A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT02933853
Last Updated: 2019-05-24
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
61 participants
INTERVENTIONAL
2016-10-14
2017-12-21
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
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
Insulin Aspart
Insulin Aspart
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
Interventions
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Faster-acting insulin aspart
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
Insulin Aspart
A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
Eligibility Criteria
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Inclusion Criteria
* 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
* Surgery or trauma with significant blood loss (more than 500 mL) within the last 90 days prior to screening
18 Years
70 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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Pieber TR, Svehlikova E, Brunner M, Halberg IB, Due Thomsen KM, Haahr H. Fast-acting insulin aspart in people with type 2 diabetes: Earlier onset and greater initial exposure and glucose-lowering effect compared with insulin aspart. Diabetes Obes Metab. 2019 Sep;21(9):2068-2075. doi: 10.1111/dom.13767. Epub 2019 Jun 10.
Other Identifiers
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2016-000200-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1178-3964
Identifier Type: OTHER
Identifier Source: secondary_id
NN1218-4265
Identifier Type: -
Identifier Source: org_study_id
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