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52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

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ClinicalTrials.gov Identifier: NCT00575588
Recruitment Status : Completed
First Posted : December 18, 2007
Results First Posted : September 6, 2010
Last Update Posted : March 21, 2012
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE December 14, 2007
First Posted Date  ICMJE December 18, 2007
Results First Submitted Date  ICMJE August 10, 2010
Results First Posted Date  ICMJE September 6, 2010
Last Update Posted Date March 21, 2012
Study Start Date  ICMJE December 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52 [ Time Frame: Baseline to 52 Weeks ]
Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
  • Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks [ Time Frame: From Baseline to Week 52 ]
    Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)
  • Body Weight Change From Baseline to Week 52 [ Time Frame: Baseline, Week 52 (Last Observation Carried Forward) ]
    Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.
  • Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c [ Time Frame: Week 24 to Week 52 ]
    Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2007)
Safety and tolerability Other secondary measurements of glucose metabolism
Current Other Pre-specified Outcome Measures
 (submitted: May 4, 2011)
  • Hemoglobin A1c (HbA1c) Change From Baseline to Week 104 [ Time Frame: Baseline, Week 104 ]
    Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.
  • Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks [ Time Frame: Baseline, Week 104 ]
    Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 104 weeks (Safety Analysis Set)
  • Body Weight Change From Baseline to Week 104 [ Time Frame: Baseline, Week 104 ]
    Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 104. Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 104 value minus the baseline value.
  • Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c [ Time Frame: Week 24 to Week 104 ]
    Mean slopes of regression of change from Week 24 to Week 104 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Full Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
Official Title  ICMJE A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
Brief Summary Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Metformin
    open-label metformin
  • Drug: Sulphonylurea
    Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
  • Drug: Saxagliptin
    Saxagliptin 5 mg tablets
    Other Name: Onglyza
Study Arms  ICMJE
  • Experimental: Saxagliptin
    Interventions:
    • Drug: Metformin
    • Drug: Saxagliptin
  • Experimental: Glipizide
    Interventions:
    • Drug: Metformin
    • Drug: Sulphonylurea
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2010)
891
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2007)
838
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with type 2 diabetes,
  • Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1,
  • HbA1c >6.5% and ≤10.0%

Exclusion Criteria:

  • Type 1 diabetes,
  • history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
  • Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   Germany,   Hungary,   India,   Korea, Republic of,   Netherlands,   Norway,   Russian Federation,   Slovakia,   United Kingdom,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00575588
Other Study ID Numbers  ICMJE D1680C00001
EudraCT number 2007-003998-55
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Burkhard Goke University of Munich, Germany
Study Director: Peter Ohman, MD AstraZeneca
Study Chair: Deborah Price, MSc AstraZeneca
PRS Account AstraZeneca
Verification Date March 2012

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