Real-world Health Outcomes in Canadian Patients Using Semaglutide

Study Overview
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Brief Summary
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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.

Official Title
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Semaglutide in Patients With Type 2 Diabetes: Real-world Analysis in the Canadian LMC Diabetes Registry: The SPARE Study

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Semaglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First prescription for semaglutide between Feb 1 2018 and Feb 1 2019 Age ≥ 18 years at medication index date Clinical diagnosis of type 2 diabetes for greater than six months ≥ one HbA1c measurement at baseline and at follow-up ≥ one follow-up visit post index date Informed consent for medical data to be used for research purposes Exclusion Criteria: Clinical diagnosis of type 1 diabetes Recent eGFR <40 ml/min/1.73m2 Documented history of bariatric surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Semaglutide|Prescription for semaglutide as part of usual clinical practice|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | Change in HbA1c (%) between baseline and last measured value at 3 to 6 months follow-up | 3 to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Change in body weight (kg) between baseline and last measured value at 3 to 6 months follow-up | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 3 to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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semaglutide, retrospective study, hemoglobin A1c, body weight