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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02220296

Collaborator

(none)

Enrollment

Location

Arms

7.3

Actual Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Diabetes Diabetes Mellitus, Type 1	Drug: Insulin 338 Drug: placebo Drug: Insulin 338 Drug: insulin glargine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 20, 2014

Actual Primary Completion Date :

Mar 31, 2015

Actual Study Completion Date :

Mar 31, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 insulin 338	Drug: Insulin 338 Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).
Placebo Comparator: Part 1 placebo	Drug: placebo Healthy subjects will receive a single dose of placebo. Injected subcutaneously (under the skin).
Experimental: Part 2 insulin 338	Drug: Insulin 338 Subjects with type 1 DM will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).
Active Comparator: Part 2 insulin glargine	Drug: 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).

Outcome Measures

Primary Outcome Measures

Incidence of adverse events [Day 1 - day 22]

Secondary Outcome Measures

Incidence of hypoglycaemic episodes [Day 1 - day 22]
Area under the serum insulin 338 concentration-time curve from zero to infinity [Day 1- day 22]
Maximum serum insulin 338 concentration observed [Day 1- day 22]
Time for maximum serum insulin 338 concentration [Day 1- day 22]
t1/2, the terminal half-life of insulin 338 [Day 1- day 22]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.