Diabetes (DM), Obesity (Disorder), Type 2 Diabetes
Conditions
Keywords
semaglutide, T2D, AHA, HbA1c
Brief 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. 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.
Interventions
participants who initiate semaglutide
Sponsors
LMC Diabetes & Endocrinology Ltd.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c- 3 Years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c- 1 Year | 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 |
| Change in HbA1c- 2 Years | 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 |
| Proportion of individuals who achieve HbA1c ≤ 7.0% - 1 Year | 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 |
| Proportion of individuals who achieve HbA1c ≤ 7.0%- 2 Years | 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 |
| Proportion of individuals who achieve HbA1c ≤ 7.0% - 3 Years | 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 |
| Change in body weight- 1 Year | 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 |
| Change in body weight- 2 Years | 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 |
| Change in body weight- 3 Years | 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 |
| Percent body weight loss ≥ 5% - 1 Year | 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 |
| Percent body weight loss ≥ 5% - 2 Years | 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 |
| Percent body weight loss ≥ 5% - 3 Years | 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 |
| Percent body weight loss ≥ 10% - 1 Year | 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 |
| Percent body weight loss ≥ 10% - 2 Years | 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 |
| Percent body weight loss ≥ 10% - 3 Years | 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 |
| Percent body weight loss ≥ 15% - 1 Year | 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 |
| Percent body weight loss ≥ 15%- 2 Years | 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 |
| Percent body weight loss ≥ 15%- 3 Years | 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 |
| Change in BMI- 1 Year | 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 |
| Change in BMI- 2 Years | 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 |
| Change in BMI- 3 Years | 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 |
| Change in Waist Circumference- 1 Year | 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 |
| Change in Waist Circumference- 2 Years | 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 |
| Change in Waist Circumference- 3 Years | 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 |
| Change in Blood Pressure- 1 Year | 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 |
| Change in Blood Pressure- 2 Years | 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 |
| Change in Blood Pressure- 3 Years | 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 |
| Change in eGFR- 1 Year | 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 |
| Change in eGFR- 2 Years | 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 |
| Change in eGFR- 3 Years | 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 |
| Proportion of individuals with ≥ 50% decline in eGFR- 1 Year | 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 |
| Proportion of individuals with ≥ 50% decline in eGFR- 2 Years | 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 |
| Proportion of individuals with ≥ 50% decline in eGFR- 3 Years | 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 |
| Change in uACR- 1 year | 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 |
| Change in uACR- 2 years | 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 |
| Change in uACR- 3 Years | 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 |
| Change in ALT- 1 Year | 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 |
| Change in ALT- 2 Years | 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 |
| Change in ALT- 3 Years | 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 |
| Change in Lipids- 1 Year | 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 |
| Change in Lipids- 2 Years | 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 |
| Change in Lipids- 3 Years | 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 |
| Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 1 Year | 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 |
| Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 2 Years | 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 |
| Change in number of non-insulin AHAs, excluding GLP-1 based therapies- 3 Years | 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 |
| Number of non-semaglutide GLP-1-based therapies- 1 Year | 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 |
| Number of non-semaglutide GLP-1-based therapies- 2 Years | 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 |
| Number of non-semaglutide GLP-1-based therapies- 3 Years | 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 |
| Change in insulin use- 1 Year | 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 |
| Change in Insulin- 2 Years | 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 |
| Change in Insulin- 3 Years | 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 |
| Change in TDD of insulin- 1 Year | 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 |
| Change in TDD of insulin- 2 Years | 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 |
| Change in TDD of insulin- 3 Years | 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 |
| Incidence of non-acetylsalicylic acid antiplatelet use | 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 |
| Percent body weight loss ≥ 5% | 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) |
| Percent body weight loss ≥ 10% | 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) |
| Percent body weight loss ≥ 15% | 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) |
| Body Weight | 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) |
| Waist Circumference | 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) |
| HbA1c | 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) |
| Percent of new onset pre-diabetes | 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) |
| Percent of new onset T2D | 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) |
| Blood Pressure | 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) |
| eGFR | 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) |
| uACR | 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) |
| ALT | 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) |
| BMI | 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) |
| Lipids | 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) |
Contacts
CONTACTLisa Chu, PhD
CONTACTgiovana Romero, Msc
Outcome results
None listed