Real-world Health Outcomes in Canadian Patients Using Semaglutide

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175665
• Other study ID #: SPARE
• Status: Completed
• Start date: January 6, 2020
• Est. completion date: February 9, 2020

Study information

• Verified date: February 2020
• Source: LMC Diabetes & Endocrinology Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1133
• Est. completion date: February 9, 2020
• Est. primary completion date: February 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Semaglutide
Prescription for semaglutide as part of usual clinical practice

Locations

Country	Name	City	State
Canada	LMC Diabetes & Endocrinology	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
LMC Diabetes & Endocrinology Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to addition of another diabetes therapy	Number of weeks until addition of another diabetes therapy	3 to 6 months
Other	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
Other	Insulin dose at baseline and follow-up	Insulin dose will be evaluated in the subgroup of patients using insulin therapy	3 to 6 months
Other	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
Other	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
Other	HbA1c change in patients who discontinue a dipeptidyl peptidase-4 inhibitor (DPP-4i) at baseline versus simple addition of semaglutide		3 to 6 months
Other	Body weight change in patients who discontinue a DPP-4i at baseline versus simple addition of semaglutide		3 to 6 months
Other	HbA1c change in patients who discontinue any diabetes therapy at baseline versus simple addition of semaglutide		3 to 6 months
Other	Body weight change in patients who discontinue any diabetes therapy at baseline versus simple addition of semaglutide		3 to 6 months
Other	HbA1c change in insulin users and non-insulin users	Based on insulin therapy used at baseline	3 to 6 months
Other	Weight change in insulin users and non-insulin users	Based on insulin therapy used at baseline	3 to 6 months
Other	HbA1c change in patients who have a 13-week follow-up versus a 26-week follow-up		3 to 6 months
Other	Weight change in patients who have a 13-week follow-up versus a 26-week follow-up		3 to 6 months
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Change in HbA1c	Change in HbA1c (%) between baseline and last measured value at 3 to 6 months follow-up	3 to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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