AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

September 27, 2019 updated by: Arecor Limited

Phase I Single Dose, Randomised, Double-blind, Three-way Cross Over, Glucose Clamp Study Investigating the PK/PD and Safety of Arecor Ultra-rapid Insulin Aspart (AT247) in Comparison to NovoRapid® and Fiasp® in Participants With Type I Diabetes Mellitus (T1DM).

A Phase I, randomised, single-centre, double-blind, single-dose, three period, balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT247, NovoRapid® and Fiasp® in male participants with type I diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria include:

  1. Diagnosis type I Diabetes Mellitus for at least 12 months
  2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
  3. Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening
  4. BMI 18.5-35.0 kg/m2

Exclusion Criteria include:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AT247
Single subcutaneous injection 0.3 U/Kg
Biological: NovoRapid
Rapid acting prandial insulin aspart
Other Names:
  • NovoLog
Biological: Fiasp
Fast acting prandial insulin aspart
Biological: AT247
Ultra rapid acting prandial insulin aspart
Active Comparator: NovoRapid
Single subcutaneous injection 0.3 U/Kg
Biological: NovoRapid
Rapid acting prandial insulin aspart
Other Names:
  • NovoLog
Biological: Fiasp
Fast acting prandial insulin aspart
Biological: AT247
Ultra rapid acting prandial insulin aspart
Active Comparator: Fiasp
Single subcutaneous injection 0.3 U/Kg
Biological: NovoRapid
Rapid acting prandial insulin aspart
Other Names:
  • NovoLog
Biological: Fiasp
Fast acting prandial insulin aspart
Biological: AT247
Ultra rapid acting prandial insulin aspart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the glucose infusion rate-time curve of insulin aspart
Time Frame: 0-60 minutes
0-60 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the serum insulin aspart concentration-time curve from 0-60 minutes
Time Frame: 0-60 minutes
0-60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arecor Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2019

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

August 8, 2019

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARE-247-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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