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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: |
NCT00960076 |
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Date of registration:
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14/08/2009 |
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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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An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes
SCORE |
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Scientific title:
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18-Week, Multicenter, Randomized, Double-Blind 3b Trial to Evaluate Efficacy/Safety of Saxagliptin in Combo With Metformin XR 1500mg vs Metformin Uptitrated to 2000mg in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control After Diet/Exercise and a Stable Dose of Metformin XR 1500mg |
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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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282 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00960076 |
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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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Colombia
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Costa Rica
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Mexico
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Peru
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United States
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Contacts
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Name:
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Vivian Fonseca, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tulane University |
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Name:
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Boaz Hirschberg, MD |
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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 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less
than or equal to 1500mg only for at least 8 weeks prior to screening
- A1c: 7.5-11% (at screening)
- BMI less than or equal to 45 kg/m2
Exclusion Criteria:
- 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: Saxagliptin
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Primary Outcome(s)
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Change in HbA1c Level From Baseline to Week 18 (LOCF)
[Time Frame: Baseline to week 18]
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Secondary Outcome(s)
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Change in FPG From Baseline to Week 18 (LOCF)
[Time Frame: Baseline to week 18]
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Change in 2-hour PPG Following Mixed Meal Tolerance Test (MMTT) From Baseline to Week 18 (LOCF)
[Time Frame: Baseline to week 18]
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Percent of Subjects Reaching Goal (HbA1c <7%) at Week 18 (LOCF) - Percent of Subjects (1)
[Time Frame: Week 18 (LOCF)]
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Secondary ID(s)
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D1680L00005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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