Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are an injectable, non-insulin therapy for patients with type 2 diabetes (T2D). Semaglutide (Ozempic®) is the newest GLP-1 RA to become available in Canada in 2018, and is administered subcutaneously once-weekly. In clinical trials, semaglutide has been superior to placebo and other antihyperglycemic agents in HbA1c reduction and body weight loss. However, there is little real-world evidence available on the effectiveness of semaglutide in real-world clinical practice. To better understand the effectiveness of semaglutide on clinical outcomes in a real-world setting, this retrospective cohort study will use the Canadian LMC Diabetes Registry to examine the effects of semaglutide on glycemic control, body weight, and other clinical outcomes in patients with T2D who initiate once-weekly semaglutide as part of usual clinical care in a diabetes specialist practice group in Canada.
Study Type
OBSERVATIONAL
Enrollment
1,133
Prescription for semaglutide as part of usual clinical practice
LMC Diabetes & Endocrinology
Toronto, Ontario, Canada
Change in HbA1c
Change in HbA1c (%) between baseline and last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Change in body weight
Change in body weight (kg) between baseline and last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Change in body mass index (BMI)
Change in BMI (kg/m2) between baseline and last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Change in systolic blood pressure (SBP)
Change in SBP (mmHg) between baseline and last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Change in diastolic blood pressure (DBP)
Change in DBP (mmHg) between baseline and last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Change in triglycerides
Change in triglycerides (mmol/L) between baseline and last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Change in LDL cholesterol
Change in LDL cholesterol (mmol/L) between baseline and last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Change in non-HDL cholesterol
Change in non-HDL cholesterol (mmol/L) between baseline and last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Change in estimated glomerular filtration rate (eGFR)
Change in eGFR (mL/min/1.73 m2) between baseline and last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Change in alanine amino transaminase (ALT)
Change in ALT (U/L) between baseline and last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Proportion of patients who report ≥ 1 weekly incidence of any hypoglycemia
Analyses will also be stratified by sulfonylurea (SU) versus non-SU use, and insulin versus non-insulin use
Time frame: 3 to 6 months
Proportion of patients who report ≥ 1 yearly incidence of severe hypoglycemia
Analyses will also be stratified by SU versus non-SU use, and insulin versus non-insulin use
Time frame: 3 to 6 months
Proportion of patients who achieve HbA1c ≤7.0%
HbA1c will be the last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Proportion of patients who achieve HbA1c ≤8.0%
HbA1c will be the last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Proportion of patients who achieve HbA1c reduction ≥0.5%
HbA1c will be the last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Proportion of patients who achieve HbA1c reduction ≥1.0%
HbA1c will be the last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Proportion of patients who achieve weight loss ≥5%
Weight will be the last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
Proportion of patients who achieve weight loss ≥10%
Weight will be the last measured value at 3 to 6 months follow-up
Time frame: 3 to 6 months
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