A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb AstraZeneca
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00528372

Purpose

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Dapagliflozin Drug: placebo	Phase III

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

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, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 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:

Change from baseline in hemoglobin A1C [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in fasting plasma glucose for each dose of dapagliflozin vs placebo [ Time Frame: after 24 weeks of oral administration of double-blind treatment ] [ Designated as safety issue: No ]
Proportion of subjects achieving a therapeutic glycemic response, defined as AIC < 7.0% [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
Change from baseline in total body weight [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
Change from baseline in fasting plasma glucose [ Time Frame: at Week 1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	560
Study Start Date:	September 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental 2.5 mg QAM	Drug: Dapagliflozin Tablets, Oral, once daily, up to 102 weeks
Arm 2: Experimental 2.5 mg QPM	Drug: Dapagliflozin Tablets, Oral, once daily, up to 102 weeks
Arm 3: Experimental 5 mg QAM	Drug: Dapagliflozin Tablets, Oral, once daily, up to 102 weeks
Arm 4: Experimental 5 mg QPM	Drug: Dapagliflozin Tablets, Oral, once daily, up to 102 weeks
Arm 5: Experimental 10 mg QAM	Drug: Dapagliflozin Tablets, Oral, once daily, up to 102 weeks
Arm 6: Experimental 10 mg QPM	Drug: Dapagliflozin Tablets, Oral, once daily, up to 102 weeks
Arm 7: Placebo Comparator 0 mg QAM & QPM	Drug: placebo Tablets, Oral, once daily, up to 102 weeks
OL Arm 1: Experimental 5 mg QAM	Drug: Dapagliflozin Tablets, Oral, once daily, up to 102 weeks
OL Arm 2: Experimental 10 mg QPM	Drug: Dapagliflozin Tablets, Oral, once daily, up to 102 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control
Drug naive or treated with anti-diabetic medication for < 24 weeks
C-peptide ≥ 1.0 ng/mL
Body Mass Index ≤ 45.0 kg/m2\
Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Exclusion Criteria:

AST and /or ALT > 3.0 times the upper limit of normal
Serum total bilirubin > 1.5 times ULN
Creatinine kinase ≥ 3 times the upper limit of normal
Symptoms of severely uncontrolled diabetes
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528372

Show 79 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

AstraZeneca

Investigators

Study Director:

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: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	MB102-013
Study First Received:	September 11, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00528372
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Mexico: Federal Commission for Protection Against Health Risks; Russia: Ministry of Public Health and Social Development of Russian Federation and Ethic Committee of Federal Supervision Service for Public Health and Social Affairs

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 15, 2009