Novo Nordisk ensures that protocol information for all Novo Nordisk sponsored trials is registered in publicly accessible databases according to the applicable national and international requirements, before recruitment of any trial participants.
Read the full details in the Novo Nordisk Code of Conduct for Clinical Study Disclosure.
As a research-based pharmaceutical company, Novo Nordisk recognises the importance of publicly registering clinical trials and non-interventional studies and making their results available.
Novo Nordisk is committed to disclosure of clinical trials and non-interventional studies in compliance with the Declaration of Helsinki, and applicable laws and guidelines.
Investigator-sponsored studies including Novo Nordisk products are outside the scope of this code of conduct as conduct and registration of such studies is the responsibility of the sponsor and not Novo Nordisk.
Novo Nordisk is committed to publicly register protocol information for Novo Nordisk sponsored clinical trials and non-interventional studies within the timeframe, in the format and in the registries specified by national laws or regulations. The primary registers used to provide protocol information are www.ClinicalTrials.gov and the EU CTR; in addition the protocol information is also accessible via www.novonordisk-trials.com.
Novo Nordisk is committed to the communication of results for Novo Nordisk sponsored clinical trials and non-interventional studies to the public. The timing and format, as well as location of clinical trial data disclosure is dictated by national legislation. The primary sites used to provide results are www.ClinicalTrials.gov and the EU CTR; in addition information is also accessible via www.novonordisk-trials.com.
Novo Nordisk is committed to provide consistent information across registries, and thus increase the transparency of clinical studies sponsored by our company. Novo Nordisk supports the WHO initiative of adding a unique study identifier to clinical trials, regardless of whether they are subject to disclosure in order to track a clinical trial across national registries.
Some registries extract information from various sources. Novo Nordisk cannot guarantee that these registries are properly maintained and the information updated, and disclaims any liability for information thus collected. With respect to the official up-to-date trial information, references are made to Novo Nordisk’s www.novonordisk-trials.com.
In addition to the information outlined above, Novo Nordisk is gradually making ICH-defined Clinical Study Reports publicly available for trials completed after 1 January 2006 on product indications that have been approved in the EU and US.
The CSRs are made available as follows:
CSRs will gradually be made available.
Moreover, summary reports from discontinued product development projects will be published within 12 months of the public announcement of project discontinuation.
The CSR is a standardised format following ICH guidelines that is used for regulatory submission and is therefore, a document that demonstrates the outcomes of clinical trials in a way that is complete, representative and comparable. The CSRs consist of three main parts: A body of text, a longer section of tables and figures and finally a series of appendices with detailed data including individual patient and clinical study site data. As an example, these parts can be 200 pages, 600 pages and 4200 pages, respectively.
We also share the anonymised dataset with qualified researchers upon request, see We share anonymised data with other researchers.