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AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03959514
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Arecor Limited

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Biological: NovoRapid Biological: Fiasp Biological: AT247 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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).
Actual Study Start Date : April 12, 2019
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : August 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: AT247
Single subcutaneous injection 0.3 U/Kg
 Biological: NovoRapid
Rapid acting prandial insulin aspart
Other Name: 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 Name: 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 Name: NovoLog

Biological: Fiasp
Fast acting prandial insulin aspart

Biological: AT247
Ultra rapid acting prandial insulin aspart


Outcome Measures
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Primary Outcome Measures :
  1. Area under the glucose infusion rate-time curve of insulin aspart [ Time Frame: 0-60 minutes ]

Secondary Outcome Measures :
  1. Area under the serum insulin aspart concentration-time curve from 0-60 minutes [ Time Frame: 0-60 minutes ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959514


Locations
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Austria
Clinical Research Centre
Graz, Austria, 8010
Sponsors and Collaborators
Arecor Limited
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arecor Limited
ClinicalTrials.gov Identifier: NCT03959514    
Other Study ID Numbers: ARE-247-101
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs