Health Condition 1: null- Type 2 Diabetes
Conditions
Interventions
Intervention1: Dapagliflozin: Tablets, Oral, 2.5 mg QD, once daily, up to
12 weeks
Intervention2: Dapagliflozin: Tablets, Oral, 5 mg QD, once daily, up to 12 weeks
Intervention3: Dapagliflozin: Table
Sponsors
BristolMyers Squibb India pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Ages Eligible for Study:18 Years to 89 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Males and females, 18 to 89 years old, with type 2 diabetes with inadequate, glycemic control HbA1c between 7-10% and uncontrolled hypertension SBP 140-165 and DBP 85-105. Stable dose of oral antidiabetic agent (OAD) for 6 weeks (12 wks for TZD) and a stable dose of ACEI or ARB for 4 weeks. C-peptide >= 0.8 ng/mL Body Mass Index Serum Creatinine (SCr) more than or equal to 2.0 mg/dL unless subject is on metformin then the exclusionary limits will be SCr more than or equal to 1.50 mg/dL (133 mmol/L) for male subjects; SCr more than or equal to 1.40 mg/dL (124 mmol/L) for female subjects
Exclusion criteria
Exclusion criteria: AST and /or ALT 3.0 times the upper limit of normal (ULN) Serum total bilirubin 1.5 X ULN Creatinine kinase 3 X ULN Symptoms of severely uncontrolled diabetes History of malignant or accelerated hypertension Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in seated systolic blood pressure [ Time Frame: Baseline and after 12 weeks ]To compare change from baseline in HbA1c after week 12 of double-blind treatmentTimepoint: Baseline & Week 12 after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in 24-hr ambulatory systolic blood pressureTimepoint: Baseline & After 12 weeks;Change in 24-hr ambulatory diastolic blood pressureTimepoint: Baseline & After 12 weeks;Change in serum uric acidTimepoint: Baseline and after 12 weeks | — |
Countries
Canada, Colombia, Germany, Hungary, India, Mexico, Poland, Russian Federation, Spain, United States of America
Contacts
Public ContactSubashri Shivkumar
Outcome results
None listed