Real-world Health Outcomes in Canadian Patients Using Semaglutide
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT04175665
- Lead Sponsor
- LMC Diabetes & Endocrinology Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1133
- 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
- Clinical diagnosis of type 1 diabetes
- Recent eGFR <40 ml/min/1.73m2
- Documented history of bariatric surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1c 3 to 6 months Change in HbA1c (%) between baseline and last measured value at 3 to 6 months follow-up
- Secondary Outcome Measures
Name Time Method Proportion of patients who achieve HbA1c ≤8.0% 3 to 6 months HbA1c will be the last measured value at 3 to 6 months follow-up
Proportion of patients who achieve HbA1c reduction ≥0.5% 3 to 6 months HbA1c will be the last measured value at 3 to 6 months follow-up
Proportion of patients who achieve HbA1c reduction ≥1.0% 3 to 6 months HbA1c will be the last measured value at 3 to 6 months follow-up
Proportion of patients who achieve weight loss ≥10% 3 to 6 months Weight will be the last measured value at 3 to 6 months follow-up
Change in body weight 3 to 6 months Change in body weight (kg) between baseline and last measured value at 3 to 6 months follow-up
Change in diastolic blood pressure (DBP) 3 to 6 months Change in DBP (mmHg) between baseline and last measured value at 3 to 6 months follow-up
Change in non-HDL cholesterol 3 to 6 months Change in non-HDL cholesterol (mmol/L) between baseline and last measured value at 3 to 6 months follow-up
Change in estimated glomerular filtration rate (eGFR) 3 to 6 months Change in eGFR (mL/min/1.73 m2) between baseline and last measured value at 3 to 6 months follow-up
Change in body mass index (BMI) 3 to 6 months Change in BMI (kg/m2) between baseline and last measured value at 3 to 6 months follow-up
Proportion of patients who report ≥ 1 yearly incidence of severe hypoglycemia 3 to 6 months Analyses will also be stratified by SU versus non-SU use, and insulin versus non-insulin use
Proportion of patients who achieve weight loss ≥5% 3 to 6 months Weight will be the last measured value at 3 to 6 months follow-up
Change in systolic blood pressure (SBP) 3 to 6 months Change in SBP (mmHg) between baseline and last measured value at 3 to 6 months follow-up
Change in LDL cholesterol 3 to 6 months Change in LDL cholesterol (mmol/L) between baseline and last measured value at 3 to 6 months follow-up
Change in alanine amino transaminase (ALT) 3 to 6 months Change in ALT (U/L) between baseline and last measured value at 3 to 6 months follow-up
Proportion of patients who report ≥ 1 weekly incidence of any hypoglycemia 3 to 6 months Analyses will also be stratified by sulfonylurea (SU) versus non-SU use, and insulin versus non-insulin use
Proportion of patients who achieve HbA1c ≤7.0% 3 to 6 months HbA1c will be the last measured value at 3 to 6 months follow-up
Change in triglycerides 3 to 6 months Change in triglycerides (mmol/L) between baseline and last measured value at 3 to 6 months follow-up
Trial Locations
- Locations (1)
LMC Diabetes & Endocrinology
🇨🇦Toronto, Ontario, Canada