A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes
NCT ID: NCT01992588
Last Updated: 2016-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2013-11-30
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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FIAsp followed by NovoRapid®
Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days
Faster-acting insulin aspart
Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion.
The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.
NovoRapid® followed by FIAsp
Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days
insulin aspart
Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion.
The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.
Interventions
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Faster-acting insulin aspart
Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion.
The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.
insulin aspart
Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion.
The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.
Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index (BMI) 18.5-28.0 kg/m\^2 (both inclusive)
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
Exclusion Criteria
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
18 Years
64 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Neuss, , Germany
Countries
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References
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Heise T, Zijlstra E, Nosek L, Rikte T, Haahr H. Pharmacological properties of faster-acting insulin aspart vs insulin aspart in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion: A randomized, double-blind, crossover trial. Diabetes Obes Metab. 2017 Feb;19(2):208-215. doi: 10.1111/dom.12803. Epub 2016 Nov 14.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2011-000913-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1119-5358
Identifier Type: OTHER
Identifier Source: secondary_id
NN1218-3890
Identifier Type: -
Identifier Source: org_study_id