Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00121641

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Placebo Drug: Saxagliptin	Phase III

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

Drug Information available for: Saxagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bristol-Myers Squibb:

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.

Estimated Enrollment:	460
Study Start Date:	July 2005

Arms	Assigned Interventions
A1: Placebo Comparator	Drug: Placebo Tablets, Oral, 0mg, Once daily, 24 weeks.
A2: Active Comparator	Drug: Saxagliptin Tablets, Oral, 2.5 mg, Once daily, 24 weeks.
A3: Active Comparator	Drug: Saxagliptin Tablets, Oral, 5 mg, Once daily, 24 weeks.
A4: Active Comparator	Drug: Saxagliptin Tablets, Oral, 10mg, Once daily, 24 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 77 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121641

Show 135 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

Study ID Numbers:	CV181-011
Study First Received:	July 15, 2005
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00121641
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009