Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

AstraZeneca1 site in 1 country1 target enrollmentJune 2009

ConditionsDiabetes, NOS

InterventionsDapagliflozin

DrugsDapagliflozin

Overview

Phase: Phase 1
Intervention: Dapagliflozin
Conditions: Diabetes, NOS
Sponsor: AstraZeneca
Enrollment: 1
Locations: 1
Primary Endpoint: The change in urinary glucose excretion dynamics
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

August 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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