AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study
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.
2 other identifiers
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes-mellitus-type-2
Started Feb 2023
Typical duration for phase_1 diabetes-mellitus-type-2
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
First Submitted
Initial submission to the registry
February 21, 2023
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedFirst Posted
Study publicly available on registry
March 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2024
CompletedFebruary 16, 2024
February 1, 2024
11 months
February 21, 2023
February 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the glucose infusion rate-time curve of insulin aspart
0 to 60 minutes
Study Arms (2)
AT278
EXPERIMENTALSingle subcutaneous injection of 0.5 U/kg
NovoRapid
ACTIVE COMPARATORSingle subcutaneous injection of 0.5 U/kg
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
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
February 21, 2023
First Posted
March 3, 2023
Study Start
February 27, 2023
Primary Completion
January 18, 2024
Study Completion
February 12, 2024
Last Updated
February 16, 2024
Record last verified: 2024-02