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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 February 2015 |
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Main ID: |
NCT00993720 |
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Date of registration:
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09/10/2009 |
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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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Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes
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Scientific title:
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Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00993720 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Denmark
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age 18-50y,
- BMI 18-27,
- caucasian origin,
- type 1 diabetes diagnosed between age 5 and age 40,
- no known diabetes complications or cardiovascular diseases,
- no medication known to influence glucose homeostasis,
- no pregnancy
Exclusion Criteria:
- diabetes complications,
- autonomous nerve dysfunction,
- anaemia,
- HbA1c < 8.5% at screening,
- estimated by the investigator to be incapable of completing the trial.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Intervention(s)
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Drug: Liraglutide
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Other: continuous insulin therapy
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Primary Outcome(s)
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insulin-dose
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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24-hours glucose profiles with and without treatment of Victoza
[Time Frame: three days]
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weight change from baseline, change in fructosamine from baseline
[Time Frame: four weeks]
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risk of hypoglycemia during physical activity with and without Victoza
[Time Frame: one day]
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gastric emptying rate during hypoglycemia with and without Victoza
[Time Frame: one day]
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Secondary ID(s)
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2009-001930-80
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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