Renal Mechanism of Action/Splay vs. TmG

Diabetes, NOS Clinical Trial

— MOA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00726505
• Other study ID #: MB102-020
• Status: Terminated
• Phase: Phase 1
• First received: July 30, 2008
• Last updated: October 14, 2016
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes, NOS

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, Once Daily, up to 29 days:

Locations

Country	Name	City	State
United States	University Of Texas Health Center At San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in urinary glucose excretion dynamics		after 7 days of treatment	No
Secondary	Differences in urinary glucose between healthy and diabetic subjects		at 7 days	No
Secondary	Changes in liver glucose production		at one day	No
Secondary	Glucose effects on tubular markers		at one day	No

External Links

•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   MB102020 _Redacted _CSR _synopsis