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A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00357370
First received: July 26, 2006
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.


Condition Intervention Phase
Type 2 Diabetes
Drug: Dapagliflozin
Drug: Placebo
Phase 2
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 Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects With Type 2 Diabetes Treated Aggressively But Not Controlled on Combination Antihyperglycemic Therapy With Metformin and/or Thiazolidinedione (TZD) and Insulin.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from baseline in hemoglobin A1C [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in the proportion of subjects achieving therapeutic glycemic responses [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in the total daily dose of insulin [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: October 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
20 mg
Drug: Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Other Name: BMS-512148
Experimental: Cohort 2 - Arm 1
10 mg
Drug: Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Other Name: BMS-512148
Experimental: Cohort 2 - Arm 2
20 mg
Drug: Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Other Name: BMS-512148
Placebo Comparator: Cohort 2 - Arm 3 Drug: Placebo
Tablets, Oral, 0 mg, once daily, up to 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
  • Subjects receiving insulin and metformin and/or a thiazolidinedione
  • Body Mass Index <=45.0 kg/m2
  • Serum creatinine <1.5 mg/dL for men or <1.4 mg/dL for women
  • No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be <3 g/24 hrs)

Exclusion Criteria:

  • History of type 1 diabetes
  • AST and/or ALT >2.5 times the upper limit of normal
  • Creatinine kinase ≥3 times the upper limit of normal
  • Symptoms of severely uncontrolled diabetes
  • History of hypoglycemic unawareness
  • 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: NCT00357370

  Show 23 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00357370     History of Changes
Other Study ID Numbers: MB102-009
Study First Received: July 26, 2006
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014