About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study populations will include adults with T2D prescribed semaglutide (T2D sema cohort) or other AHA (T2D other AHA cohort) including sulfonylurea, DPP4i, and/or SGLT2i, or adults with obesity, defined as BMI equal or greater 27 kg/m2, prescribed semaglutide (obesity sema cohort), who attend an LMC Diabetes \& Endocrinology clinic
Trial design
Cohort
Retrospective
Treatments tested in this trial
Semaglutide (SEMA)
Drugparticipants who initiate semaglutide
Treatment groups
Trial outcomes
Primary outcomes
Change in HbA1c- 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
Secondary outcomes
Change in HbA1c- 1 Year
Comparing the change in HbA1c between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 1 year in the kidney, liver and cardiovascular sub-cohorts
Change in HbA1c- 2 Years
Comparing the change in HbA1c between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 2 years in the kidney, liver and cardiovascular sub-cohorts
Proportion of individuals who achieve HbA1c ≤ 7.0% - 1 Year
comparing the proportion of individuals who achieve HbA1c ≤ 7.0% between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 1 year in the kidney, liver and cardiovascular sub-cohorts
Proportion of individuals who achieve HbA1c ≤ 7.0%- 2 Years
comparing the proportion of individuals who achieve HbA1c ≤ 7.0% between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 2 years in the kidney, liver and cardiovascular sub-cohorts
Other outcomes
HbA1c
Comparing HbA1c between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
Proportion of individuals who achieve HbA1c ≤ 7.0%
Comparing the proportion of individuals who achieve HbA1c ≤ 7.0% between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
Body Weight
Comparing body weight (kg) between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
Percent body weight loss ≥ 5%
Comparing percent body weight loss ≥ 5% between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
Locations
Sponsors and contacts
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