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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2007

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

• Mean reduction in baseline A1C values after 24 weeks of treatment
  • Time Frame: from baseline to Week 24
    Safety Issue?: No

Secondary Measures

• Subjects achieving a glycemic response defined as A1C < 7.0%
  • Time Frame: from baseline to Week 24
    Safety Issue?: No
• Change from baseline in the fasting plasma glucose
  • Time Frame: from baseline to Week 24
    Safety Issue?: No
• Change from baseline in the area under the curve (AUC) for postprandial glucose (PPG) response
  • Time Frame: from baseline to Week 24
    Safety Issue?: No
• Subjects requiring rescue for failing to achieve glycemic targets or the need for discontinuation due to lack of efficacy
  • Time Frame: from baseline to Week 24
    Safety Issue?: No
• To assess the safety and tolerability of each dose of saxagliptin plus metformin IR, saxagliptin plus placebo and metformin IR plus placebo when administered for up to 24 weeks of short-term double-blind treatment
  • Time Frame: up to 24 weeks of short-term double-blind treatment
    Safety Issue?: Yes
• To assess for each saxagliptin treatment group the glycemic parameters in the long-term extension
  • Time Frame: in the long-term extension
    Safety Issue?: No
• To assess the safety and tolerability of each dose of saxagliptin plus metformin IR, saxagliptin plus placebo and metformin IR plus placebo when administered in the long-term extension phase
  • Time Frame: in the long-term extension phase
    Safety Issue?: Yes

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 Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on July 02, 2009

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