AT278 and NovoRapid® in Glucose Clamp Study

Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).

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.

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