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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2D Semaglutide Cohort | 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 | Adults with obesity, defined as BMI equal or greater than 27 kg/m2, prescribed semaglutide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide (SEMA) | Drug | participants who initiate semaglutide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 1 year |
| Change in HbA1c- 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Endpoint (3 Years) |
| Proportion of individuals who achieve HbA1c ≤ 7.0% |
Inclusion Criteria:
T2D Cohort:
Obesity Cohort:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Chu, PhD | Contact | (416) 645-2929 | lisa.chu@lmc.ca | |
| giovana Romero, Msc | Contact | (416) 645-2929 | giovana.romero@lmc.ca |
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This is an observational study using data retrieved from a national diabetes registry. IPD will not be shared.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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% | 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% | 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% | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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 | 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% | 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% | 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% | 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 | 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 | 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 | 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 | 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 | 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) |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |