Add-on to Thiazolidinedione (TZD) Failures - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb AstraZeneca
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00683878

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 III

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	417
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Dapagliflozin Tablets, Oral, 5.0 mg, once daily, up to 48 weeks
Arm 2: Experimental	Drug: Dapagliflozin Tablets, Oral, 10.0 mg, once daily, up to 48 weeks
Arm 3: Placebo Comparator	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

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 136 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

AstraZeneca

Investigators

Study Director:

Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	MB102-030
Study First Received:	May 22, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00683878
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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
2,4-thiazolidinedione

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009