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Add-on to Thiazolidinedione (TZD) Failures

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00683878
First received: May 22, 2008
Last updated: July 28, 2010
Last verified: July 2010
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 subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied


Condition Intervention Phase
Type 2 Diabetes
 Drug: Dapagliflozin
Drug: Placebo
 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 in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy 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 hemoglobin A1C [ Time Frame: at Wk 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in total body weight; 120 min post challenge plasma glucose as response to OGTT; FPG; waist circumference; & total body weight in subjects with baseline BMI ≥ 27 kg/m2 [ Time Frame: at Wk 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as AIC<7.0% [ Time Frame: at Wk 24 ] [ Designated as safety issue: No ]

Enrollment: 420
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Dapagliflozin
Tablets, Oral, 5.0 mg, once daily, up to 48 weeks
Other Name: BMS-512148
Experimental: Arm 2 Drug: Dapagliflozin
Tablets, Oral, 10.0 mg, once daily, up to 48 weeks
Other Name: BMS-512148
Placebo Comparator: Arm 3 Drug: Placebo
Tablets, Oral, 0 mg, once daily, up to 48 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
  • All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
  • C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
  • Body Mass Index ≤ 45.0 kg/m²

Exclusion Criteria:

  • AST and /or ALT > 2.5 times the upper limit of normal
  • Serum total bilirubin > 2 mg/dL (34.2 µmol/L)
  • Creatinine kinase > 3.0 times the upper limit of normal
  • Symptoms of severely uncontrolled diabetes
  • Serum creatinine ≥ 2.0 mg/dL
  • Calculated Cr-Clearance < 50 ml/min (calculated by Cockroft-Gault formula)
  • 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: NCT00683878

  Show 89 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
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 by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00683878     History of Changes
Other Study ID Numbers: MB102-030
Study First Received: May 22, 2008
Last Updated: July 28, 2010
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
India: Central Drugs Standard Control Organization
Mexico: Federal Commission for Protection Against Health Risks
Peru: Instituto Nacional de Salud (INS)
Philippines: Bureau of Food and Drugs
Taiwan: Department of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013