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Trial record 41 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

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).




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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220296


Locations
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Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

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

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
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