Real-world Health Outcomes in Canadian Patients Using Semaglutide

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

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Observational
• Enrollment (Actual): 1133

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 3E8
      • LMC Diabetes & Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: LMC Diabetes & Endocrinology Ltd.
• Investigators: Principal Investigator: Ronnie Aronson, MD, LMC Diabetes & Endocrinology

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): February 9, 2020
• Study Completion (Actual): February 9, 2020

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: semaglutide; body weight; hemoglobin A1c; retrospective study
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SPARE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No