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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLMC Diabetes & Endocrinology Ltd.

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Semaglutide (SEMA)

    Drug

    participants who initiate semaglutide

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: T2D Semaglutide Cohort1 intervention
Group B: T2D other AHA cohort0 interventions
Group C: Obesity Semaglutide Cohort1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline to 3 Years

Secondary outcomes

1

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

Time frame
Baseline to 1 year
2

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

Time frame
Baseline to 2 Years
3

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

Time frame
Baseline to 1 Year
4

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

Time frame
Baseline to 2 Years

Other outcomes

1

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

Time frame
Baseline to Endpoint (3 Years)
2

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

Time frame
Baseline to Endpoint (3 Years)
3

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

Time frame
Baseline to Endpoint (3 Years)
4

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

Time frame
Baseline to Endpoint (3 Years)

Locations

This trial has no locations.

Sponsors and contacts

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