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

• ClinicalTrials.gov Identifier: NCT02220296
• Recruitment Status: Completed
• First Posted: August 19, 2014
• Last Update Posted: December 8, 2017
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

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 glargine	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: August 20, 2014
• Actual Primary Completion Date: March 31, 2015
• Actual Study Completion Date: March 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 :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Germany

Novo Nordisk Investigational Site

Neuss, Germany, 41460

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk 

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02220296
• Other Study ID Numbers: NN1438-4137; 2014-000071-70 ( EudraCT Number ); U1111-1151-9327 ( Other Identifier: WHO )
• First Posted: August 19, 2014
• Last Update Posted: December 8, 2017
• Last Verified: December 2017

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin; Insulin, Globin Zinc; Insulin Glargine; Hypoglycemic Agents; Physiological Effects of Drugs