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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: |
NCT00316082 |
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Date of registration:
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18/04/2006 |
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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 of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
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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 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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365 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00316082 |
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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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India
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Russian Federation
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Taiwan
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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
- Inadequate blood sugar control
Exclusion Criteria:
- Previous treatment for diabetes
- Current treatment with other medications to lower blood sugar
- Major heart, liver or kidney problems
- Women who are pregnant or breastfeeding
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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Primary Outcome(s)
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Change From Baseline in Hemoglobin A1 (A1C) at Week 24
[Time Frame: Baseline, Week 24]
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Secondary Outcome(s)
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Percentage of Participants Achieving A1C < 7% at Week 24
[Time Frame: Week 24]
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Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
[Time Frame: Baseline, Week 24]
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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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Secondary ID(s)
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CV181-038
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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