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
18 participants
INTERVENTIONAL
2019-04-12
2019-08-08
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
QUADRUPLE
Study Groups
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AT247
Single subcutaneous injection 0.3 U/Kg
NovoRapid
Rapid acting prandial insulin aspart
Fiasp
Fast acting prandial insulin aspart
AT247
Ultra rapid acting prandial insulin aspart
NovoRapid
Single subcutaneous injection 0.3 U/Kg
NovoRapid
Rapid acting prandial insulin aspart
Fiasp
Fast acting prandial insulin aspart
AT247
Ultra rapid acting prandial insulin aspart
Fiasp
Single subcutaneous injection 0.3 U/Kg
NovoRapid
Rapid acting prandial insulin aspart
Fiasp
Fast acting prandial insulin aspart
AT247
Ultra rapid acting prandial insulin aspart
Interventions
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NovoRapid
Rapid acting prandial insulin aspart
Fiasp
Fast acting prandial insulin aspart
AT247
Ultra rapid acting prandial insulin aspart
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
3. Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening
4. BMI 18.5-35.0 kg/m2
Exclusion Criteria
2. clinically significant concomitant disease or abnormal lab values
3. supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg
18 Years
64 Years
MALE
No
Sponsors
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Arecor Limited
INDUSTRY
Responsible Party
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Locations
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Clinical Research Centre
Graz, , Austria
Countries
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References
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Svehlikova E, Mursic I, Augustin T, Magnes C, Gerring D, Jezek J, Schwarzenbacher D, Ratzer M, Wolf M, Howell S, Zakrzewski L, Urschitz M, Tschapeller B, Gatschelhofer C, Feichtner F, Lawrence F, Pieber TR. Pharmacokinetics and Pharmacodynamics of Three Different Formulations of Insulin Aspart: A Randomized, Double-Blind, Crossover Study in Men With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):448-455. doi: 10.2337/dc20-1017. Epub 2020 Dec 16.
Other Identifiers
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ARE-247-101
Identifier Type: -
Identifier Source: org_study_id
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