Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04572165
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-02
First Post:
2020-09-30
Brief Title:
Epidemiological Assessment of the Risk for Pancreatic Cancer Associated With the Use of Semaglutide in Patients With Type 2 Diabetes - A Cohort Study Based on Nordic Registry Data
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
Epidemiological Assessment of the Risk for Pancreatic Cancer Associated With the Use of Semaglutide in Patients With Type 2 Diabetes - A Cohort Study Based on Nordic Registry Data
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate whether exposure to semaglutide influences the risk of pancreatic cancer in patients with type 2 diabetes This is achieved by estimating the risk of pancreatic cancer associated with semaglutide use as compared to use of other non-incretin antidiabetic drugs used at a similar stage as Ozempic or Rybelsus in the treatment of type 2 diabetes A multi-national non-interventional study based on health care data from Denmark Sweden and Norway is conducted covering the period 2018-2023 A cohort study design is used comparing new users of semaglutide with new users of other antidiabetic drugs used at a similar stage as Ozempic or Rybelsus in the treatment of type 2 diabetes active comparators Active comparators will include the following non-incretin antidiabetic agents sulphonylureas sodium-glucose co-transporter 2 inhibitors and insulin subdivided into i basal insulin only and ii basal bolus insulin or premix insulin Propensity scores are used to match new users of semaglutide with new users of active comparators National prescription- cancer- and patient registries are used to identify exposure to antidiabetic agents pancreatic cancer cases and covariates to be used in propensity score matching This study is a post-authorisation safety study PASS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUPAS37258 | REGISTRY | EU PAS Register | None |
| U1111-1214-6228 | OTHER | None | None |