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A Trial Investigating the Safety, Tolerability, and Distribution and Activity in the Body of NNC0148-0000-0287 Injected Under the Skin in Healthy Subjects and in Subjects With Type 1 Diabetes

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: NCT01730014
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE November 6, 2012
First Posted Date  ICMJE November 21, 2012
Last Update Posted Date July 31, 2013
Study Start Date  ICMJE October 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
Incidence of adverse events (AE) [ Time Frame: From trial product administration until completion of the post-treatment follow-up visit at Day 37 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
  • Incidence of hypoglycaemic episodes [ Time Frame: From trial product administration until completion of the post-treatment follow-up visit at Day 37 ]
  • AUC, the area under the serum insulin 287 concentration-time curve [ Time Frame: From dosing visit to infinity calculated from a 0-36 days NNC0148-0287 serum concentration-time-curve based on 43 sampling time points ]
  • Cmax, the maximum serum insulin 287 concentration [ Time Frame: Observed (within 0-36 days) ]
  • tmax, the time for maximum serum insulin 287 concentration [ Time Frame: Within 0-36 days ]
  • Average morning fasting blood glucose (FBG) concentration [ Time Frame: From Day 2 to Day 8 ]
  • Average morning fasting serum C-peptide concentration [ Time Frame: From Day 2 to Day 8 ]
  • Average morning fasting serum free fatty acid (FFA) concentration [ Time Frame: From Day 2 to Day 8 ]
  • Area under the glucose infusion rate (GIR)-time curve [ Time Frame: At Day 1-2, 4-5, or 7-8 ]
  • The maximal GIR (glucose infusion rate) observed [ Time Frame: At Day 1-2, 4-5, or 7-8 ]
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, and Distribution and Activity in the Body of NNC0148-0000-0287 Injected Under the Skin in Healthy Subjects and in Subjects With Type 1 Diabetes
Official Title  ICMJE A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0148-0000-0287 in Healthy Subjects and in Subjects With Type 1 Diabetes
Brief Summary This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous NNC0148-0000-0287 (insulin 287) in healthy subjects and in subjects with type 1 diabetes
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Healthy
Intervention  ICMJE
  • Drug: 148-0287-A-4.2mM-cartridge
    In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously.
  • Drug: placebo
    In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously.
  • Drug: 148-0287-A-4.2mM-cartridge
    In a dose-escalating design, subjects with type 1 diabetes will receive a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
  • Drug: placebo
    In a dose-escalating design, subjects with type 1 diabetes will receive 148-0287-A-placebo-cartridge in a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
  • Drug: insulin glargine
    In a dose-escalating design, subjects with type 1 diabetes will receive insulin glargine once daily, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
  • Drug: sodium chloride 0.9% w/v
    In a dose-escalating design, subjects with type 1 diabetes will receive sodium chloride 0.9% w/v, injected subcutaneously daily. Subjects will only be randomised to receive either treatment A or B.
Study Arms  ICMJE
  • Experimental: Trial part 1
    Interventions:
    • Drug: 148-0287-A-4.2mM-cartridge
    • Drug: placebo
  • Experimental: Trial part 2, treatment A
    Interventions:
    • Drug: 148-0287-A-4.2mM-cartridge
    • Drug: sodium chloride 0.9% w/v
  • Experimental: Trial part 2, treatment B
    Interventions:
    • Drug: placebo
    • 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: July 30, 2013)
70
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2012)
84
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • TRIAL PART 1 (HEALTHY SUBJECTS):
  • Healthy male subject
  • Age 18-55 years (both inclusive)
  • Body mass index 18.0-28.0 kg/m^2 (both inclusive)
  • TRIAL PART 2 (SUBJECTS WITH TYPE 1 DIABETES):
  • Healthy male subject (with the exception of conditions associated with diabetes mellitus)
  • Age 18-64 years (both inclusive)
  • Body mass index 18.0-28.0 kg/m^2 (both incl.)
  • Type 1 diabetes mellitus (as diagnosed clinically) and treated with multiple daily insulin injections more than 12 months
  • HbA1C (glycosylated haemoglobin) below or equal to 8.5 %
  • Current daily basal insulin requirement above or equal to 0.2 to below or equal to 0.8 (I)U/kg/day and current total daily insulin treatment below 1.2 (I)U/kg/day
  • Fasting C-peptide below 0.3 nmol/L

Exclusion Criteria:

  • The receipt of any investigational medicinal product within the last 3 months prior to the start of this trial (screening)
  • Significant blood loss (due to donation, surgery or trauma) of more than 500 mL within 3 months prior to the start of this trial (screening) or participating in any other trial involving blood sampling within the last 2 months before the start of this trial (screening)
  • Use of any prescription (see specification below for Trial Part 2) or non-prescription medication, including herbal products and non-routine vitamins, within the last 2 weeks before the start of the trial (screening) that will interfere with the pharmacokinetics of insulin 287, as judged by the investigator in agreement with the sponsor. Routine vitamins and occasional use judged by the investigator in agreement with the sponsor. Routine vitamins and occasional use of paracetamol is permitted up to 48 hours prior to dosing
  • History of alcoholism or drug abuse (within the last 2 years), or positive result of alcohol or drug screening test
  • 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
  • Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the investigator
  • Excessive consumption of a diet deviating from a normal diet as judged by the investigator
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation in the trial
  • Vulnerable subjects (e.g. persons kept in detention)
  • Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the trial
  • ADDITIONAL KEY EXCLUSION CRITERIA TRIAL PART 2 (subjects with type 1 diabetes):
  • Current treatment with statins, systemic (oral, intravenous or inhaled) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, thyroid hormones, growth hormone and other drugs, which may interfere with glucose metabolism
  • 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: decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time, or acute myocardial infarction at any time, or angina pectoris within the last 12 months before start of this trial (screening)
  • Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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 NCT01730014
Other Study ID Numbers  ICMJE NN1436-3955
2011-005172-41 ( EudraCT Number )
U1111-1125-2924 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novo Nordisk A/S
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novo Nordisk A/S
Original Study Sponsor  ICMJE Same as current
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 July 2013

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