Diabetes, Diabetes Mellitus, Type 1, Healthy
Conditions
Brief summary
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
Interventions
DRUG148-0287-A-4.2mM-cartridge
In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously.
DRUGplacebo
In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously.
DRUGinsulin glargine
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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* TRIAL PART 1 (HEALTHY SUBJECTS): * Healthy male subject * Age 18-55 years (both inclusive) * Body mass index 18.0-28.0 kg/m\^2 (both inclusive) * TRIAL PART 2 (SUBJECTS WITH TYPE 1 DIABETES): * Healthy male subject (with the exception of conditions associated with diabetes mellitus) * Age 18-64 years (both inclusive) * Body mass index 18.0-28.0 kg/m\^2 (both incl.) * Type 1 diabetes mellitus (as diagnosed clinically) and treated with multiple daily insulin injections more than 12 months * HbA1C (glycosylated haemoglobin) below or equal to 8.5 % * Current daily basal insulin requirement above or equal to 0.2 to below or equal to 0.8 (I)U/kg/day and current total daily insulin treatment below 1.2 (I)U/kg/day * Fasting C-peptide below 0.3 nmol/L
Exclusion criteria
* The receipt of any investigational medicinal product within the last 3 months prior to the start of this trial (screening) * Significant blood loss (due to donation, surgery or trauma) of more than 500 mL within 3 months prior to the start of this trial (screening) or participating in any other trial involving blood sampling within the last 2 months before the start of this trial (screening) * Use of any prescription (see specification below for Trial Part 2) or non-prescription medication, including herbal products and non-routine vitamins, within the last 2 weeks before the start of the trial (screening) that will interfere with the pharmacokinetics of insulin 287, as judged by the investigator in agreement with the sponsor. Routine vitamins and occasional use judged by the investigator in agreement with the sponsor. Routine vitamins and occasional use of paracetamol is permitted up to 48 hours prior to dosing * History of alcoholism or drug abuse (within the last 2 years), or positive result of alcohol or drug screening test * Currently smoke more than 1 cigarette per day (or the equivalent for other tobacco products) or smoking 1 cigarette or less per day and not considering being able to refrain from smoking or refrain from use of other types of nicotine products (e.g. such as chewing tobacco, nicotine gums) during the in-house periods * Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the investigator * Excessive consumption of a diet deviating from a normal diet as judged by the investigator * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation in the trial * Vulnerable subjects (e.g. persons kept in detention) * Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the trial * ADDITIONAL KEY
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AE) | From trial product administration until completion of the post-treatment follow-up visit at Day 37 |
Secondary
| Measure | Time frame |
|---|---|
| AUC, the area under the serum insulin 287 concentration-time curve | 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 | Observed (within 0-36 days) |
| tmax, the time for maximum serum insulin 287 concentration | Within 0-36 days |
| Average morning fasting blood glucose (FBG) concentration | From Day 2 to Day 8 |
| Incidence of hypoglycaemic episodes | From trial product administration until completion of the post-treatment follow-up visit at Day 37 |
| Average morning fasting serum free fatty acid (FFA) concentration | From Day 2 to Day 8 |
| Area under the glucose infusion rate (GIR)-time curve | At Day 1-2, 4-5, or 7-8 |
| The maximal GIR (glucose infusion rate) observed | At Day 1-2, 4-5, or 7-8 |
| Average morning fasting serum C-peptide concentration | From Day 2 to Day 8 |
Countries
Germany
Outcome results
None listed