Diabetes Mellitus, Type 2
Conditions
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
Interventions
DRUGplacebo
Tablets, Oral, 0 mg, once daily, up to 14 days
DRUGDapagliflozin
Tablets, Oral, once daily up, to 14 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Clinical labs | scr, Days -1, 2, 7, 12, 14, 15, 21 |
| Urine safety markers | Days -1, 1, 14 |
Secondary
| Measure | Time frame |
|---|---|
| 24 hr PK blood & urine samples | Days 1 & 14 |
| 24h urine | Days -1, 1 & 14 for glucose, creatinine & calcium |
| Serum glucose, serum insulin, serum c-peptide | Days -1, 1, 14 |
| Serum fructosamine | Days -1, 14, 4 h |
| OGTT | Days -2, 13 (after 10 h fast) |
Countries
Japan
Outcome results
None listed