Efficacy and Safety Study of Subjects That Are Taking Saxagliptin Added Onto Metformin Immediate Release (IR), Twice Daily, Compared to Subjects Taking Metformin IR Alone

This study is currently recruiting participants.

Verified by Bristol-Myers Squibb, April 2009

First Received: April 21, 2009 Last Updated: August 19, 2009 History of Changes

Sponsors and Collaborators:	Bristol-Myers Squibb AstraZeneca
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00885378

Purpose

The purpose of this study is to compare reduction in A1C for subjects taking saxagliptin and metformin IR versus metformin IR alone.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Saxagliptin plus metformin IR Drug: Placebo plus metformin IR	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination With Metformin IR in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Saxagliptin Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Change in A1C from baseline for saxagliptin 2.5 mg BID (plus stable background metformin IR) vs. placebo (plus stable background metformin IR) [ Time Frame: Week 12 (or last measurement prior if no Week 12 assessment is available) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 12 (or last measurement prior if no Week 12 assessment is available) ] [ Designated as safety issue: No ]
Proportion of subjects with A1C <7.0% [ Time Frame: Week 12 (or last measurement prior if no Week 12 assessment is available) ] [ Designated as safety issue: No ]
Proportion of subjects with A1C ≤6.5% [ Time Frame: Week 12 (or last measurement prior if no Week 12 assessment is available) ] [ Designated as safety issue: No ]

Estimated Enrollment:	152
Study Start Date:	May 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Saxagliptin plus metformin IR: Active Comparator	Drug: Saxagliptin plus metformin IR Tablets, Oral, 2.5 mg, Twice daily, 12 weeks
Placebo plus metformin IR: Placebo Comparator	Drug: Placebo plus metformin IR Tablets, Oral, Placebo, Twice daily, 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes
18-78 years of age
Taking stable BID dosing of metformin IR (at least 1500 mg) for at least 8 weeks
A1C: 7-10%
C-peptide: ≥00.8 ng/mL
BMI: ≤45 kg/m2

Exclusion Criteria:

Women of childbearing potential unable or unwilling to use acceptable birth control
Women who are pregnant or breastfeeding
FPG >270 mg/dL
Significant cardiovascular history
Active liver disease
Renal impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885378

Contacts

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.

Show 40 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

AstraZeneca

Investigators

Study Director:

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: http://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:	CV181-080, EUDRACT #: 2009-010224-25
Study First Received:	April 21, 2009
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00885378 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission; Hungary: National Institute of Pharmacy; Hungary: Medical Research Council Ethic Committee for Clinical Pharmacology (MRC-ECCP); Mexico: Federal Commission for Sanitary Risks Protection; Mexico: Ethics Committee

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

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

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 24, 2009