A Trial Investigating the Safety, Tolerability, and Distribution and Activity in the Body of NNC0148-0000-0287 Injected Under the Skin in Healthy Subjects and in Subjects With Type 1 Diabetes

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 70

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 EXCLUSION CRITERIA TRIAL PART 2 (subjects with type 1 diabetes):
Current treatment with statins, systemic (oral, intravenous or inhaled) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, thyroid hormones, growth hormone and other drugs, which may interfere with glucose metabolism
Increased risk of thrombosis, e.g. subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the past 6 months before start of this trial (screening)
Cardiac problems defined as: decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time, or acute myocardial infarction at any time, or angina pectoris within the last 12 months before start of this trial (screening)
Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trial part 1	148-0287-A-4.2mM-cartridge	-
Trial part 1	placebo	-
Trial part 2, treatment A	148-0287-A-4.2mM-cartridge	-
Trial part 2, treatment A	sodium chloride 0.9% w/v	-
Trial part 2, treatment B	placebo	-
Trial part 2, treatment B	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AE)	From trial product administration until completion of the post-treatment follow-up visit at Day 37

Secondary Outcome Measures

Name	Time	Method
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
Incidence of hypoglycaemic episodes	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	From dosing visit to infinity calculated from a 0-36 days NNC0148-0287 serum concentration-time-curve based on 43 sampling time points
Average morning fasting blood glucose (FBG) concentration	From Day 2 to Day 8
Average morning fasting serum C-peptide concentration	From Day 2 to Day 8
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

A Trial Investigating the Safety, Tolerability, and Distribution and Activity in the Body of NNC0148-0000-0287 Injected Under the Skin in Healthy Subjects and in Subjects With Type 1 Diabetes

Recruitment & Eligibility

Study & Design

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