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

NCT ID: NCT02220296

Last Updated: 2017-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-20
• Study Completion Date: 2015-03-31

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.

Conditions

Healthy; Diabetes; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1 insulin 338

Group Type: EXPERIMENTAL

Insulin 338

Intervention Type: DRUG

Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).

Part 1 placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Healthy subjects will receive a single dose of placebo. Injected subcutaneously (under the skin).

Part 2 insulin 338

Group Type: EXPERIMENTAL

Insulin 338

Intervention Type: DRUG

Subjects with type 1 DM will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).

Part 2 insulin glargine

Group Type: ACTIVE_COMPARATOR

insulin glargine

Intervention Type: DRUG

Subjects with type 1 DM will receive 0.4 U/kg insulin glargine once daily for 4 days. Injected subcutaneously (under the skin).

Interventions

Insulin 338

Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).

Intervention Type: DRUG

placebo

Healthy subjects will receive a single dose of placebo. Injected subcutaneously (under the skin).

Intervention Type: DRUG

Insulin 338

Subjects with type 1 DM will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Neuss, , Germany

Countries

Germany

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2014-000071-70

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1151-9327

Identifier Type: OTHER

Identifier Source: secondary_id

NN1438-4137

Identifier Type: -

Identifier Source: org_study_id