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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: |
NCT00918138 |
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Date of registration:
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09/06/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg
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Scientific title:
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A 4-Week, Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy of Saxagliptin in Combination With Metformin XR 1500 mg Versus Up-titrated Metformin XR to 2000 mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise and a Stable Dose of Metformin XR 1500 mg |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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219 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00918138 |
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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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Israel
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Mexico
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 diabetes
- 18-78 years of age
- Taking stable dose of metformin immediate release (IR) or XR =850 mg and =1500 mg as
monotherapy for at least 8 weeks prior to screening
- Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
- Fasting C-peptide: =1.0 ng/mL
- FPG=126 mg/dl obtained at the Day -7 visit
- Body mass index (BMI): = 40kg/m²
- A1C = 7.0% and = 11.0% obtained at the Day -7 visit for randomization
Exclusion Criteria:
- Women of childbearing potential unable or unwilling to use acceptable birth control
- Women who are pregnant or breastfeeding
- Significant cardiovascular history
- Active liver disease
- Renal impairment
Age minimum:
18 Years
Age maximum:
78 Years
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: Metformin XR
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Drug: Placebo matching Metformin XR
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Drug: Placebo matching Saxagliptin
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Drug: Saxagliptin
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Primary Outcome(s)
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Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
[Time Frame: Baseline, Week 4]
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Secondary Outcome(s)
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Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)
[Time Frame: Baseline, Week 4]
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Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal
[Time Frame: Baseline, Week 4]
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Secondary ID(s)
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CV181-085
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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