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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Saxagliptin (Drug)

Phase: Phase 3

Status: No longer recruiting

Sponsored by: Bristol-Myers Squibb

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. The safety of this treatment will also be studied.

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"

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in HbA1c to week 24 with each dose of BMS-477118 vs placebo

Secondary outcome: 1) Change from baseline at week 24 in the area under the curve in post-prandial assessments

Minimum age: 18 Years. Maximum age: 77 Years. Gender(s): Both.

Criteria:

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 >= 1ng/dL

- women or child bearing potential

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

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Starting date: July 2005
Last updated: March 5, 2007