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AT278 and NovoRapid® 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: NCT04660305
Recruitment Status : Completed
First Posted : December 9, 2020
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Arecor Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: AT278 Drug: NovoRapid Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Single Dose, Randomised, Double-blind, Two-way Crossover, Glucose Clamp Study Investigating the Pharmacodynamics, Pharmacokinetics and Safety of Arecor Rapid-acting Concentrated Insulin Aspart (AT278) in Comparison to Insulin Aspart NovoRapid® in Participants With Type 1 Diabetes Mellitus (T1DM).
Actual Study Start Date : December 2, 2020
Actual Primary Completion Date : June 3, 2021
Actual Study Completion Date : June 11, 2021

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: AT278
Single subcutaneous injection 0.3U/kg
 Drug: AT278
Concentrated rapid acting insulin aspart

Drug: NovoRapid
Rapid acting insulin aspart
Other Name: NovoLog
Active Comparator: NovoRapid
Single subcutaneous injection 0.3U/kg
 Drug: AT278
Concentrated rapid acting insulin aspart

Drug: NovoRapid
Rapid acting insulin aspart
Other Name: NovoLog


Outcome Measures
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Primary Outcome Measures :
  1. Area under the glucose infusion-rate curve of insulin aspart [ Time Frame: 0 - 8 hours ]

Eligibility Criteria
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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:

  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
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): NCT04660305


Locations
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Austria
Clinical Trials Unit, Medical University of Graz
Graz, Austria
Sponsors and Collaborators
Arecor Limited
More Information
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Responsible Party: Arecor Limited
ClinicalTrials.gov Identifier: NCT04660305    
Other Study ID Numbers: ARE-278-102
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: December 2020

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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