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AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion 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: NCT05184868
Recruitment Status : Completed
First Posted : January 11, 2022
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Arecor Limited

Brief Summary:
Phase 1 randomized, double-blind, three period, crossover study comparing the pharmacodynamic, pharmacokinetic, safety and tolerability profiles for Arecor ultra-rapid insulin aspart (AT247), NovoLog® and Fiasp® in participants with type 1 diabetes mellitus (T1DM) during continuous subcutaneous infusion (CSII)

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: AT247 Drug: NovoLog Drug: Fiasp Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Randomized, Double-blind, Three Period, Crossover Study Comparing PD/PK, Safety and Tolerability Profiles for Arecor Ultra-rapid Insulin Aspart (AT247), NovoLog® and Fiasp® in Participants With T1DM During CSII
Actual Study Start Date : January 3, 2022
Actual Primary Completion Date : September 9, 2022
Actual Study Completion Date : September 9, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: AT247
0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period
Drug: AT247
Ultra rapid acting prandial insulin aspart

Drug: NovoLog
Rapid acting prandial insulin aspart
Other Name: NovoRapid

Drug: Fiasp
Fast acting prandial insulin aspart

Active Comparator: NovoLog®
0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period
Drug: AT247
Ultra rapid acting prandial insulin aspart

Drug: NovoLog
Rapid acting prandial insulin aspart
Other Name: NovoRapid

Drug: Fiasp
Fast acting prandial insulin aspart

Active Comparator: Fiasp®
0.02 U/Kg/H Basal via continuous subcutaneous infusion with 2 bolus 0.15 U/Kg doses in a glucose clamp for one 3-day period
Drug: AT247
Ultra rapid acting prandial insulin aspart

Drug: NovoLog
Rapid acting prandial insulin aspart
Other Name: NovoRapid

Drug: Fiasp
Fast acting prandial insulin aspart




Primary Outcome Measures :
  1. Area under Curve for serum insulin [ Time Frame: 0-30 minutes ]
  2. Area under Curve for Glucose Infusion Rate [ Time Frame: 0-60 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects diagnosed with T1DM for at least 12 months.
  2. Subjects who have been using an approved insulin pump or use multiple daily injections with basal and bolus insulin, with a stable total insulin dose <1.2 U/kg/day and bolus insulin dose <0.7 U/kg/day for at least 3 months.
  3. Fasting C-peptide concentration of ≤0.3 nmol/l (0.9061 ng/ml), assessed at a plasma glucose concentration >90 mg/dL.
  4. HbA1c concentration of ≤8.5% (≤69 mmol/mol).
  5. BMI within the range ≥18.5 - ≤28.0 kg/m2.

Exclusion Criteria:

  1. Known or suspected hypersensitivity to IMP or related products.
  2. History or presence of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any in-situ carcinomas are allowed.
  3. Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by the investigator.
  4. Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 95-140 mmHg blood pressure and/or for diastolic blood pressure greater than 90 mmHg.
  5. Smoking more than 5 cigarettes per day or equivalent use of any tobacco containing product, and unable to refrain from smoking during the in-house periods of the study. A positive urine cotinine test at screening and check-in.

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): NCT05184868


Locations
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United States, California
ProSciento, Inc
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Arecor Limited
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Responsible Party: Arecor Limited
ClinicalTrials.gov Identifier: NCT05184868    
Other Study ID Numbers: ARE-247-103
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022

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