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

Sponsored by:	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

MedlinePlus related topics: Diabetes

Drug Information available for: Glyburide Saxagliptin Metformin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Change in baseline A1C value [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in area under the curve for postprandial glucose response to an oral glucose tolerance test [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
Change from baseline in fasting plasma glucose [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
To assess the safety and tolerability of each dose of saxagliptin plus glyburide when administered for up to 24 weeks of short-term double-blind therapy [ Time Frame: up to 24 weeks of short-term double-blind therapy ] [ Designated as safety issue: Yes ]
Proportion of subjects achieving A1C < 7% [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
To assess for each saxagliptin treatment group the glycemic parameters in the long-term extension [ Time Frame: in the long-term extension ] [ Designated as safety issue: No ]
To assess the safety and tolerability of each dose of saxagliptin plus glyburide and each dose of saxagliptin plus glyburide plus metformin in the long-term extension period [ Time Frame: in the long-term extension period ] [ Designated as safety issue: Yes ]

Enrollment:	780
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
Saxagliptin 2.5 mg + Glyburide 7.5 mg (A): Experimental Metformin 500-2500 mg (as needed)	Drug: Saxagliptin Tablets, Oral, 2.5 mg, Daily AM, (24 weeks ST, 12 months LT) 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)
Saxagliptin 5 mg + Glyburide 7.5 mg (B): Experimental Metformin 500-2500 mg (as needed)	Drug: Saxagliptin Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT). 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 + Glyburide 7.5 mg (C): Active Comparator 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 will be eligible to enter the long-term treatment extension period where they will receive metformin

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.
Age 18-77
Male or female
Women not pregnant or breast feeding.

Contacts and Locations

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

Show 120 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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CV181-040
Study First Received:	April 10, 2006
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00313313 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glyburide
Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Glyburide
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009