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

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: Dapagliflozin matching Placebo Drug: Metformin Drug: Metformin (as needed for rescue based on protocol specific criteria)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Exercise and Physical Fitness

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

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 ]

Enrollment:	560
Study Start Date:	September 2007
Study Completion Date:	July 2010
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 - Dapagliflozin 2.5 mg QAM Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)	Drug: Dapagliflozin Tablets, Oral, 2.5 mg, QAM, once daily, up to 102 weeks Other Name: BMS-512148 Drug: Metformin (as needed for rescue based on protocol specific criteria) Open Label Tablets, Oral, 500-2000 mg
Experimental: Group 1 - Dapagliflozin 2.5 mg QPM Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)	Drug: Dapagliflozin Tablets, Oral, 2.5 mg, QPM, once daily, up to 102 weeks Other Name: BMS-512148 Drug: Metformin (as needed for rescue based on protocol specific criteria) Open Label Tablets, Oral, 500-2000 mg
Experimental: Group 1 - Dapagliflozin 5 mg QAM Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)	Drug: Dapagliflozin Tablets, Oral, 5 mg, QAM, once daily, up to 102 weeks Other Name: BMS-512148 Drug: Metformin (as needed for rescue based on protocol specific criteria) Open Label Tablets, Oral, 500-2000 mg
Experimental: Group 1 - Dapagliflozin 5 mg QPM Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)	Drug: Dapagliflozin Tablets, Oral, 5 mg, QPM, once daily, up to 102 weeks Other Name: BMS-512148 Drug: Metformin (as needed for rescue based on protocol specific criteria) Open Label Tablets, Oral, 500-2000 mg
Experimental: Group 1 - Dapagliflozin 10 mg QAM Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)	Drug: Dapagliflozin Tablets, Oral, 10 mg, QAM, once daily, up to 102 weeks Other Name: BMS-512148 Drug: Metformin (as needed for rescue based on protocol specific criteria) Open Label Tablets, Oral, 500-2000 mg
Experimental: Group 1 - Dapagliflozin 10 mg QPM Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)	Drug: Dapagliflozin Tablets, Oral, 10 mg, QPM, once daily, up to 102 weeks Other Name: BMS-512148 Drug: Metformin (as needed for rescue based on protocol specific criteria) Open Label Tablets, Oral, 500-2000 mg
Placebo Comparator: Group 1 - Dapagliflozin Placebo QAM/QPM Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)	Drug: Dapagliflozin matching Placebo Tablets, Oral, 0 mg, QAM & QPM, once daily, up to 102 weeks Drug: Metformin Tablets, Oral, 500 mg, QAM, starting at week 24 up to 102 weeks Drug: Metformin (as needed for rescue based on protocol specific criteria) Open Label Tablets, Oral, 500-2000 mg
Experimental: OL Arm - Dapagliflozin 5 mg QAM Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)	Drug: Dapagliflozin Tablets, Oral, 5 mg, QAM, once daily, up to 102 weeks Other Name: BMS-512148 Drug: Metformin (as needed for rescue based on protocol specific criteria) Open Label Tablets, Oral, 500-2000 mg
Experimental: OL Arm - Dapagliflozin 10 mg QAM Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)	Drug: Dapagliflozin Tablets, Oral, 10 mg, QAM, once daily, up to 102 weeks Other Name: BMS-512148 Drug: Metformin (as needed for rescue based on protocol specific criteria) Open Label Tablets, Oral, 500-2000 mg

Detailed Description:

All eligible subjects will receive single-blind placebo medication during the 2 week lead-in period. All arms may include the addition of open label metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)

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 78 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

AstraZeneca

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional 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

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00528372 History of Changes
Other Study ID Numbers:	MB102-013
Study First Received:	September 11, 2007
Last Updated:	December 15, 2010
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

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013