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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00666458 |
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Date of registration:
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23/04/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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822 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00666458 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Belgium
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Brazil
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Denmark
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France
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Italy
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Mexico
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Norway
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South Africa
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Sweden
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Contacts
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Name:
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André Scheen, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinical Pharmacology Unit, Liege, Belgium |
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Name:
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Deborah Price, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca, Wilmington, USA |
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Name:
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Peter Öhman, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca, Wilmington, USA |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Intervention(s)
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Drug: saxagliptin
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Drug: sitagliptin
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Primary Outcome(s)
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Hemoglobin A1c (HbA1c) Change From Baseline to Week 18
[Time Frame: Baseline, Week 18]
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Secondary Outcome(s)
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Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL)
[Time Frame: Baseline, Week 18 (Last Observation Carried Forward)]
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Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18
[Time Frame: Week 18 (Last Observation Carried Forward)]
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Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L)
[Time Frame: Baseline, Week 18 (Last Observation Carried Forward)]
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Secondary ID(s)
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EudraCT number 2007-006095-11
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D1680C00002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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