Diabetes (DM)SEMA-CKMNCT07424430
Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes
An observational study of Diabetes (DM) and Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (DM), Type 2 Diabetes, Obesity (Disorder)
- What is being tested?
- Semaglutide (SEMA)
- How many people
- 3,392 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2026to 28 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Canadian Retrospective Study Evaluating Longitudinal SEMAglutide Use on Cardio-Kidney-Metabolic Outcomes
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.
- Conditions
- Diabetes (DM), Type 2 Diabetes, Obesity (Disorder)
- Being tested
- Semaglutide (SEMA)
- Keywords
- semaglutide, T2D, AHA, HbA1c
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (SEMA)Drug
participants who initiate semaglutide
| Study group | Role | What they receive |
|---|---|---|
| T2D Semaglutide Cohort | Adults with T2D prescribed semaglutide Receives: Drug: Semaglutide (SEMA) | |
| T2D other AHA cohort | Adults with T2D prescribed antihyperglycemic medication beside semaglutide including sulfonylurea, DPP4i, and/or SGLT2i | |
| Obesity Semaglutide Cohort | Adults with obesity, defined as BMI equal or greater than 27 kg/m2, prescribed semaglutide Receives: Drug: Semaglutide (SEMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 3 Years
Secondary outcomes (68)
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
Measured: Baseline to 1 year
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
Measured: Baseline to 2 Years
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
Measured: Baseline to 1 Year
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
Measured: Baseline to 2 Years
Proportion of individuals who achieve HbA1c ≤ 7.0% - 3 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 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in body weight- 1 Year
comparing the change in body weight (kg) 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
Measured: Baseline to 1 Year
Change in body weight- 2 Years
comparing the change in body weight (kg) 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
Measured: Baseline to 2 Years
Change in body weight- 3 Years
comparing the change in body weight (kg) between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Percent body weight loss ≥ 5% - 1 Year
comparing the percent body weight loss ≥ 5% 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
Measured: Baseline to 1 Year
Percent body weight loss ≥ 5% - 2 Years
comparing the percent body weight loss ≥ 5% 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
Measured: Baseline to 2 Years
Percent body weight loss ≥ 5% - 3 Years
comparing the percent body weight loss ≥ 5% between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Percent body weight loss ≥ 10% - 1 Year
comparing the percent body weight loss ≥ 10% 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
Measured: Baseline to 1 Year
Percent body weight loss ≥ 10% - 2 Years
comparing the percent body weight loss ≥ 10% 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
Measured: Baseline to 2 Years
Percent body weight loss ≥ 10% - 3 Years
comparing the percent body weight loss ≥ 10% between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Percent body weight loss ≥ 15% - 1 Year
comparing the percent body weight loss ≥ 15% 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
Measured: Baseline to 1 Year
Percent body weight loss ≥ 15%- 2 Years
comparing the percent body weight loss ≥ 15% 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
Measured: Baseline to 2 Years
Percent body weight loss ≥ 15%- 3 Years
comparing the percent body weight loss ≥ 15% between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in BMI- 1 Year
comparing the change in BMI (kg/m^2) 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
Measured: Baseline to 1 Year
Change in BMI- 2 Years
comparing the change in BMI (kg/m^2) 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
Measured: Baseline to 2 Years
Change in BMI- 3 Years
comparing the change in BMI (kg/m^2) between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in Waist Circumference- 1 Year
comparing the change in waist circumference (cm) 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
Measured: Baseline to 1 Year
Change in Waist Circumference- 2 Years
comparing the change in waist circumference (cm) 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
Measured: Baseline to 2 Years
Change in Waist Circumference- 3 Years
comparing the change in waist circumference (cm) between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in Blood Pressure- 1 Year
comparing the change in blood pressure 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
Measured: Baseline to 1 Year
Change in Blood Pressure- 2 Years
comparing the change in blood pressure 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
Measured: Baseline to 2 Years
Change in Blood Pressure- 3 Years
comparing the change in blood pressure between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 year in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in eGFR- 1 Year
comparing the change in eGFR (ml/min1.73m^2) 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
Measured: Baseline to 1 Year
Change in eGFR- 2 Years
comparing the change in eGFR (ml/min1.73m^2) 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
Measured: Baseline to 2 Years
