AT278 and NovoRapid® in Glucose Clamp Study

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: AT278; Drug: NovoRapid

• Registration Number: NCT04660305
• Lead Sponsor: Arecor Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-02
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-09
• Primary Completion: 2021-06-03
• Study Completion: 2021-06-11
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NovoRapid	NovoRapid	Single subcutaneous injection 0.3U/kg
AT278	AT278	Single subcutaneous injection 0.3U/kg
AT278	NovoRapid	Single subcutaneous injection 0.3U/kg
NovoRapid	AT278	Single subcutaneous injection 0.3U/kg

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion-rate curve of insulin aspart	0 - 8 hours

Trial Locations

Locations (1)

Clinical Trials Unit, Medical University of Graz; 🇦🇹 Graz, Austria