AT278 and NovoRapid® in Glucose Clamp Study
Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).
1 other identifier
interventional
38
1 country
1
Brief Summary
A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2020
CompletedFirst Submitted
Initial submission to the registry
December 3, 2020
CompletedFirst Posted
Study publicly available on registry
December 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2021
CompletedJuly 21, 2021
December 1, 2020
6 months
December 3, 2020
July 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the glucose infusion-rate curve of insulin aspart
0 - 8 hours
Study Arms (2)
AT278
EXPERIMENTALSingle subcutaneous injection 0.3U/kg
NovoRapid
ACTIVE COMPARATORSingle subcutaneous injection 0.3U/kg
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of type 1 diabetes for at least 12 months
- Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
- HbA1c concentration ≤8.5% at screening
- Weight within the range 75kg - 100kg (both inclusive)
You may not qualify if:
- Known or suspected hypersensitivity to Investigational Medicinal Products
- Clinically significant concomitant disease or abnormal lab values
- Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arecor Limitedlead
Study Sites (1)
Clinical Trials Unit, Medical University of Graz
Graz, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2020
First Posted
December 9, 2020
Study Start
December 2, 2020
Primary Completion
June 3, 2021
Study Completion
June 11, 2021
Last Updated
July 21, 2021
Record last verified: 2020-12