A Trial of BMS-512148 in Patients with Type 2 Diabetes Mellitus

Study identifier:MB102-008

ClinicalTrials.gov identifier:NCT00263276

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise

Medical condition

Type 2 Diabetes

Phase

Phase 2

Healthy volunteers

Study drug

dapagliflozin, placebo, metformin

Sex

All

Actual Enrollment

389

Study type

Interventional

Age

18 Years - 79 Years

Date

Study Start Date: 01 Dec 2005

Primary Completion Date: 01 Feb 2007

Study Completion Date: 01 Feb 2007

Study design

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

Verification:

Verified 01 Nov 2016 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

Location

Local Institution

Calgary, AB, Canada

Location

Local Institution

Vancouver, BC, Canada

Location

Local Institution

Winnipeg, MB, Canada

Location

Local institution

Bathurst, NB, Canada

Location

Local Institution

Moncton, NB, Canada

Location

Local Institution

St. John's, NB, Canada

Location

Local Institution

Toronto, ON, Canada

Location

Local Institution

Drummondville, QC, Canada

Arms	Assigned Interventions
Experimental: Arm 1	Drug: dapagliflozin Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
Experimental: Arm 2	Drug: dapagliflozin Tablets, Oral, 5 mg, Once daily, 12 weeks.
Experimental: Arm 3	Drug: dapagliflozin Tablets, Oral, 10 mg, Once daily, 12 weeks.
Experimental: Arm 4	Drug: dapagliflozin Tablets, Oral, 20 mg, Once daily, 12 weeks.
Experimental: Arm 5	Drug: dapagliflozin Tablets, Oral, 50 mg, Once daily, 12 weeks.
Placebo Comparator: Arm 6	Drug: placebo Tablets, Oral, 0 mg, Once daily, 12 weeks.
Active Comparator: Arm 7	Drug: metformin Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.

"There is no result for the study"

Documents available

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Download
MB102-008 _CSR_synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Bristol Myers Squibb

A Trial of BMS-512148 in Patients with Type 2 Diabetes Mellitus

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Local Institution

Local Institution

Local Institution

Local institution

Local Institution

Local Institution

Local Institution

Local Institution

Documents available

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

MB102-008 _CSR_synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator