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

September 7, 2006
June 3, 2011
September 2006
January 2008   (final data collection date for primary outcome measure)
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.
Insulin at 12 week
Complete list of historical versions of study NCT00374907 on ClinicalTrials.gov Archive Site
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.
  • Other measures of insulin secretion at 12 weeks
  • Levels of other hormones that affect blood sugar levels at 12 weeks
Not Provided
Not Provided
 
A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Mechanism of Action and Efficacy of Saxagliptin (BMS-477118) in the Treatment of Type 2 Diabetic Patients

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Saxagliptin
    Tablet, Oral, 5 mg, Once daily, (up to 12 weeks ST, up to 104 weeks LT)
    Other Name: BMS-477118
  • 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)
  • Experimental: Saxagliptin (A)
    Metformin 500-1500 mg (open-label, as needed for rescue in LT)
    Intervention: Drug: Saxagliptin
  • Placebo Comparator: Placebo (ST) / Metformin (LT) (B)
    Metformin 500-1500 mg (open-label, as needed for rescue in LT)
    Interventions:
    • Drug: Placebo
    • Drug: Metformin (blinded)
    • Drug: Metformin (open-label)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
December 2009
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00374907
CV181-041
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP