Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663260
• Other study ID #: MB102-029
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 18, 2008
• Last updated: March 20, 2015
• Start date: June 2008
• Est. completion date: June 2011

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBrazil: Ministry of HealthBrazil: National Health Surveillance AgencyCanada: Health CanadaDenmark: Ministry of HealthFrance: Ministry of HealthIndia: Central Drugs Standard Control OrganizationIndia: Directorate General of Foreign TradeIndia: Indian Council of Medical ResearchIsrael: Ministry of HealthItaly: Ministry of HealthMexico: Ministry of HealthMexico: Federal Commission for Protection Against Health RisksPeru: Ministry of HealthPeru: General Directorate of Pharmaceuticals, Devices, and DrugsSingapore: Health Sciences AuthoritySouth Africa: Department of HealthSpain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

Description:

All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: June 2011
• Est. primary completion date: December 2009
• 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

• Clinical diagnosis of moderate renal impairment

Exclusion Criteria:

• AST and /or ALT > 3.0 times the upper limit of normal

• Serum total bilirubin > 1.5 times ULN

• Symptoms of severely uncontrolled diabetes

• Currently unstable or serious cardiovascular, 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
• Diabetes Mellitus, Type 2
• Renal Insufficiency

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 10 mg, Once Daily, 104 weeks
• Dapagliflozin
Tablets, Oral, 5 mg, Once Daily, 104 weeks
• Placebo
Tablets, Oral, 0 mg, Once Daily, 104 weeks

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Mar Del Plata	Buenos Aires
Argentina	Local Institution	Salta
Argentina	Local Institution	Zarate	Buenos Aires
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Launceston	Tasmania
Australia	Local Institution	St Leonards	New South Wales
Australia	Local Institution	Woollongong	New South Wales
Canada	Local Institution	Barrie	Ontario
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Gatineau	Quebec
Canada	Local Institution	Laval	Quebec
Canada	Local Institution	Regina	Saskatchewan
Canada	Local Institution	Sherbrooke	Quebec
Canada	Local Institution	Thornhill	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Winnipeg	Manitoba
Denmark	Local Institution	Copenhagen Nv
Denmark	Local Institution	Gentofte
Denmark	Local Institution	Hvidovre
France	Local Institution	Besancon Cedex
France	Local Institution	Brest Cedex
France	Local Institution	Paris
France	Local Institution	Paris Cedex 10
France	Local Institution	Poitiers Cedex
India	Local Institution	Bangalore
India	Local Institution	Bangalore
India	Local Institution	Chennai
India	Local Institution	Indore	Madhya Pradesh
India	Local Institution	Pune	Maharashtra
India	Local Institution	Pune, Maharashtra
India	Local Institution	Rajasthan
Italy	Local Institution	Chieri
Italy	Local Institution	Chieti Scalo
Italy	Local Institution	Modena
Italy	Local Institution	Padova
Italy	Local Institution	Perugia
Italy	Local Institution	Pisa
Italy	Local Institution	Roma
Italy	Local Institution	Siena
Mexico	Local Institution	Celaya	Guanajuato
Mexico	Local Institution	Df	Distrito Federal
Mexico	Local Institution	Df	Distrito Federal
Mexico	Local Institution	Df	Distrito Federal
Mexico	Local Institution	Durango
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Monterrey	Nuevo Leon
Peru	Local Institution	Arequipa
Peru	Local Institution	Cercado De Lima	Lima
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Puerto Rico	Local Institution	Caguas
Puerto Rico	Local Institution	San Juan
Singapore	Local Institution	Singapore
Spain	Local Institution	Barcelona
Spain	Local Institution	San Sebastian De Los
Spain	Local Institution	Vizcaya
United States	Community Health Care Of Manchester	Akron	Ohio
United States	Center For Thyroid Diseases And Endocrinology	Beachwood	Ohio
United States	Twin Cities Clinical Research	Brooklyn Center	Minnesota
United States	Low Country Internal Medicine Of Sc, Pa	Charleston	South Carolina
United States	Research Institute Of Dallas	Dallas	Texas
United States	Endocrine Associates Of The Rockies	Denver	Colorado
United States	Valley Research	Fresno	California
United States	Marin Endocrine Care & Research, Inc.	Greenbrae	California
United States	Westbury Medical Clinic P.A.	Houston	Texas
United States	Kcva Medical Center Research Svc (151)	Kansas City	Missouri
United States	Office Of Richard Cherlin, Md	Los Gatos	California
United States	Panhandle Family Care Associates	Marianna	Florida
United States	Rogue Valley Clinical Research	Medford	Oregon
United States	Vista Medical Research, Inc.	Mesa	Arizona
United States	Aurora Advanced Healthcare	Milwaukee	Wisconsin
United States	Zablocki Veterans Affairs Medical Center	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Carolina Health Specialists	Myrtle Beach	South Carolina
United States	Slocum-Dickson Medical Group, Pllc	New Hartford	New York
United States	The Strelitz Diabetes Center	Norfolk	Virginia
United States	Diabetes Medical Center Of California	Northridge	California
United States	Univ Of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	Capital Clinical Research Center	Olympia	Washington
United States	Va Nebraska-Western Iowa Health Care System (Nwihcs)	Omaha	Nebraska
United States	Drexel University College Of Medicine	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Apex Research Of Riverside	Riverside	California
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Cedar Research Llc	Tacoma	Washington
United States	Genesis Clinical Research	Tampa	Florida
United States	La Biomed At Harbor Ucla Med Ctr.	Torrance	California
United States	University Of Medicine And Dentistry Of New Jersey	Voorhees	New Jersey
United States	Physician Research, Inc.	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Denmark,  France,  India,  Italy,  Mexico,  Peru,  Puerto Rico,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in glycosylated hemoglobin (A1C)		after 24 weeks	No
Secondary	The change in estimated glomerular filtration rate (marker of kidney function)		after 52 weeks	No
Secondary	The change in estimated creatinine clearance (marker of kidney function)		after 52 weeks	No
Secondary	The change in fasting plasma glucose		after 24 weeks	No
Secondary	The change in body weight		after 24 weeks	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