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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05184868
• Other study ID #: ARE-247-103
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2022
• Est. completion date: September 9, 2022

Study information

• Verified date: September 2022
• Source: Arecor Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Drug:
• AT247
Ultra rapid acting prandial insulin aspart
• NovoLog
Rapid acting prandial insulin aspart
• Fiasp
Fast acting prandial insulin aspart

Locations

Country	Name	City	State
United States	ProSciento, Inc	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Arecor Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under Curve for serum insulin		0-30 minutes
Primary	Area under Curve for Glucose Infusion Rate		0-60 minutes