Clinical trial NCT04175665: Real-world Health Outcomes in Canadian Patients Using Semaglutide
Official title: Semaglutide in Patients With Type 2 Diabetes: Real-world Analysis in the Canadian LMC Diabetes Registry: The SPARE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: semaglutide
retrospective study
hemoglobin A1c
body weight
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 1133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: 3 to 6 months
Secondary outcomes:
measure: Change in body weight
timeFrame: 3 to 6 months
measure: Change in body mass index (BMI)
timeFrame: 3 to 6 months
measure: Change in systolic blood pressure (SBP)
timeFrame: 3 to 6 months
measure: Change in diastolic blood pressure (DBP)
timeFrame: 3 to 6 months
measure: Change in triglycerides
timeFrame: 3 to 6 months
measure: Change in LDL cholesterol
timeFrame: 3 to 6 months
measure: Change in non-HDL cholesterol
timeFrame: 3 to 6 months
measure: Change in estimated glomerular filtration rate (eGFR)
timeFrame: 3 to 6 months
measure: Change in alanine amino transaminase (ALT)
timeFrame: 3 to 6 months
measure: Proportion of patients who report ≥ 1 weekly incidence of any hypoglycemia
timeFrame: 3 to 6 months
measure: Proportion of patients who report ≥ 1 yearly incidence of severe hypoglycemia
timeFrame: 3 to 6 months
measure: Proportion of patients who achieve HbA1c ≤7.0%
timeFrame: 3 to 6 months
measure: Proportion of patients who achieve HbA1c ≤8.0%
timeFrame: 3 to 6 months
measure: Proportion of patients who achieve HbA1c reduction ≥0.5%
timeFrame: 3 to 6 months
measure: Proportion of patients who achieve HbA1c reduction ≥1.0%
timeFrame: 3 to 6 months
measure: Proportion of patients who achieve weight loss ≥5%
timeFrame: 3 to 6 months
measure: Proportion of patients who achieve weight loss ≥10%
timeFrame: 3 to 6 months
Other outcomes:
measure: Time to addition of another diabetes therapy
timeFrame: 3 to 6 months
measure: Time to discontinuation of GLP-1 RA therapy
timeFrame: 3 to 6 months
measure: Insulin dose at baseline and follow-up
timeFrame: 3 to 6 months
measure: HbA1c change in low dose therapy and high dose therapy subgroups
timeFrame: 3 to 6 months
measure: Body weight change in low dose therapy and high dose therapy subgroups
timeFrame: 3 to 6 months
measure: HbA1c change in patients who discontinue a dipeptidyl peptidase-4 inhibitor (DPP-4i) at baseline versus simple addition of semaglutide
timeFrame: 3 to 6 months
measure: Body weight change in patients who discontinue a DPP-4i at baseline versus simple addition of semaglutide
timeFrame: 3 to 6 months
measure: HbA1c change in patients who discontinue any diabetes therapy at baseline versus simple addition of semaglutide
timeFrame: 3 to 6 months
measure: Body weight change in patients who discontinue any diabetes therapy at baseline versus simple addition of semaglutide
timeFrame: 3 to 6 months
measure: HbA1c change in insulin users and non-insulin users
timeFrame: 3 to 6 months
measure: Weight change in insulin users and non-insulin users
timeFrame: 3 to 6 months
measure: HbA1c change in patients who have a 13-week follow-up versus a 26-week follow-up
timeFrame: 3 to 6 months
measure: Weight change in patients who have a 13-week follow-up versus a 26-week follow-up
timeFrame: 3 to 6 months
measure: HbA1c change in patients prescribed semaglutide as second line therapy (excluding insulin use)
timeFrame: 3 to 6 months
measure: Weight change in patients prescribed semaglutide as second line therapy (excluding insulin use)
timeFrame: 3 to 6 months
measure: HbA1c change in patients prescribed semaglutide as third line therapy (excluding insulin use)
timeFrame: 3 to 6 months
measure: Weight change in patients prescribed semaglutide as third line therapy (excluding insulin use)
timeFrame: 3 to 6 months
measure: HbA1c change in patients prescribed semaglutide as fourth line therapy (excluding insulin use)
timeFrame: 3 to 6 months
measure: Weight change in patients prescribed semaglutide as fourth line therapy (excluding insulin use)
timeFrame: 3 to 6 months
Locations:
city: Toronto
country: Canada
facility: LMC Diabetes & Endocrinology
state: Ontario
Study officials:
affiliation: LMC Diabetes & Endocrinology
name: Ronnie Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References: