A Phase III Study of BMS-512148 (Dapagliflozin) in Asian 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 Asian 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: Metformin Drug: Dapagliflozin Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) 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 Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Dapagliflozin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change from baseline in HbA1c for each dose of dapagliflozin vs placebo [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in Fasting Plasma Glucose (FPG) [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
Change from baseline in 2hr-post meal glucose [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 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 ]


Enrollment:	393
Study Start Date:	June 2010
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1	Drug: Dapagliflozin Tablets, Oral, 5 mg, Once daily, 24 weeks Other Name: BMS-512148 Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks Other Name: Glucophage® Drug: Dapagliflozin Placebo Tablets, Oral, 0 mg, Once daily, 24 weeks
Experimental: Group 2	Drug: Dapagliflozin Tablets, Oral, 10 mg, Once daily, 24 weeks Other Name: BMS-512148 Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks Other Name: Glucophage® Drug: Dapagliflozin Placebo Tablets, Oral, 0 mg, Once daily, 24 weeks
Experimental: Group 3	Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks Other Name: Glucophage® Drug: Dapagliflozin Placebo Tablets, Oral, 0 mg, Once daily, 24 weeks

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females, 18 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

Exclusion Criteria:

AST and/or ALT > 3 times ULN
Serum total bilirubin > 2 mg/dL
Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
Creatine kinase ≥ 3 times ULN
Symptoms of severely uncontrolled diabetes
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095653

Show 39 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trial Information This link exits the ClinicalTrials.gov site

BMS clinical trial educational resource This link exits the ClinicalTrials.gov site

Investigator Inquiry form 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:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01095653 History of Changes
Other Study ID Numbers:	MB102-054
Study First Received:	March 26, 2010
Last Updated:	March 20, 2015
Health Authority:	China: Food and Drug Administration India: Drugs Controller General of India Korea: Food and Drug Administration Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on September 30, 2016