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

NCT02220296 | Completed Phase 1

• 3 other identifiers: NN1438-41372014-000071-70U1111-1151-9327
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Day 1 - day 22

Secondary Outcomes (5)

• 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

Study Arms (4)

Part 1 insulin 338

EXPERIMENTAL

Drug: Insulin 338

Part 1 placebo

PLACEBO COMPARATOR

Drug: placebo

Part 2 insulin 338

EXPERIMENTAL

Drug: Insulin 338

Part 2 insulin glargine

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

Insulin 338 DRUG

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

Part 1 insulin 338

placebo DRUG

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

Part 1 placebo

insulin glargine DRUG

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

Part 2 insulin glargine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 19, 2014
• Study Start: August 20, 2014
• Primary Completion: March 31, 2015
• Study Completion: March 31, 2015
• Last Updated: December 8, 2017

Record last verified: 2017-12

Locations

DE (1)