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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01095653
First received: March 26, 2010
Last updated: June 6, 2014
Last verified: June 2014
  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:


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
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:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01095653     History of Changes
Other Study ID Numbers: MB102-054
Study First Received: March 26, 2010
Last Updated: June 6, 2014
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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014