Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00121667

Purpose

The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Saxagliptin + Metformin Drug: Placebo + Metformin Drug: Pioglitazone	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 III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin 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: Pioglitazone Pioglitazone hydrochloride Saxagliptin Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Baseline and 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 is adjusted for baseline value.
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
Mean change from baseline is adjusted for baseline value.

Enrollment:	1462
Study Start Date:	August 2005
Study Completion Date:	February 2010
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Saxagliptin + Metformin (A) Pioglitazone 15-45 mg (as needed for rescue)	Drug: Saxagliptin + Metformin Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue)
Experimental: Saxagliptin + Metformin (B) Pioglitazone 15-45 mg (as needed for rescue)	Drug: Saxagliptin + Metformin Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue)
Experimental: Saxagliptin + Metformin (C) Pioglitazone 15-45 mg (as needed for rescue)	Drug: Saxagliptin + Metformin Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Name: BMS-477118 Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue)
Placebo Comparator: Placebo+ Metformin (D) Pioglitazone 15-45 mg (as needed for rescue)	Drug: Placebo + Metformin Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT) Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue)

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 pioglitizone added onto their blinded study medication

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 mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
HbA1c >= 7.0% and <= 10.0 %
Body mass index <= 40 kg/m2
Fasting C-peptide >= 1 ng/dL

Exclusion Criteria:

Symptomatic poorly controlled diabetes
Recent cardiac or cerebrovascular event
Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121667

Show 154 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:

DeFronzo RA, Hissa MN, Garber AJ, Luiz Gross J, Yuyan Duan R, Ravichandran S, Chen RS; Saxagliptin 014 Study Group. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes with metformin alone. Diabetes Care. 2009 Sep;32(9):1649-55. Epub 2009 May 28.

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.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00121667 History of Changes
Other Study ID Numbers:	CV181-014
Study First Received:	July 18, 2005
Results First Received:	March 15, 2011
Last Updated:	August 5, 2011
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
Pioglitazone
Saxagliptin
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