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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: |
NCT00313313 |
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Date of registration:
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10/04/2006 |
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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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A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas
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Scientific title:
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A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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768 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00313313 |
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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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Brazil
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Hong Kong
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Israel
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Korea, Republic of
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Mexico
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Peru
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Philippines
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Puerto Rico
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Singapore
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South Africa
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Taiwan
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Thailand
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 Diabetes.
- Treated with a sulfonylurea for at least 2 months.
- Inadequate blood sugar control.
- Are not on any other medications to lower blood sugar.
- No major heart, liver or kidney problems.
- Women not pregnant or breast feeding.
Age minimum:
18 Years
Age maximum:
77 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes
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Intervention(s)
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Drug: Placebo
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Drug: Saxagliptin
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Drug: Metformin
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Drug: Glyburide
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Primary Outcome(s)
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Change From Baseline in Hemoglobin A1c (A1C) at Week 24
[Time Frame: Baseline, Week 24]
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Secondary Outcome(s)
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Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
[Time Frame: Baseline, Week 24]
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Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
[Time Frame: Baseline, Week 24]
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Percentage of Participants Achieving A1C < 7% at Week 24
[Time Frame: Week 24]
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Secondary ID(s)
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CV181-040
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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