Status:
COMPLETED
AT247, NovoLog® and Fiasp® Administered Via Continuous Subcutaneous Infusion in Glucose Clamp Study
Lead Sponsor:
Arecor Limited
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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®...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05184868
Start Date
January 3 2022
End Date
September 9 2022
Last Update
September 13 2022
Active Locations (1)
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1
ProSciento, Inc
Chula Vista, California, United States, 91911