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A Study Assessing 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:
NCT00374907
First received: September 7, 2006
Last updated: June 3, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes


Condition Intervention Phase
Type 2 Diabetes
 Drug: Saxagliptin
Drug: Placebo
Drug: Metformin (blinded)
Drug: Metformin (open-label)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Mechanism of Action and Efficacy of Saxagliptin (BMS-477118) in the Treatment of Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load [intravenous-oral hyperglycemic clamp (180-480 minutes)] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.


Secondary Outcome Measures:
  • Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.


Enrollment: 156
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saxagliptin (A)
Metformin 500-1500 mg (open-label, as needed for rescue in LT)
 Drug: Saxagliptin
Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)
Other Name: BMS-477118
Placebo Comparator: Placebo (ST) / Metformin (LT) (B)
Metformin 500-1500 mg (open-label, as needed for rescue in LT)
 Drug: Placebo
Tablet, Oral, 0 mg, Once daily (up to 12 weeks ST)
Drug: Metformin (blinded)
Tablet, Oral, 500 mg titrated to 1000 mg, Once daily (up to 104 weeks LT, starting at Week 12)
Drug: Metformin (open-label)
Tablets, Oral, 500-1500 mg, as needed (starting in 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 who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Drug naive
  • Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
  • Fasting C-peptide ≥1.0 ng/mL
  • Body mass index ≤40 kg/m²

Exclusion Criteria:

  • Recent cardiac or cerebrovascular event
  • Elevated serum creatinine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374907

Locations
United States, California
Va San Diego Healthcare System
San Diego, California, United States, 92161
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
United States, Texas
Diabetes & Glandular Disease Research Assoc,, Inc.
San Antonio, Texas, United States, 78229
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: NCT00374907     History of Changes
Other Study ID Numbers: CV181-041
Study First Received: September 7, 2006
Results First Received: December 26, 2010
Last Updated: June 3, 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 May 19, 2013