AT278 and NovoRapid® in Glucose Clamp Study

• Status: Completed
• Trial end date: 2021-06-11
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arecor Limited
• Treatments: Insulin Aspart

Criteria

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