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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00575588
First received: December 14, 2007
Last updated: March 20, 2012
Last verified: March 2012
History of Changes

December 14, 2007
March 20, 2012
December 2007
August 2009   (final data collection date for primary outcome measure)
Hemoglobin A1c (HbA1c) Change From Baseline to Week 52 [ Time Frame: Baseline to 52 Weeks ] [ Designated as safety issue: No ]
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.
Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c)
Complete list of historical versions of study NCT00575588 on ClinicalTrials.gov Archive Site
  • Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
Safety and tolerability Other secondary measurements of glucose metabolism
Not Provided
Not Provided
 
52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
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.

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • 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
  • Experimental: Saxagliptin
    Interventions:
    • Drug: Metformin
    • Drug: Saxagliptin
  • Experimental: Glipizide
    Interventions:
    • Drug: Metformin
    • Drug: Sulphonylurea

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
891
August 2010
August 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Germany,   Hungary,   India,   Korea, Republic of,   Netherlands,   Norway,   Russian Federation,   Slovakia,   United Kingdom,   Vietnam
 
NCT00575588
D1680C00001, EudraCT number 2007-003998-55
Yes
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Principal Investigator: Burkhard Goke University of Munich, Germany
Study Director: Peter Ohman, MD AstraZeneca
Study Chair: Deborah Price, MSc AstraZeneca
AstraZeneca
March 2012

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