A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00313313

Purpose

The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

Condition	Intervention	Phase
Diabetes	Drug: Saxagliptin Drug: Glyburide Drug: Placebo Drug: Metformin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glyburide Saxagliptin Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Change From Baseline in Hemoglobin A1c (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Mean change from baseline in A1C at Week 24, adjusted for baseline value.

Secondary Outcome Measures:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Percentage of Participants Achieving A1C < 7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.

Enrollment:	768
Study Start Date:	April 2006
Study Completion Date:	September 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Saxagliptin 2.5 mg + Glyburide 7.5 mg (A) Metformin 500-2500 mg (as needed)	Drug: Saxagliptin Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT]) Other Name: BMS-477118 Drug: Glyburide Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT) Drug: Metformin Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Experimental: Saxagliptin 5 mg + Glyburide 7.5 mg (B) Metformin 500-2500 mg (as needed)	Drug: Saxagliptin Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT). Other Name: BMS-477118 Drug: Glyburide Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT) Drug: Metformin Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)
Placebo Comparator: Placebo + Glyburide 7.5 mg (C) Metformin 500-2500 mg (as needed)	Drug: Placebo Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT) Drug: Glyburide Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT) Drug: Metformin Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Detailed Description:

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Eligibility

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

Criteria

Inclusion Criteria:

Type 2 Diabetes.
Treated with a sulfonylurea for at least 2 months.
Inadequate blood sugar control.
Are not on any other medications to lower blood sugar.
No major heart, liver or kidney problems.
Women not pregnant or breast feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313313

Show 115 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional 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

Publications:

Chacra AR, Tan GH, Apanovitch A, Ravichandran S, List J, Chen R; CV181-040 Investigators. Saxagliptin added to a submaximal dose of sulphonylurea improves glycaemic control compared with uptitration of sulphonylurea in patients with type 2 diabetes: a randomised controlled trial. Int J Clin Pract. 2009 Sep;63(9):1395-406. Epub 2009 Jul 15.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Karyekar C, Donovan M, Allen E, Fleming D, Ravichandran S, Chen R. Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. Postgrad Med. 2011 Jul;123(4):63-70.

Chacra AR, Tan GH, Ravichandran S, List J, Chen R; CV181040 Investigators. Safety and efficacy of saxagliptin in combination with submaximal sulphonylurea versus up-titrated sulphonylurea over 76 weeks. Diab Vasc Dis Res. 2011 Apr;8(2):150-9.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00313313 History of Changes
Other Study ID Numbers:	CV181-040
Study First Received:	April 10, 2006
Results First Received:	August 17, 2009
Last Updated:	August 4, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Glyburide
Metformin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012