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AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AT247

NovoLog

Fiasp

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects diagnosed with T1DM for at least 12 months.
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.
Fasting C-peptide concentration of ≤0.3 nmol/l (0.9061 ng/ml), assessed at a plasma glucose concentration >90 mg/dL.
HbA1c concentration of ≤8.5% (≤69 mmol/mol).
BMI within the range ≥18.5 - ≤28.0 kg/m2.

Exclusion Criteria:

Known or suspected hypersensitivity to IMP or related products.
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.
Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by the investigator.
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.
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.

Sites / Locations

ProSciento, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

AT247

NovoLog®

Fiasp®

Arm Description

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

Outcomes

Primary Outcome Measures

Area under Curve for serum insulin

Area under Curve for Glucose Infusion Rate

Secondary Outcome Measures

Full Information

NCT ID

NCT05184868

First Posted

December 22, 2021

Last Updated

September 12, 2022

Sponsor

Arecor Limited

1. Study Identification

Unique Protocol Identification Number

NCT05184868

Brief Title

AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

January 3, 2022 (Actual)

Primary Completion Date

September 9, 2022 (Actual)

Study Completion Date

September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arecor Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AT247

Arm Type

Experimental

Arm Description

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

Arm Title

NovoLog®

Arm Type

Active Comparator

Arm Description

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

Arm Title

Fiasp®

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AT247

Intervention Description

Ultra rapid acting prandial insulin aspart

Intervention Type

Drug

Intervention Name(s)

NovoLog

Other Intervention Name(s)

NovoRapid

Intervention Description

Rapid acting prandial insulin aspart

Intervention Type

Drug

Intervention Name(s)

Fiasp

Intervention Description

Fast acting prandial insulin aspart

Primary Outcome Measure Information:

Title

Area under Curve for serum insulin

Time Frame

0-30 minutes

Title

Area under Curve for Glucose Infusion Rate

Time Frame

0-60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects diagnosed with T1DM for at least 12 months. 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. Fasting C-peptide concentration of ≤0.3 nmol/l (0.9061 ng/ml), assessed at a plasma glucose concentration >90 mg/dL. HbA1c concentration of ≤8.5% (≤69 mmol/mol). BMI within the range ≥18.5 - ≤28.0 kg/m2. Exclusion Criteria: Known or suspected hypersensitivity to IMP or related products. 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. Clinically significant concomitant disease including cardiovascular, renal, hepatic, respiratory, gastrointestinal, hematological, dermatological, neurological, psychiatric, systemic or infections disease as judged by the investigator. 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. 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.

Facility Information:

Facility Name

ProSciento, Inc

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

12. IPD Sharing Statement

Learn more about this trial

AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study

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