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

NCT05184868 | Completed Phase 1 FDA Drug

• 1 other identifier: ARE-247-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Area under Curve for serum insulin

  0-30 minutes

• Area under Curve for Glucose Infusion Rate

  0-60 minutes

Study Arms (3)

AT247

EXPERIMENTAL

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; Drug: NovoLog; Drug: Fiasp

NovoLog®

ACTIVE COMPARATOR

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; Drug: NovoLog; Drug: Fiasp

Fiasp®

ACTIVE COMPARATOR

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; Drug: NovoLog; Drug: Fiasp

Interventions

AT247 DRUG

Ultra rapid acting prandial insulin aspart

AT247; Fiasp®; NovoLog®

NovoLog DRUG

Rapid acting prandial insulin aspart

Also known as: NovoRapid

AT247; Fiasp®; NovoLog®

Fiasp DRUG

Fast acting prandial insulin aspart

AT247; Fiasp®; NovoLog®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed with T1DM for at least 12 months.
• 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.
• Fasting C-peptide concentration of ≤0.3 nmol/l (0.9061 ng/ml), assessed at a plasma glucose concentration \>90 mg/dL.
• HbA1c concentration of ≤8.5% (≤69 mmol/mol).
• BMI within the range ≥18.5 - ≤28.0 kg/m2.

You may not qualify if:

• Known or suspected hypersensitivity to IMP or related products.
• 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.
• Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by the investigator.
• 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.
• 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.

Sponsors & Collaborators

• Arecor Limited: lead

Study Sites (1)

ProSciento, Inc

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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 22, 2021
• First Posted: January 11, 2022
• Study Start: January 3, 2022
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

US (1)