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 country24 target enrollmentAugust 2010

ConditionsType 2 Diabetes Mellitus

InterventionsDapagliflozin

Overview

Phase: Phase 1
Intervention: Dapagliflozin
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Enrollment: 24
Locations: 1
Primary Endpoint: The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

It is anticipated that 7 days of oral administration of 10 mg dapagliflozin will reduce the renal glucose reabsorption similarly in healthy subjects and in subjects with T2DM.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

December 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Dapagliflozin (T2DM)

Intervention: Dapagliflozin

Dapagliflozin (Healthy Subjects)

Intervention: Dapagliflozin

Outcomes

Primary Outcomes

The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin

Time Frame: After 7 days of oral administration of 10 mg of dapagliflozin

Secondary Outcomes

Splay of the glucose titration curve(After 7 days of oral administration of 10 mg of dapagliflozin)
Pharmacokinetics (Cmin, Cmax, Tmax, and AUC (TAU)) of dapagliflozin(Study Day 8)