Change in eGFR- 3 Years
comparing the change in eGFR (ml/min1.73m^2) between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Proportion of individuals with ≥ 50% decline in eGFR- 1 Year
comparing the proportion of individuals with ≥ 50% decline in eGFR 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
Measured: Baseline to 1 Year
Proportion of individuals with ≥ 50% decline in eGFR- 2 Years
comparing the proportion of individuals with ≥ 50% decline in eGFR 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
Measured: Baseline to 2 Years
Proportion of individuals with ≥ 50% decline in eGFR- 3 Years
comparing the proportion of individuals with ≥ 50% decline in eGFR between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in uACR- 1 year
comparing the change in uACR (mg/mmol) 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
Measured: Baseline to 1 Year
Change in uACR- 2 years
comparing the change in uACR (mg/mmol) 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
Measured: Baseline to 2 Years
Change in uACR- 3 Years
comparing the change in uACR (mg/mmol) between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in ALT- 1 Year
comparing the change in ALT (U/L) 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
Measured: Baseline to 1 Year
Change in ALT- 2 Years
comparing the change in ALT (U/L) 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
Measured: Baseline to 2 Years
Change in ALT- 3 Years
comparing the change in ALT (U/L) between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in Lipids- 1 Year
comparing the change in lipids (triglycerides, low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], total cholesterol) 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
Measured: Baseline to 1 Year
Change in Lipids- 2 Years
comparing the change in lipids (triglycerides, low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], total cholesterol) 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
Measured: Baseline to 2 Years
Change in Lipids- 3 Years
comparing the change in lipids (triglycerides, low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], total cholesterol) between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 1 Year
comparing the change in the number of non-insulin AHAs, excluding GLP-1 based therapies 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
Measured: Baseline to 1 Year
Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 2 Years
comparing the change in the number of non-insulin AHAs, excluding GLP-1 based therapies 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
Measured: Baseline to 2 Years
Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 3 Years
comparing the change in the number of non-insulin AHAs, excluding GLP-1 based therapies between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Number of non-semaglutide GLP-1-based therapies- 1 Year
comparing the number of non-semaglutide GLP-1-based therapies 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
Measured: Baseline to 1 Year
Number of non-semaglutide GLP-1-based therapies- 2 Years
comparing the number of non-semaglutide GLP-1-based therapies 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
Measured: Baseline to 2 Years
Number of non-semaglutide GLP-1-based therapies- 3 Years
comparing the number of non-semaglutide GLP-1-based therapies between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in insulin use- 1 Year
comparing the change in insulin use (none, basal only, basal-bolus) 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
Measured: Baseline to 1 Year
Change in Insulin- 2 Years
comparing the change in insulin use (none, basal only, basal-bolus) 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
Measured: Baseline to 2 Years
Change in Insulin- 3 Years
comparing the change in insulin use (none, basal only, basal-bolus) between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Change in TDD of insulin- 1 Year
comparing the change in TTD of insulin (U) 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
Measured: Baseline to 1 Year
Change in TDD of insulin- 2 Years
comparing the change in TTD of insulin (U) 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
Measured: Baseline to 2 Years
Change in TDD of insulin- 3 Years
comparing the change in TTD of insulin (U) between adults with T2D who initiated semaglutide compared with adults with T2D who initiated other AHAs at 3 years in the kidney, liver and cardiovascular sub-cohorts
Measured: Baseline to 3 Years
Incidence of non-acetylsalicylic acid antiplatelet use
comparing the incidence of non-acetylsalicylic acid antiplatelet use between adults with T2D treated with 1 or more years of semaglutide and adults with T2D treated with 1 or more years of other AHAs in the cardiovascular sub-cohort
Measured: Baseline to Endpoint
Percent body weight loss ≥ 5%
Comparing the percent body weight loss ≥ 5% in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
Percent body weight loss ≥ 10%
Comparing the percent body weight loss ≥ 10% in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
Percent body weight loss ≥ 15%
Comparing the percent body weight loss ≥ 15% in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
Body Weight
Comparing body weight (kg) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
BMI
Comparing BMI (km/m^2) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
Waist Circumference
