Renal Mechanism of Action/Splay vs. TmG - MOA

Study identifier:MB102-020

ClinicalTrials.gov identifier:NCT00726505

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

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

Medical condition

Diabetes, NOS

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Dapagliflozin

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Jun 2009

Primary Completion Date: 01 Aug 2009

Study Completion Date: 01 Aug 2009

Study design

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

Verification:

Verified 01 Oct 2016 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

Location

University Of Texas Health Center At San Antonio

San Antonio, TX, United States, 78229

Arms	Assigned Interventions
Active Comparator: Group 1 Subjects with T2DM - Dapagliflozin 5 mg	Drug: Dapagliflozin Tablets, Oral, Once Daily, up to 29 days: Other Name: BMS-512148
Active Comparator: Group 2 Subjects with T2DM - Dapagliflozin 20 mg	Drug: Dapagliflozin Tablets, Oral, Once Daily, up to 29 days: Other Name: BMS-512148
Active Comparator: Group 3 Healthy Subjects - Dapagliflozin 20 mg	Drug: Dapagliflozin Tablets, Oral, Once Daily, up to 29 days: Other Name: BMS-512148

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
MB102020 _Redacted _CSR _synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator