AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

Arecor

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Biological: Fiasp; Biological: NovoRapid; Biological: AT247

Study type: Interventional

Funder types: Industry

Identifiers

NCT03959514

ARE-247-101

Details and patient eligibility

About

A Phase I, randomised, single-centre, double-blind, single-dose, three period, balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT247, NovoRapid® and Fiasp® in male participants with type I diabetes mellitus.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria include:

1. Diagnosis type I Diabetes Mellitus for at least 12 months
2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
3. Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening
4. BMI 18.5-35.0 kg/m2

Exclusion Criteria include:

1. known or suspected hypersensitivity to Investigational Medicinal Products
2. clinically significant concomitant disease or abnormal lab values
3. supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 3 patient groups

AT247

Experimental group

Description:

Single subcutaneous injection 0.3 U/Kg

Treatment:

Biological: Fiasp

Biological: AT247

Biological: NovoRapid

NovoRapid

Active Comparator group

Description:

Single subcutaneous injection 0.3 U/Kg

Treatment:

Biological: Fiasp

Biological: AT247

Biological: NovoRapid

Fiasp

Active Comparator group

Description:

Single subcutaneous injection 0.3 U/Kg

Treatment:

Biological: Fiasp

Biological: AT247

Biological: NovoRapid