Comparing the waist circumference (cm) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
HbA1c
Comparing HbA1c (%) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
Percent of new onset pre-diabetes
Comparing the percent of new onset pre-diabetes (%) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
Percent of new onset T2D
Comparing the percent of new onset T2D (%) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
Blood Pressure
Comparing blood pressure in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
eGFR
Comparing eGFR (ml/min1.73m^2) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 year
uACR
Comparing uACR (mg/mmol) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
ALT
Comparing ALT (U/L) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
Lipids
Comparing lipids (triglycerides, LDL-C, HDL-C , total cholesterol) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
Measured: Baseline to 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start20 Feb 2026
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424430
- Sponsor's protocol ID
- SEMA-CKM
- Acronym
- SEMA-CKM
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an observational study using data retrieved from a national diabetes registry. IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Canadian Retrospective Study Evaluating Longitudinal SEMAglutide Use on Cardio-Kidney-Metabolic Outcomes
- ClinicalTrials.gov ID
- NCT07424430
- Acronym / sponsor ID
- SEMA-CKM / SEMA-CKM
- Conditions
- Diabetes (DM), Type 2 Diabetes, Obesity (Disorder)
- Keywords
- semaglutide, T2D, AHA, HbA1c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,392 participants (actual)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T2D Semaglutide Cohort | – | Drug: Semaglutide (SEMA)Adults with T2D prescribed semaglutide |
| T2D other AHA cohort | – | –Adults with T2D prescribed antihyperglycemic medication beside semaglutide including sulfonylurea, DPP4i, and/or SGLT2i |
| Obesity Semaglutide Cohort | – | Drug: Semaglutide (SEMA)Adults with obesity, defined as BMI equal or greater than 27 kg/m2, prescribed semaglutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide (SEMA)participants who initiate semaglutide | Drug | Obesity Semaglutide Cohort, T2D Semaglutide Cohort |
Primary outcome
Change in HbA1c- 3 Years
Time frame: Baseline 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
68 secondary outcomes
Change in HbA1c- 1 Year
Time frame: Baseline to 1 year
Change in HbA1c- 2 Years
Time frame: Baseline to 2 Years
Proportion of individuals who achieve HbA1c ≤ 7.0% - 1 Year
Time frame: Baseline to 1 Year
Proportion of individuals who achieve HbA1c ≤ 7.0%- 2 Years
Time frame: Baseline to 2 Years
Proportion of individuals who achieve HbA1c ≤ 7.0% - 3 Years
Time frame: Baseline to 3 Years
Change in body weight- 1 Year
Time frame: Baseline to 1 Year
Change in body weight- 2 Years
Time frame: Baseline to 2 Years
Change in body weight- 3 Years
Time frame: Baseline to 3 Years
Percent body weight loss ≥ 5% - 1 Year
Time frame: Baseline to 1 Year
Percent body weight loss ≥ 5% - 2 Years
Time frame: Baseline to 2 Years
Percent body weight loss ≥ 5% - 3 Years
Time frame: Baseline to 3 Years
Percent body weight loss ≥ 10% - 1 Year
Time frame: Baseline to 1 Year
Percent body weight loss ≥ 10% - 2 Years
Time frame: Baseline to 2 Years
Percent body weight loss ≥ 10% - 3 Years
Time frame: Baseline to 3 Years
Percent body weight loss ≥ 15% - 1 Year
Time frame: Baseline to 1 Year
Percent body weight loss ≥ 15%- 2 Years
Time frame: Baseline to 2 Years
Percent body weight loss ≥ 15%- 3 Years
Time frame: Baseline to 3 Years
Change in BMI- 1 Year
Time frame: Baseline to 1 Year
Change in BMI- 2 Years
Time frame: Baseline to 2 Years
Change in BMI- 3 Years
Time frame: Baseline to 3 Years
Change in Waist Circumference- 1 Year
Time frame: Baseline to 1 Year
Change in Waist Circumference- 2 Years
Time frame: Baseline to 2 Years
Change in Waist Circumference- 3 Years
Time frame: Baseline to 3 Years
Change in Blood Pressure- 1 Year
Time frame: Baseline to 1 Year
Change in Blood Pressure- 2 Years
Time frame: Baseline to 2 Years
Change in Blood Pressure- 3 Years
Time frame: Baseline to 3 Years
Change in eGFR- 1 Year
Time frame: Baseline to 1 Year
Change in eGFR- 2 Years
Time frame: Baseline to 2 Years
Change in eGFR- 3 Years
Time frame: Baseline to 3 Years
Proportion of individuals with ≥ 50% decline in eGFR- 1 Year
Time frame: Baseline to 1 Year
Proportion of individuals with ≥ 50% decline in eGFR- 2 Years
Time frame: Baseline to 2 Years
Proportion of individuals with ≥ 50% decline in eGFR- 3 Years
Time frame: Baseline to 3 Years
Change in uACR- 1 year
Time frame: Baseline to 1 Year
Change in uACR- 2 years
Time frame: Baseline to 2 Years
Change in uACR- 3 Years
Time frame: Baseline to 3 Years
Change in ALT- 1 Year
Time frame: Baseline to 1 Year
Change in ALT- 2 Years
Time frame: Baseline to 2 Years
Change in ALT- 3 Years
Time frame: Baseline to 3 Years
Change in Lipids- 1 Year
Time frame: Baseline to 1 Year
Change in Lipids- 2 Years
Time frame: Baseline to 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. This is an observational study using data retrieved from a national diabetes registry. IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes (DM) and Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c- 3 Years (time frame: Baseline to 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.