Safety and Efficacy Study of Saxagliptin Added to Insulin Alone or to Insulin Taken With Metformin


Tracking Information

Start Date  ICMJENovember 2008
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2008)
Change in A1C level from baseline until Wk 24 (or until the last A1C measured before insulin is up-titrated) [ Time Frame: from baseline until Wk 24 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00757588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: September 22, 2008)
  • The change in the postprandial glucose area under the curve (AUC) in response to a meal tolerance test [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
  • The change in 120-minute postprandial plasma glucose (PPG) response to a meal tolerance test [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
  • The change in fasting plasma glucose (FPG) [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving a therapeutic glycemic response, defined as A1C < 7% [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
  • The change in mean total daily insulin dose [ Time Frame: from baseline to Week 24 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJESafety and Efficacy Study of Saxagliptin Added to Insulin Alone or to Insulin Taken With Metformin
Official Title  ICMJEA Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Brief Summary

The purpose of this study is to compare the effects of saxagliptin versus placebo as add-on therapy to insulin (or to insulin combined with metformin) in improving glycemic control (A1C) at 24 weeks.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEType 2 Diabetes
Intervention  ICMJE
  • Drug: Saxagliptin
    Tablets, Oral, 5 mg, once daily, 24 weeks ST (+28 LT)
    Other Name: BMS-477118
  • Drug: Placebo
    Tablets, Oral, 0 mg, once daily, 24 weeks ST (+28 LT)
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: Saxagliptin
  • 2: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE435
Estimated Completion DateOctober 2010
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥ 18 and ≤ 78 years old
  • Type 2 diabetes
  • Taking stable dose of basal or pre-mixed insulin for at least 8 wks
  • If taking metformin, dose must be stable for ≥ 2 months
  • A1C ≥ 7.5% and ≤ 11.0%
  • BMI ≤ 45 kg/m²
  • Fasting C-peptide ≥ 0.8 ng/mL

Exclusion Criteria:

  • WOCBP unable or unwilling to use acceptable birth control
  • Women who are pregnant or breastfeeding
  • Significant cardiovascular history in last 6 months
  • Active liver disease
  • Renal impairment
  • Anemia
  • Only using short-acting or rapid-acting insulin
GenderBoth
Ages18 Years to 78 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
Location Countries  ICMJEUnited States,   Canada,   France,   Hungary,   India,   Mexico,   Poland,   Russian Federation,   South Africa,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00757588
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECV181-057, Eudract-2008-001089-10
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJEAstraZeneca
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb