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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

Tracking Information
First Submitted Date  ICMJE December 3, 2020
First Posted Date  ICMJE December 9, 2020
Last Update Posted Date July 21, 2021
Actual Study Start Date  ICMJE December 2, 2020
Actual Primary Completion Date June 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2020)
Area under the glucose infusion-rate curve of insulin aspart [ Time Frame: 0 - 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AT278 and NovoRapid® in Glucose Clamp Study
Official Title  ICMJE 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).
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: AT278
    Concentrated rapid acting insulin aspart
  • Drug: NovoRapid
    Rapid acting insulin aspart
    Other Name: NovoLog
Study Arms  ICMJE
  • Experimental: AT278
    Single subcutaneous injection 0.3U/kg
    Interventions:
    • Drug: AT278
    • Drug: NovoRapid
  • Active Comparator: NovoRapid
    Single subcutaneous injection 0.3U/kg
    Interventions:
    • Drug: AT278
    • Drug: NovoRapid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2020)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 11, 2021
Actual Primary Completion Date June 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04660305
Other Study ID Numbers  ICMJE ARE-278-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arecor Limited
Study Sponsor  ICMJE Arecor Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arecor Limited
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP