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Completed
NCT07424430
Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes
Conditions: Diabetes (DM), Type 2 Diabetes, Obesity (Disorder)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 3392
Sponsor: LMC Diabetes & Endocrinology Ltd.
Location: LMC Diabetes & Endocrinology Ltd. Toronto Ontario
Summary
The goal of this study is to better understand the real-world effectiveness of semaglutide use on cardio-kidney-metabolic outcomes among adults with T2D and adults with obesity (without diabetes mellitus). This is a retrospective longitudinal analysis using the LMC Diabetes Registry. The primary outcome of the study is to evaluate the change in HbA1c between baseline to 3 years of follow-up among adults with T2D who initiated semaglutide compared to adults with T2D who initiated other AHAs, including sulfonylurea, dipeptidyl peptidase-4 inhibitors, and sodium-glucose cotransporter-2 inhibitors.
Eligibility Criteria
Inclusion Criteria:
T2D Cohort:
* A clinical diagnosis of T2D ≥ 1 year
* HbA1c ≥ 6.5% (pre-index date)
* Initiated semaglutide or other AHA(s) before January 1st, 2023\*
* Seen by an LMC endocrinologist in the last 18 months as of the query date
* ≥ one HbA1c value up to 6 months (+ 90 days) prior to index date
* Informed data consent for their medical record data to be used for research purposes
Obesity Cohort:
* 18 years or older
* BMI ≥ 27 kg/m2
* HbA1c \< 6.5% (pre-index date)
* Initiated semaglutide before January 1st, 2023\*
* Seen by an LMC endocrinologist in the last 18 months as of the query date
* ≥ one HbA1c value up to 6 months (± 90 days) prior to index date
* Informed data consent for their medical record data to be used for research purposes
Exclusion Criteria:
* Clinical diagnosis of type 1 diabetes/latent autoimmune diabetes in adults (LADA)
* Clinical diagnosis of T2D (obesity cohort only)
* Are pregnant at the time of semaglutide or other AHA initiation or became pregnant during follow-up period
* Documented history or family history of medullary thyroid carcinoma
* Participation in a research study with an Investigational Product
* eGFR \< 15 mL/min/1.73m2 at index date
* Use of non-semaglutide GLP-1-based medication for more than 6 months after the index date (T2D sema cohort and obesity sema cohort)
* Use of other AHA for more than 6 months after the index date within the first year of semaglutide use (T2D sema cohort and obesity sema cohort)
Source: ClinicalTrials.gov (NCT07424430). StuddyBuddy aggregates publicly available trial information.