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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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16 December 2017 |
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Main ID: |
NCT03220425 |
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Date of registration:
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13/07/2017 |
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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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Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.
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Scientific title:
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A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen. |
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Date of first enrolment:
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February 1, 2001 |
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Target sample size:
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752 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03220425 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Belgium
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Denmark
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Finland
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France
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Ireland
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Netherlands
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Norway
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed and dated informed consent obtained before any trial-related activities
- Type 1 diabetes diagnosed and classified according to aetiology
- Duration of type 1 diabetes equal to or more than 12 months
- Glycosylated haemoglobin less than or equal to 12 percent based on analysis from
central laboratory
- Able and willing to perform self-blood glucose monitoring
Exclusion Criteria:
- Proliferative retinopathy
- Total basal insulin dose of more than 100 IU per day
- Recurrent major hypoglycaemia - that would interfere with trial participation (as
judged by the investigator)
- Known unawareness of hypoglycaemia
- Previous treatment with insulin detemir
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 1
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Intervention(s)
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Drug: Insulin detemir
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Drug: NPH insulin
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Primary Outcome(s)
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The change in the level of glycosylated haemoglobin(HbA1c)
[Time Frame: From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)]
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Secondary ID(s)
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NN304-1335
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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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