Renal Mechanism of Action/Splay vs. TmG

Phase 1

Terminated

• Conditions: Diabetes, NOS
• Interventions: Drug: Dapagliflozin

• Registration Number: NCT00726505
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-08-01
• Study Start: 2009-06
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Dapagliflozin	Subjects with T2DM - Dapagliflozin 5 mg
Group 2	Dapagliflozin	Subjects with T2DM - Dapagliflozin 20 mg
Group 3	Dapagliflozin	Healthy Subjects - Dapagliflozin 20 mg

Primary Outcome Measures

Name	Time	Method
The change in urinary glucose excretion dynamics	after 7 days of treatment

Secondary Outcome Measures

Name	Time	Method
Glucose effects on tubular markers	at one day
Differences in urinary glucose between healthy and diabetic subjects	at 7 days
Changes in liver glucose production	at one day

Trial Locations

Locations (1)

University Of Texas Health Center At San Antonio; 🇺🇸 San Antonio, Texas, United States