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Saxagliptin Treatment 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:
NCT00121641
First received: July 15, 2005
Last updated: August 5, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Saxagliptin
Drug: Placebo matching Saxagliptin
Drug: Metformin
Drug: Placebo matching Metformin
 Phase 3

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 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy 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:
  • Hemoglobin A1c (A1C) Changes From Baseline at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.

  • A1C Changes From Baseline at Week 24 - Open Label Cohort [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.


Secondary Outcome Measures:
  • Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • 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 ]
  • Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort [ 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) - Open Label Cohort [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]

Enrollment: 1035
Study Start Date: July 2005
Study Completion Date: February 2010
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saxagliptin 2.5 mg (A)
Metformin 500-2000 mg (as needed for rescue)
 Drug: Saxagliptin
Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT])
Other Name: BMS-477118
Drug: Placebo matching Metformin
Tablets, Oral, 0 mg, daily (42 months LT)
Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue)
Experimental: Saxagliptin 5 mg (B)
Metformin 500-2000 mg (as needed for rescue)
 Drug: Saxagliptin
Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT)
Other Name: BMS-477118
Drug: Placebo matching Metformin
Tablets, Oral, 0 mg, daily (42 months LT)
Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue)
Experimental: Saxagliptin 10 mg (C)
Metformin 500-2000 mg (as needed for rescue)
 Drug: Saxagliptin
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT)
Other Name: BMS-477118
Drug: Placebo matching Metformin
Tablets, Oral, 0 mg, daily (42 months LT)
Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue)
Placebo Comparator: Placebo (D)
Metformin 500-2000 mg (as needed for rescue)
 Drug: Placebo matching Saxagliptin
Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT)
Drug: Metformin
Tablets, Oral, 500 mg, daily (42 months LT)
Drug: Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue)
Experimental: Open-Label Treatment Cohort (Direct Enrollees) (E)

Saxagliptin 10 mg

Metformin 500-2000 mg (as needed for rescue)

 Drug: Saxagliptin
Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label
Other Name: BMS-477118
Drug: Metformin
Tablets, Oral, 500-2000 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 metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) > 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.

  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
  • Drug naive
  • Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)
  • Fasting C-peptide >= 1 ng/mL
  • Body mass index <= 40 kg/m2

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 Women of Child Bearing Potential
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121641

  Show 135 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:

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00121641     History of Changes
Other Study ID Numbers: CV181-011
Study First Received: July 15, 2005
Results First Received: April 12, 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
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 October 16, 2012