Clinical Trials at Novo Nordisk

• Overview
• Clinical trial registry
• Trial results
• About clinical research
• Glossary

About clinical research

• Clinical research ethics
• Information for patients
• Questions & Answers
• Our way of disclosure
• Our Clinical Trials
• Results from our trials

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Our way of disclosure

National and international guidelines regulate the conduct and disclosure of clinical research activities. Novo Nordisk complies with these regardless of where the trial is conducted.
Novo Nordisk is committed to publicly registering protocol information for Novo Nordisk sponsored phase 1-4 interventional trials and observational studies no later than 21 days after enrolment of the first trial participant. Results for trials for a marketed product are made available in the format of an ICH-E3 synopsis no later than one year after trial completion (last patient last visit).

The timelines and scope for disclosing trial information and results are listed in detail in our company standard:

Novo Nordisk Code of Conduct for Clinical Trial Disclosure

This code of conduct was developed to ensure transparency on how clinical research information is disclosed. It is based on the international and national requirements listed below:

• Food and Drug Administration Amendments Act of 2007, section 801
• Food and Drug Administration Modernization Act of 1997, section 113
• International Committee of Medical Journal Editors (ICMJE)
• Joint position on the disclosure of clinical trial information via clinical trial registries and databases
• State of Maine: Prescription Drug Clinical Trial Reporting
• Pharmaceutical Research and Manufacturers of America (PhRMA)