Completed Clinical Studies
We publish the summaries of study results from clinical studies which have been completed after 1 January 2006.
Novo Nordisk shares information about clinical studies and their results in accordance with international and national laws and guidelines. Enabling access to study information for researchers, study participants and others who may be interested is an important contribution to clinical transparency, overall scientific excellence and improved lifesaving medicinal products.
Study registration
We register information about our clinical studies before starting recruitment of study participants in publicly accessible clinical trial registries, which are an important source of information for researchers, medical doctors and patients. We register studies in national registries as required by local law and also register all studies in the public US registry ClinicalTrials.gov. For studies with at least one site in the EU, we submit the study application to the European Clinical Trials Database. Information is made publicly available via the Clinical Trials in the European Union - EMA register. European non-interventional post-authorisation safety studies are also registered in the publicly accessible HMA-EMA Catalogues of real-world data sources and studies.
Disclosure of study results in public registers
We disclose clinical study results in accordance with international and national laws and guidelines. Results from phase 2–4 studies are submitted to ClinicalTrials.gov following US FDA rules. For studies with EU sites we submit results to the European Clinical Trials Database, information is made publicly available according to the EU Clinical Trials Regulation via the Clinical Trials in the European Union - EMA. For studies which are registered in the HMA-EMA Catalogues of real-world data sources and studies we upload redacted results summaries within 12 months of study completion.
Disclosure of results documents on the Novo Nordisk Trials website
We publish the summaries of study results from all clinical studies which have been completed after 1 January 2006 and layperson summaries (easy -to-read) from all Novo Nordisk clinical phase 1-4 studies that have been completed on 1 January 2016 or later on the Novo Nordisk Trials website. Timing depends on study type and phase:
- For phase 1 studies, the summaries of study results and layperson summaries are published after the product/indication has obtained marketing authorisation in the EU and US.
- For phase 2 to 4 studies which are conducted before EU and US marketing authorisation the summaries of study results and the layperson summaries are published when results tables are submitted to ClinicalTrials.gov.
- For studies which are conducted after the EU and US marketing authorisation the summaries of study results and the layperson summaries are published 12 months after the study has been completed.
Disclosure of study results from discontinued projects
If a development program is stopped and no other organization continues it, we publish the project’s study summary on the Novo Nordisk Trials website within 12 months after the public announcement of discontinuation or after study completion, whichever is later.
Publication of study results in scientific forums
We aim to present and publish results in scientific forums regardless of clinical study outcomes. Novo Nordisk seeks to present key findings at conferences and to publish in peer reviewed medical journals, following guidelines from organizations such European Federation of Pharmaceutical Industries and Associations (EFPIA), International Committee of Medical Journal Editors (ICMJE), Pharmaceutical Research and Manufacturers of America (PhRMA), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and others. We generally aim to submit important results for conference or journal consideration within 12–18 months after study completion.
Access to anonymised clinical study data
We support secondary use of data from Novo Nordisk‑sponsored clinical studies for legitimate scientific research in accordance with the joint EFPIA‑PhRMA Principles for Responsible Clinical Trial Data Sharing.
Access to anonymised individual participant‑level data and redacted study documents may be requested for Novo Nordisk‑sponsored phase 2–4 studies with study start after January 2014, provided the product’s indications are approved for marketing in both the EU and the US.
Access can be considered for scientifically valid research proposals if the use respects the informed consent given by study participants, and the data can be sufficiently anonymised to protect personally identifiable information and safeguard participant privacy.
Novo Nordisk is a member of the Vivli global clinical research data sharing platform. Data access requests including the research proposal, the list of requested studies and data elements, the statistical analysis plan and the publication plan can be submitted through the Vivli data request process.
Anonymised data will be made available on the Vivli platform after completion of Novo Nordisk’s assessment and approval process and after signing the Vivli Data Use Agreement.
Researchers must agree to provisions, including without limitation:
- Not attempting to re identify participants and immediately notifying Novo Nordisk if re- identification is suspected
- Using the data only for the approved research purpose
- Not downloading or disclosing data to third parties
- Not using the data for commercial purposes
- Immediately reporting any health or safety concerns arising from analysis of Novo Nordisk data
- Publishing scientifically or medically important findings in peer reviewed journals
For more information, please contact dataaccess@novonordisk.com
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