Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
NCT ID: NCT02568280
Last Updated: 2018-12-11
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
42 participants
INTERVENTIONAL
2015-10-06
2016-04-25
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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Faster aspart
Faster-acting insulin aspart
Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
Insulin aspart
insulin aspart
Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
Interventions
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Faster-acting insulin aspart
Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
insulin aspart
Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
Eligibility Criteria
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Inclusion Criteria
* Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
* Body mass index 18.5-28.0 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
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
Graz, , Austria
Countries
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References
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Basu A, Pieber TR, Hansen AK, Sach-Friedl S, Erichsen L, Basu R, Haahr H. Greater early postprandial suppression of endogenous glucose production and higher initial glucose disappearance is achieved with fast-acting insulin aspart compared with insulin aspart. Diabetes Obes Metab. 2018 Jul;20(7):1615-1622. doi: 10.1111/dom.13270. Epub 2018 Mar 30.
Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2014-004144-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1162-2053
Identifier Type: OTHER
Identifier Source: secondary_id
NN1218-3922
Identifier Type: -
Identifier Source: org_study_id
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