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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: |
NCT00964418 |
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Date of registration:
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24/08/2009 |
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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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A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes
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Scientific title:
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A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 in Young and Geriatric Subjects With Type 1 Diabetes |
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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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27 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00964418 |
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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: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Austria
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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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 A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years
(geriatric group)
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
Age minimum:
18 Years
Age maximum:
65 Years
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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Diabetes
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Intervention(s)
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Drug: insulin degludec
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Drug: insulin glargine
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Primary Outcome(s)
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Area under the glucose infusion rate curve during one dosing interval at steady state (for NN1250)
[Time Frame: 0-24 hours (derived on treatment day 6)]
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Secondary Outcome(s)
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Area under the NN1250 concentration-time curve during one dosing interval at steady state
[Time Frame: 0-24 hours (derived on treatment day 6)]
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Secondary ID(s)
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2008-008601-21
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NN1250-1994
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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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