This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with type 1 diabetes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously.
In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously.
In a dose-escalating design, subjects with type 1 diabetes will receive a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
In a dose-escalating design, subjects with type 1 diabetes will receive 148-0287-A-placebo-cartridge in a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
In a dose-escalating design, subjects with type 1 diabetes will receive insulin glargine once daily, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
In a dose-escalating design, subjects with type 1 diabetes will receive sodium chloride 0.9% w/v, injected subcutaneously daily. Subjects will only be randomised to receive either treatment A or B.
Unnamed facility
Neuss, Germany
Incidence of adverse events (AE)
Time frame: From trial product administration until completion of the post-treatment follow-up visit at Day 37
Incidence of hypoglycaemic episodes
Time frame: From trial product administration until completion of the post-treatment follow-up visit at Day 37
AUC, the area under the serum insulin 287 concentration-time curve
Time frame: From dosing visit to infinity calculated from a 0-36 days NNC0148-0287 serum concentration-time-curve based on 43 sampling time points
Cmax, the maximum serum insulin 287 concentration
Time frame: Observed (within 0-36 days)
tmax, the time for maximum serum insulin 287 concentration
Time frame: Within 0-36 days
Average morning fasting blood glucose (FBG) concentration
Time frame: From Day 2 to Day 8
Average morning fasting serum C-peptide concentration
Time frame: From Day 2 to Day 8
Average morning fasting serum free fatty acid (FFA) concentration
Time frame: From Day 2 to Day 8
Area under the glucose infusion rate (GIR)-time curve
Time frame: At Day 1-2, 4-5, or 7-8
The maximal GIR (glucose infusion rate) observed
Time frame: At Day 1-2, 4-5, or 7-8
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