- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730014
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
July 30, 2013 updated by: Novo Nordisk A/S
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0148-0000-0287 in Healthy Subjects and in Subjects With Type 1 Diabetes
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Neuss, Germany, 41460
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trial part 1
|
In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously.
In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously.
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.
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.
|
Experimental: Trial part 2, treatment A
|
In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously.
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.
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.
|
Experimental: Trial part 2, treatment B
|
In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events (AE)
Time Frame: From trial product administration until completion of the post-treatment follow-up visit at Day 37
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From trial product administration until completion of the post-treatment follow-up visit at Day 37
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of hypoglycaemic episodes
Time Frame: From trial product administration until completion of the post-treatment follow-up visit at Day 37
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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
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From dosing visit to infinity calculated from a 0-36 days NNC0148-0287 serum concentration-time-curve based on 43 sampling time points
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Cmax, the maximum serum insulin 287 concentration
Time Frame: Observed (within 0-36 days)
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Observed (within 0-36 days)
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tmax, the time for maximum serum insulin 287 concentration
Time Frame: Within 0-36 days
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Within 0-36 days
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Average morning fasting blood glucose (FBG) concentration
Time Frame: From Day 2 to Day 8
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From Day 2 to Day 8
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Average morning fasting serum C-peptide concentration
Time Frame: From Day 2 to Day 8
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From Day 2 to Day 8
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Average morning fasting serum free fatty acid (FFA) concentration
Time Frame: From Day 2 to Day 8
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From Day 2 to Day 8
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Area under the glucose infusion rate (GIR)-time curve
Time Frame: At Day 1-2, 4-5, or 7-8
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At Day 1-2, 4-5, or 7-8
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The maximal GIR (glucose infusion rate) observed
Time Frame: At Day 1-2, 4-5, or 7-8
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At Day 1-2, 4-5, or 7-8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
November 6, 2012
First Submitted That Met QC Criteria
November 14, 2012
First Posted (Estimate)
November 21, 2012
Study Record Updates
Last Update Posted (Estimate)
July 31, 2013
Last Update Submitted That Met QC Criteria
July 30, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN1436-3955
- 2011-005172-41 (EudraCT Number)
- U1111-1125-2924 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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