April 21, 2009
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Saxagliptin plus metformin IR
Drug: Placebo plus metformin IR
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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination With Metformin IR in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Mean change was adjusted for baseline.


Secondary Outcome Measures:
  • Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Mean change was adjusted for baseline.

  • Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)

  • Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)


Enrollment: 166
Study Start Date: May 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saxagliptin plus metformin IR Drug: Saxagliptin plus metformin IR
Tablets, Oral, 2.5 mg, Twice daily, 12 weeks
Other Names:
  • BMS-477118
  • Onglyza
Placebo Comparator: Placebo plus metformin IR Drug: Placebo plus metformin IR
Tablets, Oral, Placebo, Twice daily, 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • 18-78 years of age
  • Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
  • A1C: 7-10%
  • C-peptide: ≥ 0.8 ng/mL
  • Body mass index (BMI): ≤45 kg/m^2

Exclusion Criteria:

  • Women of childbearing potential unable or unwilling to use acceptable birth control
  • Women who are pregnant or breastfeeding
  • Fasting plasma glucose (FPG) >270 mg/dL
  • Significant cardiovascular history
  • Symptoms of poorly controlled diabetes
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • Insulin therapy within one year of screening
  • Cardiovascular even within the prior 6 months
  • New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction <=40%
  • Significant history of renal or hepatic disease
  • History of a psychiatric disorder, alcohol or drug abuse within the previous year
  • Treatment with potent CYP3A4 inhibitors or inducers
  • Immunocompromised participants
  • Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885378

  Show 41 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00885378     History of Changes
Other Study ID Numbers: CV181-080, EUDRACT #: 2009-010224-25
Study First Received: April 21, 2009
Results First Received: November 2, 2011
Last Updated: December 22, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Hungary: Medical Research Council Ethic Committee for Clinical Pharmacology (MRC-ECCP)
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
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 15, 2014