BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 Diabetes

Study identifier:MB102-072

ClinicalTrials.gov identifier:NCT01498185

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Explore the Safety, Pharmacokinetics and Pharmacodynamics of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus

Medical condition

Type 1 Diabetes Mellitus

Phase

Phase 2

Healthy volunteers

No

Study drug

Dapagliflozin, Placebo matching Dapagliflozin

Sex

All

Actual Enrollment

171

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Feb 2012
Primary Completion Date: 01 Oct 2012
Study Completion Date: 01 Oct 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2016 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Astra Zeneca, Bristol-Myers Squibb

Inclusion and exclusion criteria