- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424430
Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes (SEMA-CKM)
February 13, 2026 updated by: LMC Diabetes & Endocrinology Ltd.
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisa Chu, PhD
- Phone Number: (416) 645-2929
- Email: lisa.chu@lmc.ca
Study Contact Backup
- Name: giovana Romero, Msc
- Phone Number: (416) 645-2929
- Email: giovana.romero@lmc.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
T2D Semaglutide Cohort
Adults with T2D prescribed semaglutide
|
participants who initiate semaglutide
|
|
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
|
participants who initiate semaglutide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline to 3 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in HbA1c- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 year
|
|
Change in HbA1c- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Proportion of individuals who achieve HbA1c ≤ 7.0% - 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Proportion of individuals who achieve HbA1c ≤ 7.0%- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Proportion of individuals who achieve HbA1c ≤ 7.0% - 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in body weight- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in body weight- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in body weight- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Percent body weight loss ≥ 5% - 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Percent body weight loss ≥ 5% - 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Percent body weight loss ≥ 5% - 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Percent body weight loss ≥ 10% - 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Percent body weight loss ≥ 10% - 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Percent body weight loss ≥ 10% - 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Percent body weight loss ≥ 15% - 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Percent body weight loss ≥ 15%- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Percent body weight loss ≥ 15%- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in BMI- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in BMI- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in BMI- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in Waist Circumference- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in Waist Circumference- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in Waist Circumference- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in Blood Pressure- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in Blood Pressure- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in Blood Pressure- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in eGFR- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in eGFR- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in eGFR- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Proportion of individuals with ≥ 50% decline in eGFR- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Proportion of individuals with ≥ 50% decline in eGFR- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Proportion of individuals with ≥ 50% decline in eGFR- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in uACR- 1 year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in uACR- 2 years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in uACR- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in ALT- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in ALT- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in ALT- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in Lipids- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in Lipids- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in Lipids- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Number of non-semaglutide GLP-1-based therapies- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Number of non-semaglutide GLP-1-based therapies- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Number of non-semaglutide GLP-1-based therapies- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in insulin use- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in Insulin- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in Insulin- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Change in TDD of insulin- 1 Year
Time Frame: Baseline to 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
|
Baseline to 1 Year
|
|
Change in TDD of insulin- 2 Years
Time Frame: Baseline to 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
|
Baseline to 2 Years
|
|
Change in TDD of insulin- 3 Years
Time Frame: Baseline to 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
|
Baseline to 3 Years
|
|
Incidence of non-acetylsalicylic acid antiplatelet use
Time Frame: Baseline to Endpoint
|
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
|
Baseline to Endpoint
|
|
Percent body weight loss ≥ 5%
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
Percent body weight loss ≥ 10%
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
Percent body weight loss ≥ 15%
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
Body Weight
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
BMI
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
Waist Circumference
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
HbA1c
Time Frame: Baseline to 1 Year
|
Comparing HbA1c (%) in the cohort of adults with obesity treated with semaglutide from the index date to 1 year of follow-up (± 90 days)
|
Baseline to 1 Year
|
|
Percent of new onset pre-diabetes
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
Percent of new onset T2D
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
Blood Pressure
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
eGFR
Time Frame: Baseline to 1 year
|
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)
|
Baseline to 1 year
|
|
uACR
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
ALT
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
|
Lipids
Time Frame: Baseline to 1 Year
|
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)
|
Baseline to 1 Year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c
Time Frame: Baseline to Endpoint (3 Years)
|
Comparing HbA1c between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
|
Baseline to Endpoint (3 Years)
|
|
Proportion of individuals who achieve HbA1c ≤ 7.0%
Time Frame: Baseline to Endpoint (3 Years)
|
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
|
Baseline to Endpoint (3 Years)
|
|
Body Weight
Time Frame: Baseline to Endpoint (3 Years)
|
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
|
Baseline to Endpoint (3 Years)
|
|
Percent body weight loss ≥ 5%
Time Frame: Baseline to Endpoint (3 Years)
|
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
|
Baseline to Endpoint (3 Years)
|
|
Percent body weight loss ≥ 10%
Time Frame: Baseline to Endpoint (3 Years)
|
Comparing percent body weight loss ≥ 10% between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
|
Baseline to Endpoint (3 Years)
|
|
Percent body weight loss ≥ 15%
Time Frame: Baseline to Endpoint (3 Years)
|
Comparing percent body weight loss ≥ 15% between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
|
Baseline to Endpoint (3 Years)
|
|
BMI
Time Frame: Baseline to Endpoint (3 Years)
|
Comparing BMI (kg/m^2) between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
|
Baseline to Endpoint (3 Years)
|
|
eGFR
Time Frame: Baseline to Endpoint (3 Years)
|
Comparing eGFR (ml/min1.73m^2)
between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
|
Baseline to Endpoint (3 Years)
|
|
Proportion of individuals with ≥ 50% decline in eGFR
Time Frame: Baseline to Endpoint (3 Years)
|
Comparing the proportion of individuals with ≥ 50% decline in eGFR between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
|
Baseline to Endpoint (3 Years)
|
|
uACR
Time Frame: Baseline to Endpoint (3 Years)
|
Comparing uACR (mg/mmol) between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
|
Baseline to Endpoint (3 Years)
|
|
ALT
Time Frame: Baseline to Endpoint (3 Years)
|
Comparing ALT (U/L) between patients with T2D initiating semaglutide and patients with T2D initiating other AHAs among GLP-1-naïve versus GLP-1-experienced subgroups
|
Baseline to Endpoint (3 Years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2026
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
February 13, 2026
First Submitted That Met QC Criteria
February 13, 2026
First Posted (Actual)
February 20, 2026
Study Record Updates
Last Update Posted (Actual)
February 20, 2026
Last Update Submitted That Met QC Criteria
February 13, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SEMA-CKM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is an observational study using data retrieved from a national diabetes registry.
IPD will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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