Renal Impairment in Type 2 Diabetic Subjects

Study identifier:MB102-007

ClinicalTrials.gov identifier:NCT00554450

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

The Pharmacodynamics, Pharmacokinetics, and Safety of Dapagliflozin in Type 2 Diabetic Subjects with Mild, Moderate, and Severe Renal Impairment

Medical condition

Diabetes Mellitus, Type 2

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Dapagliflozin

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 79 Years

Date

Study Start Date: 01 Mar 2006

Primary Completion Date: 01 Oct 2008

Study Completion Date: 01 Oct 2008

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2016 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: Arm 1 50 mg single dose	Drug: Dapagliflozin Tablets, Oral, once daily
Experimental: Arm 2 20 mg up to 7 days	Drug: Dapagliflozin Tablets, Oral, once daily

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
MB102007 _Redacted _CSR _synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator