Clinical trial

Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes

Opening soon · Not applicable · 0 countries · Registry ID NCT07424430

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionDiabetes (DM), Type 2 Diabetes, Obesity (Disorder)

Full registry 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)

Treatments and study arms

Semaglutide (SEMA)

Drug

participants who initiate semaglutide

Primary outcomes

Change in HbA1c- 3 YearsBaseline to 3 Years

The primary outcome measure is investigating the change in HbA1c from baseline to 3 years (± 90 days) among adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs

Study locations

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No public site location was included in this record. Check the original registry for updates.