Diabetes Mellitus, Type 1
Conditions
Brief summary
A Phase I, randomised, single-centre, double-blind, single-dose, three period, balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT247, NovoRapid® and Fiasp® in male participants with type I diabetes mellitus.
Interventions
Sponsors
Arecor Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
include: 1. Diagnosis type I Diabetes Mellitus for at least 12 months 2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months 3. Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening 4. BMI 18.5-35.0 kg/m2
Exclusion criteria
include: 1. known or suspected hypersensitivity to Investigational Medicinal Products 2. clinically significant concomitant disease or abnormal lab values 3. supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate-time curve of insulin aspart | 0-60 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum insulin aspart concentration-time curve from 0-60 minutes | 0-60 minutes |
Countries
Austria
Outcome results
None listed