A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Official Title: “A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control”

The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitazone (rescue medication) added onto their blinded study medication

Intervention(s) in this Clinical Trial

• Drug: Saxagliptin
  • Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT)
• Drug: Saxagliptin
  • Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT)
• Drug: Metformin
  • Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT)
• Drug: Placebo
  • Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT)
• Drug: pioglitazone
  • Tablets, Oral, 15-45 mg, as needed (12 months LT)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Saxagliptin and Metformin (A)
  • PLUS open-label pioglitazone (as needed as rescue medication)
• Experimental: Saxagliptin and Metformin (B)
  • PLUS open-label pioglitazone (as needed as rescue medication)
• Experimental: Saxagliptin and Placebo (C)
  • PLUS open-label pioglitazone (as needed as rescue medication)
• Active Comparator: Metformin and Placebo (D)
  • PLUS open-label pioglitazone (as needed as rescue medication)

Primary Measures

• Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
  • Time Frame: Baseline, Week 24
    Safety Issue?: No
• Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
  • Time Frame: Baseline, Week 24
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
  • Time Frame: Baseline, Week 24
    Safety Issue?: No
• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
  • Time Frame: Baseline, Week 24
    Safety Issue?: No
• Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
  • Time Frame: Week 24
    Safety Issue?: No
• Percentage of Participants Achieving A1C < 7% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
  • Time Frame: Week 24
    Safety Issue?: No
• Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
  • Time Frame: Baseline, Week 24
    Safety Issue?: No
• Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
  • Time Frame: Baseline, Week 24
    Safety Issue?: No
• Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
  • Time Frame: Week 24
    Safety Issue?: No
• Percentage of Participants Achieving A1C ≤6.5% at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
  • Time Frame: Week 24
    Safety Issue?: No
• Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy
  • Time Frame: Week 24
    Safety Issue?: No
• Percentage of Participants Requiring Rescue or Discontinuation at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy
  • Time Frame: Week 24
    Safety Issue?: No

Inclusion Criteria:

• Type 2 diabetes
• Inadequate blood sugar control
• No current treatment with other medications to lower blood sugar

Exclusion Criteria:

• Major heart, liver or kidney problems
• Pregnant or breast feeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 77 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bristol-Myers Squibb Industry

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00327015

Study ID Number: CV181-039

ClinicalTrials.gov Identifier: NCT00327015

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm