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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-60 minutes
Awards & highlights
Study Summary
Phase 1 randomized, double-blind, three period, crossover study comparing the pharmacodynamic, pharmacokinetic, safety and tolerability profiles for Arecor ultra-rapid insulin aspart (AT247), NovoLog® and Fiasp® in participants with type 1 diabetes mellitus (T1DM) during continuous subcutaneous infusion (CSII)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under Curve for Glucose Infusion Rate
Area under Curve for serum insulin
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: AT247Experimental Treatment3 Interventions
0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period
Group II: Fiasp®Active Control3 Interventions
0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period
Group III: NovoLog®Active Control3 Interventions
0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fiasp
2019
Completed Phase 4
~150
NovoLog
2022
Completed Phase 3
~250
AT247
2019
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Arecor LimitedLead Sponsor
3 Previous Clinical Trials
97 Total Patients Enrolled
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