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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220296
• Other study ID #: NN1438-4137
• Secondary ID: 2014-000071-70U1
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2014
• Last updated: December 6, 2017
• Start date: August 20, 2014
• Est. completion date: March 31, 2015

Study information

• Verified date: December 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The purpose is to evaluate safety and tolerability of a range of single doses of subcutaneous insulin 338.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 31, 2015
• Est. primary completion date: March 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Healthy

Intervention

Drug:
• Insulin 338
Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).
• placebo
Healthy subjects will receive a single dose of placebo. Injected subcutaneously (under the skin).
• Insulin 338
Subjects with type 1 DM will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).
• insulin glargine
Subjects with type 1 DM will receive 0.4 U/kg insulin glargine once daily for 4 days. Injected subcutaneously (under the skin).

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Day 1 - day 22
Secondary	Incidence of hypoglycaemic episodes		Day 1 - day 22
Secondary	Area under the serum insulin 338 concentration-time curve from zero to infinity		Day 1- day 22
Secondary	Maximum serum insulin 338 concentration observed		Day 1- day 22
Secondary	Time for maximum serum insulin 338 concentration		Day 1- day 22
Secondary	t1/2, the terminal half-life of insulin 338		Day 1- day 22

External Links

•   Clinical Trials at Novo Nordisk