AT278 and NovoRapid® in Glucose Clamp Study

NCT ID: NCT04660305

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-02

Study Completion Date

2021-06-11

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AT278

Single subcutaneous injection 0.3U/kg

Group Type EXPERIMENTAL

AT278

Intervention Type DRUG

Concentrated rapid acting insulin aspart

NovoRapid

Intervention Type DRUG

Rapid acting insulin aspart

NovoRapid

Single subcutaneous injection 0.3U/kg

Group Type ACTIVE_COMPARATOR

AT278

Intervention Type DRUG

Concentrated rapid acting insulin aspart

NovoRapid

Intervention Type DRUG

Rapid acting insulin aspart

Interventions

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AT278

Concentrated rapid acting insulin aspart

Intervention Type DRUG

NovoRapid

Rapid acting insulin aspart

Intervention Type DRUG

Other Intervention Names

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NovoLog

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Arecor Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Trials Unit, Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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ARE-278-102

Identifier Type: -

Identifier Source: org_study_id

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