Add-on to Thiazolidinedione (TZD) Failures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00683878
First received: May 22, 2008
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 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
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:


Further study details as provided by AstraZeneca:

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
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

  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
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: NCT00683878

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

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00683878     History of Changes
Other Study ID Numbers: MB102-030
Study First Received: May 22, 2008
Last Updated: June 6, 2014
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
Pioglitazone
2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014