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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00121667

Purpose

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.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride 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 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"

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	720
Study Start Date:	August 2005
Study Completion Date:	August 2006

Arms	Assigned Interventions
A1: Placebo Comparator	Drug: Placebo Tablets, Oral, 0mg, Once daily, 24 weeks.
A2: Active Comparator	Drug: Saxagliptin + Metformin Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily, 24 weeks.
A3: Active Comparator	Drug: Saxagliptin + Metformin Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily, 24 weeks.
A4: Active Comparator	Drug: Saxagliptin + Metformin Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121667

Show 154 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:	CV181-014
Study First Received:	July 18, 2005
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00121667
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009