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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Prescription for semaglutide as part of usual clinical practice |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to addition of another diabetes therapy | Number of weeks until addition of another diabetes therapy | 3 to 6 months |
| Time to discontinuation of GLP-1 RA therapy | Number of weeks until discontinuation of semaglutide therapy in patients who discontinue semaglutide during the follow-up period |
Inclusion Criteria:
Exclusion Criteria:
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The study population will be patients with type 2 diabetes who initiate semaglutide between February 1, 2018 and February 1, 2019 as part of usual clinical care, and who are active patients at LMC Diabetes & Endocrinology.
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| Name | Affiliation | Role |
|---|---|---|
| Ronnie Aronson, MD | LMC Diabetes & Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMC Diabetes & Endocrinology | Toronto | Ontario | M4G 3E8 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| 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 |
| 3 to 6 months |
| Insulin dose at baseline and follow-up | Insulin dose will be evaluated in the subgroup of patients using insulin therapy | 3 to 6 months |
| HbA1c change in low dose therapy and high dose therapy subgroups | Low dose therapy (semaglutide 0.5 mg) and full dose therapy (semaglutide 1.0 mg) | 3 to 6 months |
| Body weight change in low dose therapy and high dose therapy subgroups | Low dose therapy (semaglutide 0.5 mg) and full dose therapy (semaglutide 1.0 mg) | 3 to 6 months |
| HbA1c change in patients who discontinue a dipeptidyl peptidase-4 inhibitor (DPP-4i) at baseline versus simple addition of semaglutide | 3 to 6 months |
| Body weight change in patients who discontinue a DPP-4i at baseline versus simple addition of semaglutide | 3 to 6 months |
| HbA1c change in patients who discontinue any diabetes therapy at baseline versus simple addition of semaglutide | 3 to 6 months |
| Body weight change in patients who discontinue any diabetes therapy at baseline versus simple addition of semaglutide | 3 to 6 months |
| HbA1c change in insulin users and non-insulin users | Based on insulin therapy used at baseline | 3 to 6 months |
| Weight change in insulin users and non-insulin users | Based on insulin therapy used at baseline | 3 to 6 months |
| HbA1c change in patients who have a 13-week follow-up versus a 26-week follow-up | 3 to 6 months |
| Weight change in patients who have a 13-week follow-up versus a 26-week follow-up | 3 to 6 months |
| HbA1c change in patients prescribed semaglutide as second line therapy (excluding insulin use) | In the subgroup of patients using one oral diabetes therapy at baseline | 3 to 6 months |
| Weight change in patients prescribed semaglutide as second line therapy (excluding insulin use) | In the subgroup of patients using one other diabetes therapy at baseline | 3 to 6 months |
| HbA1c change in patients prescribed semaglutide as third line therapy (excluding insulin use) | In the subgroup of patients using two oral diabetes therapies at baseline | 3 to 6 months |
| Weight change in patients prescribed semaglutide as third line therapy (excluding insulin use) | In the subgroup of patients using two oral diabetes therapies at baseline | 3 to 6 months |
| HbA1c change in patients prescribed semaglutide as fourth line therapy (excluding insulin use) | In the subgroup of patients using three oral diabetes therapies at baseline | 3 to 6 months |
| Weight change in patients prescribed semaglutide as fourth line therapy (excluding insulin use) | In the subgroup of patients using three oral diabetes therapies at baseline | 3 to 6 months |
| D004700 | Endocrine System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |