A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00295633

Purpose

The purpose of this clinical research study is to learn whether Saxagliptin added to TZD therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Saxagliptin Drug: Placebo	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Saxagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Change in A1C level [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from 0 to 180 minutes for postprandial glucose (PPG) response to an oral glucose tolerance test (OGTT); change in fasting plasma glucose (FPG); proportion of subjects achieving a therapeutic glycemic response (A1C <7.0%) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	555
Study Start Date:	March 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Saxagliptin Tablets, Oral, 2.5 mg, Once daily-AM, 24 weeks.
2: Experimental	Drug: Saxagliptin Tablets, Oral, 5 mg, Once daily-AM, 24 weeks.
3: Placebo Comparator	Drug: Placebo Tablets, Oral, 0mg, Once daily-AM, 24 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 77 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg)for a least 12 weeks prior to screening.
HbA1c > = 7.0% and < = 10.5%
Body mass index < = 45kg/m2
Fasting C-peptide > = 1 ng/mL

Exclusion Criteria:

Symptomatic poorly controlled diabetes
Recent cardiac or cerebrovascular event
Serum creatinine > = 2.0 mg/dL

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295633

Show 133 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CV181-013
Study First Received:	February 22, 2006
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00295633
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
2,4-thiazolidinedione

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009