Text Size

A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01095666
First received: March 26, 2010
Last updated: June 18, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Dapagliflozin
Drug: Metformin
Drug: Dapagliflozin Placebo
Drug: Pioglitazone
 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 in Combination With Metformin in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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 ]

Estimated Enrollment: 444
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (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, 1500-3000 mg, Twice daily, 24 weeks
Other Name: Glucophage®
Drug: Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks
Drug: Pioglitazone
Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Experimental: Group 2 Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 24 weeks
Other Name: BMS-512148
Drug: Metformin
Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks
Other Name: Glucophage®
Drug: Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks
Drug: Pioglitazone
Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Experimental: Group 3 Drug: Metformin
Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks
Other Name: Glucophage®
Drug: Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks
Drug: Pioglitazone
Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095666

  Show 35 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  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

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01095666     History of Changes
Other Study ID Numbers: MB102-055
Study First Received: March 26, 2010
Last Updated: June 18, 2012
Health Authority: China: Food and Drug Administration
India: Drugs Controller General of India
Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013