AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study

Phase 1 Randomized, Double-blind, Three Period, Crossover Study Comparing PD/PK, Safety and Tolerability Profiles for Arecor Ultra-rapid Insulin Aspart (AT247), NovoLog® and Fiasp® in Participants With T1DM During CSII

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)

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: AT247; Drug: NovoLog; Drug: Fiasp

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • Prosciento, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects diagnosed with T1DM for at least 12 months.
2. Subjects who have been using an approved insulin pump or use multiple daily injections with basal and bolus insulin, with a stable total insulin dose <1.2 U/kg/day and bolus insulin dose <0.7 U/kg/day for at least 3 months.
3. Fasting C-peptide concentration of ≤0.3 nmol/l (0.9061 ng/ml), assessed at a plasma glucose concentration >90 mg/dL.
4. HbA1c concentration of ≤8.5% (≤69 mmol/mol).
5. BMI within the range ≥18.5 - ≤28.0 kg/m2.

Exclusion Criteria:

1. Known or suspected hypersensitivity to IMP or related products.
2. History or presence of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any in-situ carcinomas are allowed.
3. Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by the investigator.
4. Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 95-140 mmHg blood pressure and/or for diastolic blood pressure greater than 90 mmHg.
5. Smoking more than 5 cigarettes per day or equivalent use of any tobacco containing product, and unable to refrain from smoking during the in-house periods of the study. A positive urine cotinine test at screening and check-in.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AT247; 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	Drug: AT247; Ultra rapid acting prandial insulin aspart; Drug: NovoLog; Rapid acting prandial insulin aspart; Other Names: NovoRapid; Drug: Fiasp; Fast acting prandial insulin aspart
Active Comparator: NovoLog®; 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	Drug: AT247; Ultra rapid acting prandial insulin aspart; Drug: NovoLog; Rapid acting prandial insulin aspart; Other Names: NovoRapid; Drug: Fiasp; Fast acting prandial insulin aspart
Active Comparator: Fiasp®; 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	Drug: AT247; Ultra rapid acting prandial insulin aspart; Drug: NovoLog; Rapid acting prandial insulin aspart; Other Names: NovoRapid; Drug: Fiasp; Fast acting prandial insulin aspart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under Curve for serum insulin	0-30 minutes
Area under Curve for Glucose Infusion Rate	0-60 minutes

Collaborators and Investigators

• Sponsor: Arecor Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Aspart
• Other Study ID Numbers: ARE-247-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No