Clinical trial NCT00736879: Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-08-18
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 diet and exercise alone. The safety of this treatment will also be studied


Eligibility criteria: Inclusion Criteria:

* Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
* Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
* C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
* Body Mass Index ≤ 45 kg/m²
* Must be able to perform self monitoring of blood glucose

Exclusion Criteria:

* aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3\* upper limit of normal (ULN)
* Serum Total bilirubin \>2 mg/dL (34.2 µmol/L)
* Creatinine kinase \>3\* ULN
* Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
* Currently unstable or serious cardiovascular, renal, 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) - All Randomized Participants
timeFrame: Baseline (Day 1), Week 24
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (LOCF) - Randomized Participants
timeFrame: Baseline (Day 1), Week 24
measure: Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (LOCF) - Randomized Participants
timeFrame: Baseline (Day 1), Week 24
measure: Adjusted Mean Change From Baseline in Effect on 2-hour Post Liquid Meal Glucose at Week 24 (LOCF) - Randomized Participants
timeFrame: Baseline (Day 1), Week 24
measure: Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response at Week 24 (LOCF) - Randomized Participants
timeFrame: Baseline (Day 1), Week 24
measure: Adjusted Mean Change From Baseline in Waist Circumference at Week 24 (LOCF) - Randomization Participants
timeFrame: Baseline (Day 1), Week 24
measure: Number of Participants With Deaths, Serious AEs (SAEs), Adverse Events (AEs), Discontinuation Due to AEs, During the 12 Week Double Blind Period, Including Data After Rescue - All Treated Participants
timeFrame: Day 1 of Double Blind Period to end of Week 24 Plus 30 days
measure: Number of Participants With Adverse Events of Special Interest During the 12 Week Double Blind Period - All Treated Participants
timeFrame: Baseline to last dose plus 4 days in 12 Week Double Blind Period
measure: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure at Week 24, Including Data After Rescue - Treated Participants
timeFrame: Baseline (Day 1), Week 24
measure: Mean Change From Baseline in Seated Heart Rate at Week 24 - Treated Participants
timeFrame: Baseline (Day 1), Week 24
measure: Number of Participants With Normal or Abnormal Electrocardiogram Summary Tracing at Week 24 (LOCF) - Treated Participants
timeFrame: Week 24
measure: Number of Participants With Marked Laboratory Abnormalities in 24 Week Double Blind Treatment Period - Treated Participants
timeFrame: Baseline to Week 24/end of treatment plus 4 days
Other outcomes:
Locations:
city: Litchfield Park
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: 43rd Medical Associates, P.C.
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Fresno
country: United States
facility: Valley Research
state: California
city: Lomita
country: United States
facility: Marina Raikhel, Md, Faafp
state: California
city: Los Gatos
country: United States
facility: Richard S. Cherlin, Md
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Greeley
country: United States
facility: Family Physicians Of Greeley
state: Colorado
city: New London
country: United States
facility: Coastal Connecticut Research, Llc
state: Connecticut
city: Altamonte Springs
country: United States
facility: Central Florida Clinical Trials, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Westside Center For Clinical Research
state: Florida
city: Marianna
country: United States
facility: Panhandle Family Care Associates
state: Florida
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc.
state: Georgia
city: Belzoni
country: United States
facility: Belzoni Clinical Research
state: Mississippi
city: Hamilton
country: United States
facility: R-Research
state: New Jersey
city: Syracuse
country: United States
facility: Internist Associates Of Central New York
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group
state: New York
city: Morehead City
country: United States
facility: Down East Medical Associates, Pa
state: North Carolina
city: Akron
country: United States
facility: James J. Brown, Md
state: Ohio
city: Oklahoma
country: United States
facility: Integris Family Care South
state: Oklahoma
city: Taylors
country: United States
facility: Southeastern Research Associates, Inc.
state: South Carolina
city: San Antonio
country: United States
facility: Abbott Clinical Research Group, Inc
state: Texas
city: Midvale
country: United States
facility: Avastra Clinical Trials
state: Utah
city: Salt Lake City
country: United States
facility: Optimum Clinical Research, Inc.
state: Utah
city: Olympia
country: United States
facility: Capital Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Stephen G. Danley, Do
state: Washington
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Coquitlam
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Bathurst
country: Canada
facility: Local Institution
state: New Brunswick
city: Ajax
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Waterloo
country: Canada
facility: Local Institution
state: Ontario
city: Drummondville
country: Canada
facility: Local Institution
state: Quebec
city: L'Ancienne Lorette
country: Canada
facility: Local Institution
state: Quebec
city: St-Leonard
country: Canada
facility: Local Institution
state: Quebec
city: Ahmedabad
country: India
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
city: Jaipur
country: India
facility: Local Institution
city: Jaipur
country: India
facility: Local Institution
city: Df
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Durango
country: Mexico
facility: Local Institution
city: Mexico City
country: Mexico
facility: Local Institution
city: Veracruz
country: Mexico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Kursk
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: Smolensk
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St.Petersburg
country: Russian Federation
facility: Local Institution
city: Benoni
country: South Africa
facility: Local Institution
state: Gauteng
city: Soweto
country: South Africa
facility: Local Institution
state: Gauteng
city: Paarl
country: South Africa
facility: Local Institution
state: Western Cape
city: Tygerberg
country: South Africa
facility: Local Institution
state: Western Cape
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.