Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

The purpose of this clinical research study is to learn whether Saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise. The safety of this treatment will also be studied.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Conditions

Diabetes Mellitus, Type 2

Study Type

Interventional

Study Design

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

Further Details

Primary Outcome Measures:

• To compare the change from baseline in HbA1c achieved with each dose of BMS-477118 versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as HbA1c >7.0% and <10.0%.

Secondary Outcome Measures:

• To compare each dose of BMS-477118 versus placebo after 24 weeks of oral administration of double-blind therapy for specific labs.

Study Start

July 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 77 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• Type 2 diabetes mellitus
• Drug naive
• HbA1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)
• Fasting C-peptide >= 1 ng/mL
• Body mass index <= 40 kg/m²

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 Women of Child Bearing Potential

Total Enrolment

460

Contact Details

Australian Locations:

• Local Institution, Sydney, New South Wales, Australia
• Local Institution, Woollongong, New South Wales, Australia
• Local Institution, Kippa Ring, Queensland, Australia
• Local Institution, Meadowbrook, Queensland, Australia
• Local Institution, Brisbane, Queensland, Australia
• Local Institution, Adelaide, South Australia, Australia
• Local Institution, Woodville South, South Australia, Australia
• Local Institution, Perth, Western Australia, Australia

For more information, refer to Bristol-Myers Squibb Clinical Trials