A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02220296
• Date of registration: 18/08/2014
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
• Scientific title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
• Date of first enrolment: August 20, 2014
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02220296
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Trial Part 1 (Healthy subjects):

- Male subject

- Age 18-55 (both inclusive) at the time of signing inform consent

- Body mass index 19.0-29.9 kg/m^2 (both inclusive)

- Trial Part 2 (Subjects with type 1 diabetes mellitus):

- Male subject or female subject of non-child bearing potential. Non-child bearing
potential: being surgically sterilized (i.e. tubal ligation, bilateral oopherectomies
or hysterectomised) for more than 3 months or being postmenopausal (as defined by
amenorrhoea for at least 2 years prior to screening and documented by
follicle-stimulating hormone (FSH) 40 U/L)

- Age 18-64 years (both inclusive) at the time of signing inform consent

- Body mass index 19.0-29.9 kg/m^2 (both inclusive)

- Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer

- Treated with multiple daily insulin injections or insulin pump treatment for 12 months
or longer

- Glycated hemoglobin (HbA1c) 9.0% or less

- Fasting C-peptide less than 0.3 nmol/L

Exclusion Criteria:

- Trial Part 1 (healthy subjects):

- History of, or presence of, cancer, diabetes mellitus or any clinically significant
cardiovascular, respiratory, metabolic (including dyslipidemia), renal, hepatic,
gastrointestinal, endocrinological, haematological, dermatological, venereal,
neurological, psychiatric diseases or other major disorders, as judged by the
investigator

- 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

- 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

- Trial Part 2 (subjects with type 1 diabetes mellitus):

- History of, or presence of, cancer or any clinically significant respiratory,
metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception of
conditions associated with diabetes mellitus), haematological, dermatological,
venereal, neurological, psychiatric, other major disorders or personal and/or family
history of thromboembolism, as judged by the investigator

- 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: 1) decompensated heart failure (New York Heart
Association (NYHA) class III and IV) at any time, or 2) acute myocardial infarction at
any time, or 3) angina pectoris within the last 12 months before start of this trial
(screening)

- 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.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Healthy

Diabetes

Intervention(s)

Drug: insulin glargine

Drug: placebo

Drug: Insulin 338

Primary Outcome(s)

Incidence of adverse events [Time Frame: Day 1 - day 22]

Secondary Outcome(s)

Maximum serum insulin 338 concentration observed [Time Frame: Day 1- day 22]

Incidence of hypoglycaemic episodes [Time Frame: Day 1 - day 22]

Time for maximum serum insulin 338 concentration [Time Frame: Day 1- day 22]

t1/2, the terminal half-life of insulin 338 [Time Frame: Day 1- day 22]

Area under the serum insulin 338 concentration-time curve from zero to infinity [Time Frame: Day 1- day 22]

Secondary ID(s)

U1111-1151-9327

2014-000071-70

NN1438-4137

Source(s) of Monetary Support

Please refer to primary and secondary sponsors