Real-world Health Outcomes in Canadian Patients Using Semaglutide

NCT04175665 | Completed

• 1 other identifier: SPARE
• Study Type: observational
• Target: 1,133
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

semaglutide; retrospective study; hemoglobin A1c; body weight

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c (%) between baseline and last measured value at 3 to 6 months follow-up

  3 to 6 months

Secondary Outcomes (17)

• Change in body weight

  3 to 6 months

• Change in body mass index (BMI)

  3 to 6 months

• Change in systolic blood pressure (SBP)

  3 to 6 months

• Change in diastolic blood pressure (DBP)

  3 to 6 months

• Change in triglycerides

  3 to 6 months

Other Outcomes (19)

• Time to addition of another diabetes therapy

  3 to 6 months

• Time to discontinuation of GLP-1 RA therapy

  3 to 6 months

• Insulin dose at baseline and follow-up

  3 to 6 months

Interventions

Semaglutide DRUG

Prescription for semaglutide as part of usual clinical practice

Also known as: Ozempic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Clinical diagnosis of type 1 diabetes
• Recent eGFR \<40 ml/min/1.73m2
• Documented history of bariatric surgery

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead

Study Sites (1)

LMC Diabetes & Endocrinology

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Body Weight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronnie Aronson, MD

  LMC Diabetes & Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: January 6, 2020
• Primary Completion: February 9, 2020
• Study Completion: February 9, 2020
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)