Back to resultsAT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
AT278
NovoRapid
Humulin R 500 UNT/ML Injectable Solution
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria: Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening. BMI within the range of 25 - 45 kg/m2 (both inclusive) Exclusion Criteria: Known or suspected hypersensitivity to IMPs or related products Clinically significant concomitant disease or abnormal lab values Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists
Sites / Locations
- Clinical Trials Unit, Medical University of GrazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AT278
NovoRapid
Arm Description
Single subcutaneous injection of 0.5 U/kg
Single subcutaneous injection of 0.5 U/kg
Outcomes
Primary Outcome Measures
Area under the glucose infusion rate-time curve of insulin aspart
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05754424
Brief Title
AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study
Official Title
A Phase 1, Single Centre, Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics, and Safety of Ultra-rapid-acting Concentrated Insulin Aspart AT278 in Comparison to Standard Insulin Aspart NovoRapid® With an Additional Open Comparison to Humulin® R U-500 in Participants With Type 2 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
November 25, 2023 (Anticipated)
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
This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AT278
Arm Type
Experimental
Arm Description
Single subcutaneous injection of 0.5 U/kg
Arm Title
NovoRapid
Arm Type
Active Comparator
Arm Description
Single subcutaneous injection of 0.5 U/kg
Intervention Type
Drug
Intervention Name(s)
AT278
Intervention Description
Concentrated rapid acting insulin aspart
Intervention Type
Drug
Intervention Name(s)
NovoRapid
Intervention Description
Rapid-acting insulin aspart
Intervention Type
Drug
Intervention Name(s)
Humulin R 500 UNT/ML Injectable Solution
Intervention Description
Regular human insulin
Primary Outcome Measure Information:
Title
Area under the glucose infusion rate-time curve of insulin aspart
Time Frame
0 to 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening
Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening.
BMI within the range of 25 - 45 kg/m2 (both inclusive)
Exclusion Criteria:
Known or suspected hypersensitivity to IMPs or related products
Clinically significant concomitant disease or abnormal lab values
Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Svehlikova, MD
Phone
+43 316 385 80416
Email
eva.svehlilkova@medunigraz.at
Facility Information:
Facility Name
Clinical Trials Unit, Medical University of Graz
City
Graz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Svehlikova, MD
12. IPD Sharing Statement
Learn more about this trial
AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study
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