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

Type 2 Diabetes Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357370
• Other study ID #: MB102-009
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 26, 2006
• Last updated: March 20, 2015
• Start date: October 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
• Placebo
Tablets, Oral, 0 mg, once daily, up to 12 weeks

Locations

Country	Name	City	State
Canada	Local Institution	Bathurst	New Brunswick
Canada	Local Institution	Gatineau	Quebec
Canada	Local Institution	Laval	Quebec
Canada	Local Institution	Longueuil	Quebec
Canada	Local Institution	Pointe-Claire	Quebec
Canada	Local Institution	Sherbrooke	Quebec
Canada	Local Institution	Winnipeg	Manitoba
United States	University Of Michigan	Ann Arbor	Michigan
United States	Mountain Diabetes And Endocrine Center	Asheville	North Carolina
United States	Model Clinical Research Llc	Baltimore	Maryland
United States	Research Institute Of Dallas, P.A.	Dallas	Texas
United States	Valley Research	Fresno	California
United States	Bernstein, Richard	Greenbrae	California
United States	Indiana University	Indianapolis	Indiana
United States	Jacksonville Center For Clinical Research	Jacksonville	Florida
United States	Nea Clinic	Jonesboro	Arkansas
United States	Your Diabetes Endocrine Nutrition Group	Mentor	Ohio
United States	Advanced Healthcare S.C.	Milwaukee	Wisconsin
United States	Rainier Clinical Research Center	Renton	Washington
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	Diabetes And Glandular Disease Research Associates, P.A.	San Antonio	Texas
United States	St. Louis Center For Clinical Research	St. Louis	Missouri
United States	Suny Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Wilding JP, Norwood P, T'joen C, Bastien A, List JF, Fiedorek FT. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment. Diabetes Care. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hemoglobin A1C		at Week 12	No
Secondary	Change from baseline in fasting plasma glucose		at Week 12	No
Secondary	Change from baseline in the proportion of subjects achieving therapeutic glycemic responses		at Week 12	No
Secondary	Change from baseline in the total daily dose of insulin		at Week 12	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm