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18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)

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ClinicalTrials.gov Identifier: NCT00666458
Recruitment Status : Completed
First Posted : April 25, 2008
Results First Posted : April 15, 2010
Last Update Posted : April 15, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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 sitagliptin in addition with metformin.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: saxagliptin Drug: sitagliptin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 822 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 18-wk, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Comparison With Sitagliptin in Combination With Metformin in Adult Patients With T2D Who Have Inadequate Glycaemic Control on Metformin Alone
Study Start Date : April 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
saxagliptin add-on to metformin
Drug: saxagliptin
tablet, per oral, once daily
Other Name: Onglyza
Active Comparator: 2
sitagliptin add-on to metformin
Drug: sitagliptin
capsule, per oral, once daily
Other Name: Januvia


Outcome Measures

Primary Outcome Measures :
  1. Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 [ Time Frame: Baseline, Week 18 ]
    Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.


Secondary Outcome Measures :
  1. Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 [ Time Frame: Week 18 (Last Observation Carried Forward) ]
    Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set)

  2. Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) [ Time Frame: Baseline, Week 18 (Last Observation Carried Forward) ]
    Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.

  3. Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) [ Time Frame: Baseline, Week 18 (Last Observation Carried Forward) ]
    Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Exclusion Criteria:

  • Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketotic coma
  • Insulin therapy within one year
  • Previous treatment with DPP-4 inhibitor
Contacts and Locations

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): NCT00666458


  Show 86 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Principal Investigator: André Scheen, Professor Clinical Pharmacology Unit, Liege, Belgium
Study Director: Peter Öhman, MD, PhD AstraZeneca, Wilmington, USA
Study Chair: Deborah Price, MSc AstraZeneca, Wilmington, USA
More Information

Responsible Party: Peter Öhman, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00666458     History of Changes
Other Study ID Numbers: D1680C00002
EudraCT number 2007-006095-11
First Posted: April 25, 2008    Key Record Dates
Results First Posted: April 15, 2010
Last Update Posted: April 15, 2010
Last Verified: March 2010

Keywords provided by AstraZeneca:
Type 2 diabetes
metformin

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
Sitagliptin Phosphate
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