Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone

Official Title: “"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone"”

The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with 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 pioglitizone added onto their blinded study medication

Intervention(s) in this Clinical Trial

• Drug: Saxagliptin + Metformin
  • Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
• Drug: Saxagliptin + Metformin
  • Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
• Drug: Saxagliptin + Metformin
  • Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT)
• Drug: Placebo + Metformin
  • Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT)
• Drug: Pioglitazone
  • Tablets, Oral, 15 - 45 mg (as needed for rescue)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Saxagliptin + Metformin (A)
  • Pioglitazone 15-45 mg (as needed for rescue)
• Experimental: Saxagliptin + Metformin (B)
  • Pioglitazone 15-45 mg (as needed for rescue)
• Experimental: Saxagliptin + Metformin (C)
  • Pioglitazone 15-45 mg (as needed for rescue)
• Placebo Comparator: Placebo+ Metformin (D)
  • Pioglitazone 15-45 mg (as needed for rescue)

Primary Measures

• Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24
  • Time Frame: Baseline, Week 24
    Safety Issue?: No

Secondary Measures

• Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
  • Time Frame: Baseline, Week 24
    Safety Issue?: No
• Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24
  • Time Frame: Week 24
    Safety Issue?: No
• Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)
  • Time Frame: Baseline, Week 24
    Safety Issue?: No

Inclusion Criteria:

• Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
• HbA1c >= 7.0% and <= 10.0 %
• Body mass index <= 40 kg/m2
• Fasting C-peptide >= 1 ng/dL

Exclusion Criteria:

• Symptomatic poorly controlled diabetes
• Recent cardiac or cerebrovascular event
• Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females

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

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00121667

Study ID Number: CV181-014

ClinicalTrials.gov Identifier: NCT00121667

Health Authority: United States: Food and Drug Administration

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