The purpose of this clinical research study is to determine whether dapagliflozin can
improve (decrease) blood glucose values in patients with Type 2 diabetes who have never been
treated with medication or have been taking medication for less than 24 weeks since their
original diabetes diagnosis. The safety of this treatment will also be studied.
Minimum age: 18 Years.
Maximum age: 77 Years.
Gender(s): Both.
Key Inclusion Criteria
- Males and females, aged 18 to 77 years
- Type 2 diabetes with inadequate glycemic control, defined as: Group 1, hemoglobin A1c
(HbA1c) ≥7% and ≤10%; Group 2, HbA1c ≥10. 1% and ≤12. 0%
- Drug naive, defined as never having received prescription medications for diabetes,
having received prescription medications for diabetes for <24 weeks since the
original diagnosis
- C-peptide ≥1. 0 ng/mL at enrollment
- Body Mass Index ≤ 45. 0 kg/m^2 at enrollment
Key Exclusion Criteria
- Urine albumin: creatinine ratio >1,800 mg/g
- Aspartate aminotransferase >3*upper limit of normal (ULN)
- Alanine aminotransferase >3*ULN
- Serum total bilirubin >2*ULN
- Serum creatinine ≥1. 5 mg/dL for men; ≥1. 4 mg/dLfor women
- Calcium value outside of the central laboratory normal reference range
- Positive hepatitis B surface antigen
- Positive anti-hepatitis C virus antibody
- Hemoglobin ≤11 g/dL for men; hemoglobin ≤10 g/dL for women
- Creatine kinase >3*ULN
- Abnormal free T4 values
- History of diabetes insipidus
- Symptoms of poorly controlled diabetes, including marked polyuria and polydipsia with
greater than 10% weight loss in the 3 months prior to enrollment
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or
diastolic blood pressure ≥110 mm Hg
- Any of the following within 6 months of enrollment: Myocardial infarction, cardiac
surgery or revascularization, unstable angina, unstable congestive heart failure
(CHF), CHF New York Heart Association Class III or IV status, transient ischemic
attack or significant cerebrovascular disease, unstable or previously undiagnosed
arrhythmia
- History of unstable or rapidly progressing renal disease
- Conditions of congenital renal glucosuria
- Significant hepatic disease, including chronic active hepatitis and/or severe hepatic
insufficiency
- Documented history of hepatotoxicity with any medication
- Documented history of severe hepatobiliary disease
- History of hemoglobinopathy, with the exception of sickle cell trait, thalassemia
minor, or chronic or recurrent hemolysis
- Donation of blood or blood products to a blood bank, blood transfusion, or
participation in a clinical study requiring withdrawal of >400 mL of blood during the
6 weeks prior to enrollment
- Malignancy (with the exception of treated basal cell or treated squamous cell
carcinoma) within 5 years of enrollment visit
- Known immunocompromised status, including individuals who had undergone organ
transplantation or who had positive HIV results
- Administration of any antidiabetic therapy for more than 14 days (consecutive or not)
during the 12 weeks prior to enrollment
- Administration of any antidiabetic therapy, other than any previously specified, at
any dose, at any time during the 4 weeks prior to enrollment
- Replacement or chronic systemic corticosteroid therapy, defined as any dose of
systemic corticosteroid taken for >4 weeks within 3 months prior to enrollment
- History of bariatric surgery or lap-band procedure
- Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine,
diethylpropion, methamphetamine, and/or phendimetrazine, within 30 days of enrollment
Local Institution, Aguascalientes 20230, Mexico
Local Institution, Durango 34000, Mexico
Local Institution, Kursk 305035, Russian Federation
Local Institution, Moscow 115093, Russian Federation
Local Institution, Saint-Petersburg 191015, Russian Federation
Local Institution, Smolensk 214019, Russian Federation
Local Institution, St. Petersburg 195257, Russian Federation
Local Institution, St.Petersburg 195112, Russian Federation
Local Institution, Yaroslaval 150003, Russian Federation
Local Institution, Calgary, Alberta T2R 0X7, Canada
43rd Medical Associates, P.C., Phoenix, Arizona 85051, United States
Clin Res Advantage, Inc/East Valley Family Physicians, Plc, Tempe, Arizona 85282, United States
