Database Linkage Study to Evaluate the Risk of Medullary Thyroid Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 93,600,000
- Locations
- 1
- Primary Endpoint
- Time to first occurence of Medullary Thyroid Carcinoma (MTC)
Study Overview
Brief Summary
This is a database linkage study utilizing real-world data (RWD) to determine whether certain medicines used to treat type 2 diabetes (T2D) and support weight management (called GLP-1 RAs (Glucagon-like peptide-1 receptor agonists )) are linked to an increased risk of a rare cancer called medullary thyroid carcinoma (MTC). The purpose of this study is to compare how often medullary thyroid cancer occurs in people taking these medicines versus those taking other similar treatments. This study will use dispensed prescription claims and State Cancer Registry data to assess the risk of MTC.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older during the year of index (date of qualifying medication)
- •In addition to index medication, greater than or equal to (≥) 1 dispensed medication (any class) within 24 months prior to the index date1
- •≥1 dispensed medication (any class) after the index date and within 12 months of index date (12-month post-index period)
- •No evidence of cohort qualifying medication during 12-month before the index date
- •Reside in the US, including the District of Columbia (DC) during the study period
- •No missing values for year of birth
Exclusion Criteria
- •Patients with a diagnosis of MTC in the linked SCR data before their index date will not be included in the study.
Arms & Interventions
T2D Active Comparator 2 Cohort
Participants will be included in this cohort if they fill at least one dispensed prescription for any antidiabetic medications (including SGLT2 or DPP-4 inhibitors), other than LA GLP-1 RA therapies during the study patient selection period with no evidence of the cohort qualifying medication during the prior 12-month lookback period.
Intervention: No treatment given (Other)
Overweight/Obesity Active Comparator Cohort
Participants will be included in this cohort if they fill at least one dispensed prescription for anti-obesity medications, other than LA GLP-1 RA therapies during the study patient selection period with no evidence of the cohort qualifying medication during the prior 12-month lookback period.
Intervention: No treatment given (Other)
T2D Active Comparator 1 Cohort
Participants will be included in this cohort if they fill at least one dispensed prescription for SGLT2 or DPP-4 inhibitors during the study patient selection period with no evidence of SGLT2 or DPP-4 inhibitors and without LA GLP-1 RA use during the prior 12-month lookback period.
Intervention: No treatment given (Other)
Long-acting GLP-1 RA Exposed Cohort
Participants will be eligible for inclusion in this cohort if they have at least one dispensed prescription for a LA GLP-1 RA therapy during the study patient selection period.
Intervention: No treatment given (Other)
Outcomes
Primary Outcomes
Time to first occurence of Medullary Thyroid Carcinoma (MTC)
Time Frame: From day 1 up to 15 years
Measured in number of days.
Secondary Outcomes
No secondary outcomes reported