NCT00538174
Completed
Phase 1
A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects
Overview
- Phase
- Phase 1
- Intervention
- Dapagliflozin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- AstraZeneca
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Clinical labs
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm 1
2.5 mg
Intervention: Dapagliflozin
Arm 2
10 mg
Intervention: Dapagliflozin
Arm 3
20 mg
Intervention: Dapagliflozin
Arm 4
Intervention: placebo
Outcomes
Primary Outcomes
Clinical labs
Time Frame: scr, Days -1, 2, 7, 12, 14, 15, 21
Urine safety markers
Time Frame: Days -1, 1, 14
AEs, vital signs & physical exam
Time Frame: scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21
ECGs
Time Frame: scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21
Secondary Outcomes
- Serum glucose, serum insulin, serum c-peptide(Days -1, 1, 14)
- 24h urine(Days -1, 1 & 14 for glucose, creatinine & calcium)
- 24 hr PK blood & urine samples(Days 1 & 14)
- Serum fructosamine(Days -1, 14, 4 h)
- OGTT(Days -2, 13 (after 10 h fast))
Study Sites (1)
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