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Add-on to Thiazolidinedione (TZD) Failures

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: May 22, 2008
Last updated: March 24, 2015
Last verified: March 2015
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 matching Dapagliflozin
Drug: Thiazolidinedione (Pioglitazone)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from baseline in hemoglobin A1C [ Time Frame: at Wk 24 ]

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 ]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as AIC<7.0% [ Time Frame: at Wk 24 ]

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
Drug: Thiazolidinedione (Pioglitazone)
Tablets, ≥ 30 mg, Once daily, up to 48 weeks
Experimental: Arm 2 Drug: Dapagliflozin
Tablets, Oral, 10.0 mg, once daily, up to 48 weeks
Other Name: BMS-512148
Drug: Thiazolidinedione (Pioglitazone)
Tablets, ≥ 30 mg, Once daily, up to 48 weeks
Placebo Comparator: Arm 3 Drug: Placebo matching Dapagliflozin
Tablets, Oral, 0 mg, once daily, up to 48 weeks
Drug: Thiazolidinedione (Pioglitazone)
Tablets, ≥ 30 mg, Once daily, up to 48 weeks


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

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
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 identifier: NCT00683878

  Show 89 Study Locations
Sponsors and Collaborators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00683878     History of Changes
Other Study ID Numbers: MB102-030 
Study First Received: May 22, 2008
Last Updated: March 24, 2015

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on February 17, 2017