Clinical Research Advantage, Inc, Tempe, Arizona 85282, United States
Local Institution, Tijuana, Baja California 22320, Mexico
Local Institution, Kelowna, British Columbia V1Y 2H4, Canada
Valley Research, Fresno, California 93720, United States
Cherlin, Richard, Los Gatos, California 95032, United States
Ritchken & First M.D.'S, San Diego, California 92117, United States
Torrance Clinical Research, Torrance, California 90717, United States
Aurora Family Medicine Center, P.C., Aurora, Colorado 80012, United States
Expresscare Clinical Research, Colorado Springs, Colorado 80909, United States
Center For Internal Medicine, Denver, Colorado 80209, United States
Denver Internal Medicine Group, Denver, Colorado 80209, United States
Local Institution, Guadalajara, Distrito Federal 44670, Mexico
Local Institution, Mexico, D. F., Distrito Federal 06726, Mexico
Central Florida Clinical Trials, Altamonte Springs, Florida 32701, United States
Family Care Associates, Chipley, Florida 32428, United States
Westside Center For Clinical Research, Jacksonville, Florida 32205, United States
Panhandle Family Care Associates, Marianna, Florida 32446, United States
Local Institution, Guadalajara, Jalisco 44100, Mexico
Local Institution, Guadalajara, Jalisco 44600, Mexico
Local Institution, Guadalajara, Jalisco 44680, Mexico
Louisiana Heart Center, Slidell, Louisiana 70458, United States
Local Institution, Winnipeg, Manitoba R3E 3P4, Canada
Local Institution, Morelia, Michioacan 58070, Mexico
Jackson, Danny W., Rolling Fork, Mississippi 39159, United States
Woodlake Research, Chesterfield, Missouri 63017, United States
Nevada Alliance Against Diabetes, Las Vegas, Nevada 89101, United States
Local Institution, Bathurst, New Brunswick E2A 4X7, Canada
Local Institution, Moncton, New Brunswick E1G 1A7, Canada
Slocum-Dickson Medical Group, Pllc, New Hartford, New York 13413, United States
Internist Associates Of Central New York, P. C., Syracuse, New York 13210, United States
Southgate Medical Group, West Seneca, New York 14224, United States
Local Institution, Mount Pearl, Newfoundland and Labrador A1N 1W7, Canada
Local Institution, St-John, Newfoundland and Labrador A1E 2E2, Canada
Local Institution, St. John'S, Newfoundland and Labrador A1A 3R5, Canada
Local Institution, Monterrey, Nuevo Leon 64060, Mexico
Local Institution, Monterrrey, Nuevo Leon 64700, Mexico
Providence Health Partners, Dayton, Ohio 45439, United States
Newark Physician Associates, Newark, Ohio 43055, United States
Physician Research, Inc., Zanesville, Ohio 43701, United States
Gilbert Medical Research, Llc, Bethany, Oklahoma 73008, United States
Integris Family Care Yukon, Yukon, Oklahoma 73109, United States
Local Institution, Oakville, Ontario L6H 3P1, Canada
Local Institution, Sarnia, Ontario N7T 4X3, Canada
Local Institution, Thornhill, Ontario L4J 8L7, Canada
Local Institution, Toronto, Ontario M4R 2G4, Canada
Local Institution, Toronto, Ontario M9W 4L6, Canada
Banksville Medical, Pc, Pittsburgh, Pennsylvania 15216, United States
Local Institution, Charlottetown, Prince Edward Island C1A 5Y9, Canada
Local Institution, Drummondville, Quebec J2B 7T1, Canada
Local Institution, Granby, Quebec J2G 8Z9, Canada
Local Institution, L'Ancienne Lorette, Quebec G2E 2X1, Canada
Local Institution, Mirabel, Quebec J7J 2K8, Canada
Local Institution, St-Leonard, Quebec H1S 3A9, Canada
Local Institution, Saskatoon, Saskatchewan S7K 3H3, Canada
Local Institution, Saskatoon, Saskatchewan S7K 7H9, Canada
Southeastern Research Associates, Inc., Taylors, South Carolina 29687, United States
Holston Medical Group, Kingsport, Tennessee 37660, United States
Village Family Practice, Houston, Texas 77024, United States
Abbott Clinical Research Group, Inc., San Antonio, Texas 78224, United States
Sam Clinical Research Center, San Antonio, Texas 78229, United States
Taylor/Wade Medical, Bountiful, Utah 84010, United States
J. Lewis Research, Inc, Salt Lake City, Utah 84121, United States
Optimum Clinical Research, Inc., Salt Lake City, Utah 84102, United States
Tidewater Integrated Medical Research, Virginia Beach, Virginia 23454, United States
William L. Gray, Md, Spokane, Washington 99216, United States
Local Institution, Merida, Yucatan 97070, Mexico