DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Dapagliflozin (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in hemoglobin A1C

Secondary outcome:

Change from baseline in fasting plasma glucose

Change from baseline in the proportion of subjects achieving therapeutic glycemic responses

Change from baseline in the total daily dose of insulin

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic

control

- Subjects receiving insulin and metformin and/or a thiazolidinedione

- Body Mass Index <=45. 0 kg/m2

- Serum creatinine <1. 5 mg/dL for men or <1. 4 mg/dL for women

- No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the

24-hour urinary excretion of total protein must be <3 g/24 hrs) Exclusion Criteria:

- History of type 1 diabetes

- AST and/or ALT >2. 5 times the upper limit of normal

- Creatinine kinase ≥3 times the upper limit of normal

- Symptoms of severely uncontrolled diabetes

- History of hypoglycemic unawareness

- Currently unstable or serious cardiovascular, renal, hepatic, hematological,

oncological, endocrine, psychiatric, or rheumatic diseases

Locations and Contacts

Nea Clinic, Jonesboro, Arkansas 72401, United States

Valley Research, Fresno, California 93720, United States

Bernstein, Richard, Greenbrae, California 94904, United States

Jacksonville Center For Clinical Research, Jacksonville, Florida 32205, United States

Endocrine Research Solutions, Inc., Roswell, Georgia 30076, United States

Indiana University, Indianapolis, Indiana 46202, United States

Local Institution, Winnipeg, Manitoba R3E 3P4, Canada

Model Clinical Research Llc, Baltimore, Maryland 21204, United States

University Of Michigan, Ann Arbor, Michigan 48109, United States

St. Louis Center For Clinical Research, St. Louis, Missouri 63128, United States

Local Institution, Bathurst, New Brunswick E2A 4X7, Canada

Suny Upstate Medical University, Syracuse, New York 13210, United States

Mountain Diabetes And Endocrine Center, Asheville, North Carolina 28801, United States

Your Diabetes Endocrine Nutrition Group, Mentor, Ohio 44060, United States

Local Institution, Gatineau, Quebec J8V 2P5, Canada

Local Institution, Laval, Quebec H7T 2P5, Canada

Local Institution, Longueuil, Quebec J4N 1L6, Canada

Local Institution, Pointe-Claire, Quebec H9R 4S3, Canada

Local Institution, Sherbrooke, Quebec J1G 5K2, Canada

Research Institute Of Dallas, P.A., Dallas, Texas 75231, United States

Diabetes And Glandular Disease Research Associates, P.A., San Antonio, Texas 78229, United States

Rainier Clinical Research Center, Renton, Washington 98055, United States

Advanced Healthcare S.C., Milwaukee, Wisconsin 53209, United States

Additional Information

BMS Clinical Trials Disclosure

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

Starting date: October 2006
Last updated: March 20, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017