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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 18, 2014
First Posted Date  ICMJE August 19, 2014
Last Update Posted Date December 8, 2017
Actual Study Start Date  ICMJE August 20, 2014
Actual Primary Completion Date March 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
Incidence of adverse events [ Time Frame: Day 1 - day 22 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
  • Incidence of hypoglycaemic episodes [ Time Frame: Day 1 - day 22 ]
  • Area under the serum insulin 338 concentration-time curve from zero to infinity [ Time Frame: Day 1- day 22 ]
  • Maximum serum insulin 338 concentration observed [ Time Frame: Day 1- day 22 ]
  • Time for maximum serum insulin 338 concentration [ Time Frame: Day 1- day 22 ]
  • t1/2, the terminal half-life of insulin 338 [ Time Frame: Day 1- day 22 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
Official Title  ICMJE A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: Insulin 338
    Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).
  • Drug: placebo
    Healthy subjects will receive a single dose of placebo. Injected subcutaneously (under the skin).
  • Drug: Insulin 338
    Subjects with type 1 DM will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).
  • 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).
Study Arms  ICMJE
  • Experimental: Part 1 insulin 338
    Intervention: Drug: Insulin 338
  • Placebo Comparator: Part 1 placebo
    Intervention: Drug: placebo
  • Experimental: Part 2 insulin 338
    Intervention: Drug: Insulin 338
  • Active Comparator: Part 2 insulin glargine
    Intervention: Drug: insulin glargine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2015)
62
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2014)
66
Actual Study Completion Date  ICMJE March 31, 2015
Actual Primary Completion Date March 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02220296
Other Study ID Numbers  ICMJE NN1438-4137
2014-000071-70 ( EudraCT Number )
U1111-1151-9327 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP