Information for patients
Information on this site is general and not comprehensive. For specific advice, please consult your own physician. In the Clinical Trial Registry you may search trials in a given country or a specific therapy area. Please use the contact form to obtain information on who to contact to be considered for trial participation.
Please note that participation in observational studies is possible by invitation from a physician only.
Want to take part in a clinical trial?
In a clinical trial, the physician conducting the research decides if a patient can be enrolled. This is done according to the in- and exclusion criteria defined for the trial. To do this the physician must carry out:
- A detailed medical examination
- A review of the full medical history
A patient may participate in the trial after having been informed of all aspects of the trial and signing an informed consent form.
Patients with a health advantage of participating in a Novo Nordisk trial may be reimbursed for documented reasonable travelling expenses and loss of income. In trials with no health advantage for patients and healthy volunteers, participants can further be financially compensated for inconvenience/discomfort during the trial. All agreements on compensation should be described in the protocol and approved by the IRB/Ethical committee.
The conduct of clinical trials
Clinical trials are carefully designed to evaluate the effects of a medication, medical treatment or device in a group of volunteers. Clinical trials are an important step in the research and development process to make new medications available. These trials measure the ability of a medicinal product to treat a condition, its safety, and/or its possible side effects.
General information on clinical trials in diabetes can be found at the American Diabetes Association.
In clinical trials, a new treatment might be compared to the present standard treatment or no treatment by using placebo, if this is scientifically and ethically justified.
Participation in a clinical trial is always voluntary, based on an informed consent, with the ability to withdraw at any time without providing a reason.
All trial participants must provide voluntary informed consent after receiving appropriate information (verbally and in writing in their native language) that must include information about the risk of participating, research design and possible post-trial benefits.
Novo Nordisk strives to ensure that for example disabled people, children and adolescents or illiterates are not prevented from fully understanding the issues involved in participating in a clinical trial. No trial participants will be enrolled in any trial activity before informed consent procedures according to local regulations, Good Clinical Practice (GCP) and other regulations for trial participants have been met. When the patient is able, he or she will be asked to sign an informed consent form.
Risks/benefits in trial participation
According to the Good Clinical Practice (GCP) principles which all Novo Nordisk clinical trials follow, a trial should be initiated and continued only if the anticipated benefits justify the risks.