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:
Bristol-Myers Squibb
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
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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:
|
| 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
Show 41 Study LocationsSponsors 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 May 19, 2013