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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2022-09-09

Brief Summary

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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)

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

AT247

Intervention Type DRUG

Ultra rapid acting prandial insulin aspart

NovoLog

Intervention Type DRUG

Rapid acting prandial insulin aspart

Fiasp

Intervention Type DRUG

Fast acting prandial insulin aspart

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

Group Type ACTIVE_COMPARATOR

AT247

Intervention Type DRUG

Ultra rapid acting prandial insulin aspart

NovoLog

Intervention Type DRUG

Rapid acting prandial insulin aspart

Fiasp

Intervention Type DRUG

Fast acting prandial insulin aspart

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

Group Type ACTIVE_COMPARATOR

AT247

Intervention Type DRUG

Ultra rapid acting prandial insulin aspart

NovoLog

Intervention Type DRUG

Rapid acting prandial insulin aspart

Fiasp

Intervention Type DRUG

Fast acting prandial insulin aspart

Interventions

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AT247

Ultra rapid acting prandial insulin aspart

Intervention Type DRUG

NovoLog

Rapid acting prandial insulin aspart

Intervention Type DRUG

Fiasp

Fast acting prandial insulin aspart

Intervention Type DRUG

Other Intervention Names

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NovoRapid

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No