Clinical Trials in Russia - Type 2 Diabetes - Clinical Trials in Russia, www.novoclinica.com

Safety and Efficacy Study of Saxagliptin Added to Insulin Alone or to Insulin Taken With Metformin

Start Date ^ICMJE	November 2008
Estimated Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 22, 2008)	Change in A1C level from baseline until Wk 24 (or until the last A1C measured before insulin is up-titrated) [ Time Frame: from baseline until Wk 24 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00757588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 22, 2008)	The change in the postprandial glucose area under the curve (AUC) in response to a meal tolerance test [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ] The change in 120-minute postprandial plasma glucose (PPG) response to a meal tolerance test [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ] The change in fasting plasma glucose (FPG) [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ] The proportion of subjects achieving a therapeutic glycemic response, defined as A1C < 7% [ Time Frame: at Week 24 ] [ Designated as safety issue: No ] The change in mean total daily insulin dose [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Brief Title ^ICMJE	Safety and Efficacy Study of Saxagliptin Added to Insulin Alone or to Insulin Taken With Metformin
Official Title ^ICMJE	A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Brief Summary	The purpose of this study is to compare the effects of saxagliptin versus placebo as add-on therapy to insulin (or to insulin combined with metformin) in improving glycemic control (A1C) at 24 weeks.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Drug: Saxagliptin Tablets, Oral, 5 mg, once daily, 24 weeks ST (+28 LT) Other Name: BMS-477118 Drug: Placebo Tablets, Oral, 0 mg, once daily, 24 weeks ST (+28 LT)
Study Arms / Comparison Groups	1: Experimental Intervention: Drug: Saxagliptin 2: Placebo Comparator Intervention: Drug: Placebo

Estimated Enrollment ^ICMJE

435

Estimated Completion Date

October 2010

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Exclusion Criteria:

Gender

Both

Ages

18 Years to 78 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Location Countries ^ICMJE

United States, Canada, France, Hungary, India, Mexico, Poland, Russian Federation, South Africa, United Kingdom

NCT ID ^ICMJE

NCT00757588

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

CV181-057, Eudract-2008-001089-10

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb