Clinical trial NCT00663260: Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-04-22
Enrollment: 631
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]
timeFrame: From Baseline to Week 24
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
measure: Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Vista Medical Research, Inc.
state: Arizona
city: Fresno
country: United States
facility: Valley Research
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Care & Research, Inc.
state: California
city: Los Gatos
country: United States
facility: Office Of Richard Cherlin, Md
state: California
city: Northridge
country: United States
facility: Diabetes Medical Center Of California
state: California
city: Riverside
country: United States
facility: Apex Research Of Riverside
state: California
city: Torrance
country: United States
facility: La Biomed At Harbor Ucla Med Ctr.
state: California
city: Denver
country: United States
facility: Endocrine Associates Of The Rockies
state: Colorado
city: Marianna
country: United States
facility: Panhandle Family Care Associates
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research
state: Florida
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Brooklyn Center
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Kansas City
country: United States
facility: Kcva Medical Center Research Svc (151)
state: Missouri
city: Omaha
country: United States
facility: Va Nebraska-Western Iowa Health Care System (Nwihcs)
state: Nebraska
city: Voorhees
country: United States
facility: University Of Medicine And Dentistry Of New Jersey
state: New Jersey
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New Hartford
country: United States
facility: Slocum-Dickson Medical Group, Pllc
state: New York
city: Akron
country: United States
facility: Community Health Care Of Manchester
state: Ohio
city: Beachwood
country: United States
facility: Center For Thyroid Diseases And Endocrinology
state: Ohio
city: Zanesville
country: United States
facility: Physician Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Univ Of Oklahoma Health Science Center
state: Oklahoma
city: Medford
country: United States
facility: Rogue Valley Clinical Research
state: Oregon
city: Philadelphia
country: United States
facility: Drexel University College Of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Internal Medicine Of Sc, Pa
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Health Specialists
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Dallas
country: United States
facility: Research Institute Of Dallas
state: Texas
city: Houston
country: United States
facility: Westbury Medical Clinic P.A.
state: Texas
city: Norfolk
country: United States
facility: The Strelitz Diabetes Center
state: Virginia
city: Olympia
country: United States
facility: Capital Clinical Research Center
state: Washington
city: Tacoma
country: United States
facility: Cedar Research Llc
state: Washington
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare
state: Wisconsin
city: Milwaukee
country: United States
facility: Zablocki Veterans Affairs Medical Center
state: Wisconsin
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Zarate
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Salta
country: Argentina
facility: Local Institution
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: St Leonards
country: Australia
facility: Local Institution
state: New South Wales
city: Woollongong
country: Australia
facility: Local Institution
state: New South Wales
city: Launceston
country: Australia
facility: Local Institution
state: Tasmania
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Barrie
country: Canada
facility: Local Institution
state: Ontario
city: Thornhill
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Gatineau
country: Canada
facility: Local Institution
state: Quebec
city: Laval
country: Canada
facility: Local Institution
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution
state: Quebec
city: Regina
country: Canada
facility: Local Institution
state: Saskatchewan
city: Copenhagen Nv
country: Denmark
facility: Local Institution
city: Gentofte
country: Denmark
facility: Local Institution
city: Hvidovre
country: Denmark
facility: Local Institution
city: Besancon Cedex
country: France
facility: Local Institution
city: Brest Cedex
country: France
facility: Local Institution
city: Paris Cedex 10
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Poitiers Cedex
country: France
facility: Local Institution
city: Indore
country: India
facility: Local Institution
state: Madhya Pradesh
city: Pune
country: India
facility: Local Institution
state: Maharashtra
city: Bangalore
country: India
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
city: Chennai
country: India
facility: Local Institution
city: Pune, Maharashtra
country: India
facility: Local Institution
city: Rajasthan
country: India
facility: Local Institution
city: Chieri
country: Italy
facility: Local Institution
city: Chieti Scalo
country: Italy
facility: Local Institution
city: Modena
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Perugia
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Celaya
country: Mexico
facility: Local Institution
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Durango
country: Mexico
facility: Local Institution
city: Cercado De Lima
country: Peru
facility: Local Institution
state: Lima
city: Arequipa
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Caguas
country: Puerto Rico
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: San Sebastian De Los
country: Spain
facility: Local Institution
city: Vizcaya
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Fioretto P, Stefansson BV, Johnsson E, Cain VA, Sjostrom CD. Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia. 2016 Sep;59(9):2036-9. doi: 10.1007/s00125-016-4017-1. Epub 2016 Jun 15. No abstract available.
citation: Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25.