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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00841087 |
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Date of registration:
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10/02/2009 |
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Primary sponsor: |
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Public title:
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Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes
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Scientific title:
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Safety (With Emphasis on Hypoglycaemia) Comparison of NN1250 Versus Insulin Detemir All in a Basal-bolus Regimen in Subjects With Type 1 Diabetes Mellitus After 6 Weeks of Treatment. |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00841087 |
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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: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Michiaki Kanai |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk Pharma Ltd. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with type 1 diabetes mellitus more than one year
- Current treatment: basal (once daily at bedtime) - bolus (three times a day just
before main meals) regimen only at least 12 weeks, using a long-acting insulin
analogue or intermediate-acting insulin as a basal insulin and insulin aspart as
bolus insulin
- HbA1C below 10.0%
Exclusion Criteria:
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- Current treatment with total insulin dose of more than 100 U or IU/day
- Current treatment or expected to start treatment with systemic corticosteroid
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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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 aspart
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Drug: insulin detemir
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Drug: NN1250
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Primary Outcome(s)
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The incidence of hypoglycaemic episodes during the 6 weeks of treatment
[Time Frame: during the 6 weeks of treatment]
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Secondary Outcome(s)
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12-lead ECG
[Time Frame: during the 6 weeks of treatment]
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Adverse events
[Time Frame: during the 6 weeks of treatment]
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Blood pressure
[Time Frame: during the 6 weeks of treatment]
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body weight
[Time Frame: during the 6 weeks of treatment]
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Secondary ID(s)
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JAPIC: JapicCTI-090711
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NN1250-3569
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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