Diabetes, NOS
Conditions
Brief summary
The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus
Interventions
DRUGDapagliflozin
Tablets, Oral, Once Daily, up to 29 days:
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects * Age 18 to 65 years * BMI 18 to 35 kg/m2 * Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin * No evidence of impaired renal function
Exclusion criteria
* Unwilling or unable to use an acceptable method of birth control * Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B * Exposure to insulin * Use of exclusionary concomitant medications * Evidence of significant kidney disease or any other significant medical or psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in urinary glucose excretion dynamics | after 7 days of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Differences in urinary glucose between healthy and diabetic subjects | at 7 days |
| Changes in liver glucose production | at one day |
| Glucose effects on tubular markers | at one day |
Countries
United States
Outcome results
None listed