A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00327015

Purpose

The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets

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:

Mean reduction in baseline A1C values after 24 weeks of treatment [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjects achieving a glycemic response defined as A1C < 7.0% [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
Change from baseline in the fasting plasma glucose [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
Change from baseline in the area under the curve (AUC) for postprandial glucose (PPG) response [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
Subjects requiring rescue for failing to achieve glycemic targets or the need for discontinuation due to lack of efficacy [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
To assess the safety and tolerability of each dose of saxagliptin plus metformin IR, saxagliptin plus placebo and metformin IR plus placebo when administered for up to 24 weeks of short-term double-blind treatment [ Time Frame: up to 24 weeks of short-term double-blind treatment ] [ Designated as safety issue: Yes ]
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 metformin IR, saxagliptin plus placebo and metformin IR plus placebo when administered in the long-term extension phase [ Time Frame: in the long-term extension phase ] [ Designated as safety issue: Yes ]

Enrollment:	1306
Study Start Date:	May 2006
Study Completion Date:	December 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Saxagliptin and Metformin (A): Experimental PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Saxagliptin Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT) Drug: Metformin Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT)
Saxagliptin and Metformin (B): Experimental PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Saxagliptin Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT) Drug: Metformin Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT)
Saxagliptin and Placebo (C): Experimental PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Saxagliptin Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT) Drug: Placebo Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (12 months LT)
Metformin and Placebo (D): Active Comparator PLUS open-label pioglitazone (as needed as rescue medication)	Drug: Metformin Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) Drug: Placebo Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT) Drug: pioglitazone Tablets, Oral, 15-45 mg, as needed (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 pioglitazone (rescue medication) 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
Inadequate blood sugar control
No current treatment with other medications to lower blood sugar

Exclusion Criteria:

Major heart, liver or kidney problems
Pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327015

Show 216 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

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 www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Jadzinsky M, Pfützner A, Paz-Pacheco E, Xu Z, Allen E, Chen R; CV181-039 Investigators. Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diabetes Obes Metab. 2009 Jun;11(6):611-22.

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CV181-039
Study First Received:	May 15, 2006
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00327015 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Pioglitazone
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Pioglitazone
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 September 01, 2009