Phase I Multiple-Ascending Dose (Japan)
- Registration Number
- NCT00538174
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Japanese male and female subjects
- Ages 20 to 70 years old
- Established diagnosis of T2DM
- BMI < 32 kg/m2
- Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone
- HbA1C 6.0 - 10.0%
Exclusion Criteria
- Symptomatic T2DM defined as polyuria and/or polydipsia within 2 months of enrollment
- History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
- History of incontinence or bladder dysfunction including nocturia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 4 placebo - Arm 1 Dapagliflozin 2.5 mg Arm 3 Dapagliflozin 20 mg Arm 2 Dapagliflozin 10 mg
- Primary Outcome Measures
Name Time Method Clinical labs scr, Days -1, 2, 7, 12, 14, 15, 21 Urine safety markers Days -1, 1, 14 AEs, vital signs & physical exam scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21 ECGs scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21
- Secondary Outcome Measures
Name Time Method 24h urine Days -1, 1 & 14 for glucose, creatinine & calcium Serum glucose, serum insulin, serum c-peptide Days -1, 1, 14 24 hr PK blood & urine samples Days 1 & 14 Serum fructosamine Days -1, 14, 4 h OGTT Days -2, 13 (after 10 h fast)
Trial Locations
- Locations (1)
Local Institution
🇯🇵Suita, Osaka, Japan