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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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12 December 2020 |
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Main ID: |
NCT02933853 |
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Date of registration:
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13/10/2016 |
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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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A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
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Scientific title:
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This Trial is Conducted in Europe. The Aim of This Trial is to Investigate Pharmacokinetic (the Exposure of the Trial Drug in the Body) and Pharmacodynamic (the Effect of the Investigated Drug on the Body) Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus |
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Date of first enrolment:
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October 14, 2016 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02933853 |
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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 18-75 years (both inclusive) at the time of signing informed
consent. The total number of subjects aged 65-75 years (both inclusive) must NOT
exceed 25.
- Subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months
(365 days) prior to the day of screening
- HbA1C below or equal to 9.5 % based on central laboratory analysis
Exclusion Criteria:
- Smoker (defined as a subject who is smoking more than one cigarette or the equivalent
per day) who is not able or willing to refrain from smoking and use of nicotine
substitute products during the in-patient period
- Surgery or trauma with significant blood loss (more than 500 mL) within the last 90
days prior to screening
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Diabetes
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Intervention(s)
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Drug: Insulin Aspart
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Drug: Faster-acting insulin aspart
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Primary Outcome(s)
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Area under the serum insulin aspart concentration-time curve
[Time Frame: From 0 to 30 minutes]
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Secondary Outcome(s)
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Maximum glucose infusion rate
[Time Frame: Within 0 to 12 hours after dosing]
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Maximum observed serum insulin aspart concentration
[Time Frame: Within 0 to 12 hours after dosing]
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Area under the glucose infusion rate curve
[Time Frame: From 0 to t, where t is the last time where glucose infusion rate (GIR) exceeds zero (within 0 to 12 hours after dosing)]
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Secondary ID(s)
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NN1218-4265
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U1111-1178-3964
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2016-000200-28
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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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