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Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00316082
First received: April 18, 2006
Last updated: November 20, 2009
Last verified: November 2009
History of Changes
  Purpose

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise


Condition Intervention Phase
Diabetes
 Drug: Saxagliptin
Drug: Placebo
Drug: metformin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1 (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving A1C < 7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]

Enrollment: 365
Study Start Date: June 2006
Study Completion Date: November 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saxagliptin 2.5 mg QAM (A)
PLUS open-label metformin (as needed as rescue medication)
 Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Experimental: Saxagliptin 2.5 mg titrated to 5 mg QAM (B)
PLUS open-label metformin (as needed as rescue medication)
 Drug: Saxagliptin
Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Experimental: Saxagliptin 5 mg QAM (C)
PLUS open-label metformin (as needed as rescue medication)
 Drug: Saxagliptin
Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Experimental: Saxagliptin 5 mg QPM (D)
PLUS open-label metformin (as needed as rescue medication)
 Drug: Saxagliptin
Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT)
Other Name: BMS-477118
Drug: metformin
Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Placebo Comparator: Placebo (E)
PLUS open-label metformin (as needed as rescue medication)
 Drug: Placebo
Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT)
Drug: metformin
Tablets, Oral, 500-2000 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 metformin (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

Exclusion Criteria:

  • Previous treatment for diabetes
  • Current treatment with other medications to lower blood sugar
  • Major heart, liver or kidney problems
  • Women who are pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316082

  Show 74 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb 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: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00316082     History of Changes
Other Study ID Numbers: CV181-038
Study First Received: April 18, 2006
Results First Received: August 17, 2009
Last Updated: November 20, 2009
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
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 May 23, 2013