AT278 and NovoRapid® in Glucose Clamp Study

Arecor

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: NovoRapid; Drug: AT278

Study type: Interventional

Funder types: Industry

Identifiers

NCT04660305

ARE-278-102

Details and patient eligibility

About

A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.

Enrollment: 38 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of type 1 diabetes for at least 12 months
2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
3. HbA1c concentration ≤8.5% at screening
4. Weight within the range 75kg - 100kg (both inclusive)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups

AT278

Experimental group

Description:

Single subcutaneous injection 0.3U/kg

Treatment:

Drug: AT278

Drug: NovoRapid

NovoRapid

Active Comparator group

Description:

Single subcutaneous injection 0.3U/kg

Treatment:

Drug: AT278

Drug: NovoRapid