Add-on to Thiazolidinedione (TZD) Failures

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683878
• Other study ID #: MB102-030
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2008
• Last updated: March 24, 2015
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaCanada: Health CanadaIndia: Central Drugs Standard Control OrganizationMexico: Federal Commission for Protection Against Health RisksPeru: Instituto Nacional de Salud (INS)Philippines: Bureau of Food and DrugsTaiwan: Department of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 5.0 mg, once daily, up to 48 weeks
• Dapagliflozin
Tablets, Oral, 10.0 mg, once daily, up to 48 weeks
• Placebo matching Dapagliflozin
Tablets, Oral, 0 mg, once daily, up to 48 weeks
• Thiazolidinedione (Pioglitazone)
Tablets, = 30 mg, Once daily, up to 48 weeks

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Ciudad Auton	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Zarate	Buenos Aires
Canada	Local Institution	Halifax	Nova Scotia
Canada	Local Institution	Mirabel	Quebec
Canada	Local Institution	Moncton	New Brunswick
Canada	Local Institution	Mount Pearl	Newfoundland and Labrador
Canada	Local Institution	Sarnia	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Winnipeg	Manitoba
India	Local Institution	Hariyana
India	Local Institution	Mumbai
India	Local Institution	Vellore
Mexico	Local Institution	Chihuahua
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Merida	Yucatan
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Monterrey, Nl	Nuevo Leon
Mexico	Local Institution	Veracruz
Mexico	Local Institution	Zapopan	Jalisco
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Philippines	Local Institution	Cebu City
Philippines	Local Institution	Manila
Philippines	Local Institution	Pasig City
Puerto Rico	Local Institution	Ponce
Taiwan	Local Institution	Changhua
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taipei
United States	Central Florida Clinical Trials	Altamonte Springs	Florida
United States	Pinnacle Research Group, Llc	Anniston	Alabama
United States	Aurora Family Medicine Center, P.C.	Aurora	Colorado
United States	Metrolina Internal Medicine	Charlotte	North Carolina
United States	The Center For Nutrition & Preventive Medicine, Pllc	Charlotte	North Carolina
United States	Cedar Crosse Research Center	Chicago	Illinois
United States	Health First Clinical Research Group, Inc.	Chipley	Florida
United States	Columbia Clinical Research, Inc.	Columbia	South Carolina
United States	Clinical Therapeutics Corporation	Coral Gables	Florida
United States	Clinical Innovations, Inc.	Costa Mesa	California
United States	Dallas Diabetes & Endocrine Center	Dallas	Texas
United States	Providence Health Partners - Center For Clinical Research	Dayton	Ohio
United States	Denver Internal Medicine	Denver	Colorado
United States	St. Mary'S Center For Diabetes And Endocrinology	Grand Rapids	Michigan
United States	Marin Endocrine Care And Research, Inc.	Greenbrae	California
United States	Office Of Dr. Michelle Zaniewski Singh	Houston	Texas
United States	Village Family Practice	Houston	Texas
United States	Endocrine Research Associates	Jackson	Mississippi
United States	Westside Center For Clinical Research	Jacksonville	Florida
United States	Holston Medical Group	Kingsport	Tennessee
United States	Association Of International Professionals	Las Vegas	Nevada
United States	Northstate Clinical Research	Lenoir	North Carolina
United States	Family Medical Associates	Levittown	Pennsylvania
United States	Little Rock Family Practice Clinic	Little Rock	Arkansas
United States	Torrance Clinical Research	Lomita	California
United States	Randall Shue, D.O.	Los Angeles	California
United States	Panhandle Family Care Associates	Marianna	Florida
United States	Baptist Diabetes Associates, Pa	Miami	Florida
United States	Suncoast Clinical Res Inc.	New Port Richey	Florida
United States	Diabetes Medical Center Of California	Northridge	California
United States	Olive Branch Family Medical Center	Olive Branch	Mississippi
United States	Iicr	Ozark	Alabama
United States	Desert Medical Advances	Palm Desert	California
United States	43rd Medical Associates, P.C.	Phoenix	Arizona
United States	Banksville Medical, Pc	Pittsburgh	Pennsylvania
United States	Brookside Family Practice & Pediatrics	Pottstown	Pennsylvania
United States	Avastra Clinical Trials	Redlands	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Danny W. Jackson P.A.	Rolling Fork	Mississippi
United States	Sierra Clinical Research	Roseville	California
United States	Diabetes & Glandular Disease Research Assoc,, Inc.	San Antonio	Texas
United States	Ritchken & First M.D.'S	San Diego	California
United States	Advantage Clinical Research	Santa Ana	California
United States	Searcy Medical Center	Searcy	Arkansas
United States	William L. Gray, Md	Spokane	Washington
United States	Encompass Clinical Research	Spring Valley	California
United States	Stone Mountain Clinical Research	Stone Mountain	Georgia
United States	Southeastern Research Associates, Inc.	Taylors	South Carolina
United States	Clinical Research Advantage Inc / Desert Clinical Res, Llc	Tempe	Arizona
United States	Clinical Research Advantage, Inc	Tempe	Arizona
United States	Physicians Research Center	Toms River	New Jersey
United States	Diabetes Research Center	Tustin	California
United States	Northwest Indiana Center For Clinical Research	Valparaiso	Indiana
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Professional Research Network Of Kansas	Wichita	Kansas
United States	New Hanover Medical Research	Wilmington	North Carolina
United States	Physician Research, Inc.	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  India,  Mexico,  Peru,  Philippines,  Puerto Rico,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hemoglobin A1C		at Wk 24	No
Secondary	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		at Wk 24	No
Secondary	Proportion of subjects achieving a therapeutic glycemic response, defined as AIC<7.0%		at Wk 24	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm