Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Dapagliflozin

• Registration Number: NCT01165268
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-16
• Study First Posted: 2010-07-19
• Study Start: 2010-08
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin (T2DM)	Dapagliflozin	-
Dapagliflozin (Healthy Subjects)	Dapagliflozin	-

Primary Outcome Measures

Name	Time	Method
The reduction in TmG after 7 days of oral administration of 10 mg of dapagliflozin	After 7 days of oral administration of 10 mg of dapagliflozin

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Profil Institute For Clinical Research, Inc.; 🇺🇸 Chula Vista, California, United States