Back to resultsAT278 and NovoRapid® in Glucose Clamp Study
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
AT278
NovoRapid
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Clinical Trials Unit, Medical University of Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AT278
NovoRapid
Arm Description
Single subcutaneous injection 0.3U/kg
Single subcutaneous injection 0.3U/kg
Outcomes
Primary Outcome Measures
Area under the glucose infusion-rate curve of insulin aspart
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04660305
Brief Title
AT278 and NovoRapid® in Glucose Clamp Study
Official Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
June 3, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arecor Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AT278
Arm Type
Experimental
Arm Description
Single subcutaneous injection 0.3U/kg
Arm Title
NovoRapid
Arm Type
Active Comparator
Arm Description
Single subcutaneous injection 0.3U/kg
Intervention Type
Drug
Intervention Name(s)
AT278
Intervention Description
Concentrated rapid acting insulin aspart
Intervention Type
Drug
Intervention Name(s)
NovoRapid
Other Intervention Name(s)
NovoLog
Intervention Description
Rapid acting insulin aspart
Primary Outcome Measure Information:
Title
Area under the glucose infusion-rate curve of insulin aspart
Time Frame
0 - 8 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Facility Information:
Facility Name
Clinical Trials Unit, Medical University of Graz
City
Graz
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
AT278 and NovoRapid® in Glucose Clamp Study
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