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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Metformin Drug: Sulphonylurea Drug: Saxagliptin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 891 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : December 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Saxagliptin Drug: Metformin
open-label metformin

Drug: Saxagliptin
Saxagliptin 5 mg tablets
Other Name: Onglyza
Experimental: Glipizide Drug: Metformin
open-label metformin

Drug: Sulphonylurea
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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)

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575588


Locations
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Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
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Principal Investigator: Burkhard Goke University of Munich, Germany
Study Director: Peter Ohman, MD AstraZeneca
Study Chair: Deborah Price, MSc AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00575588    
Other Study ID Numbers: D1680C00001
EudraCT number 2007-003998-55
First Posted: December 18, 2007    Key Record Dates
Results First Posted: September 6, 2010
Last Update Posted: March 21, 2012
Last Verified: March 2012
Keywords provided by AstraZeneca:
DPP-4 Inhibitors
HbA1c
incretins
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Saxagliptin
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action