A Pilot Study of BMS-512148 in Subjects with Type 2 Diabetes

Study identifier:MB102-009

ClinicalTrials.gov identifier:NCT00357370

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Pilot Study of the Efficacy and Safety of BMS-512148 on Glycemic Control in Subjects with Type 2 Diabetes Treated Aggressively but not Controlled on Combination Antihyperglycemic Therapy with Metformin and/or Thiazolidinedione (TZD) and Insulin.

Medical condition

Type 2 Diabetes

Phase

Phase 2/3

Healthy volunteers

Study drug

Dapagliflozin, Placebo

Sex

All

Actual Enrollment

163

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 01 Oct 2006

Primary Completion Date: 01 Mar 2008

Study Completion Date: 01 Mar 2008

Study design

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

Verification:

Verified 01 Mar 2017 by AstraZeneca Pharmaceuticals

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

Location

University Of Michigan

Ann Arbor, MI, United States, 48109

Location

Diabetes And Glandular Disease Research Associates, P.A.

San Antonio, TX, United States, 78229

Location

Mountain Diabetes And Endocrine Center

Asheville, NC, United States, 28801

Location

Endocrine Research Solutions, Inc.

Roswell, GA, United States, 30076

Location

Valley Research

Fresno, CA, United States, 93720

Location

Bernstein, Richard

Greenbrae, CA, United States, 94904

Location

Indiana University

Indianapolis, IN, United States, 46202

Location

Suny Upstate Medical University

Syracuse, NY, United States, 13210

Arms	Assigned Interventions
Experimental: Cohort 1 20 mg	Drug: Dapagliflozin Tablets, Oral, once daily, up to 12 weeks Other Name: BMS-512148
Experimental: Cohort 2 - Arm 1 10 mg	Drug: Dapagliflozin Tablets, Oral, once daily, up to 12 weeks Other Name: BMS-512148
Experimental: Cohort 2 - Arm 2 20 mg	Drug: Dapagliflozin Tablets, Oral, once daily, up to 12 weeks Other Name: BMS-512148
Placebo Comparator: Cohort 2 - Arm 3	Drug: Placebo Tablets, Oral, 0 mg, once daily, up to 12 weeks

Documents available

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

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

First line of email MUST contain NCT# & Site#. Only trial are recruiting have contact information at this time.

Investigators

Principal Investigator

Bristol-Myers Squibb

A Pilot Study of BMS-512148 in Subjects with Type 2 Diabetes

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

University Of Michigan

Diabetes And Glandular Disease Research Associates, P.A.

Mountain Diabetes And Endocrine Center

Endocrine Research Solutions, Inc.

Valley Research

Bernstein, Richard

Indiana University

Suny Upstate Medical University

Documents available

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

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator