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OpenTrials
Completed

NCT Number: NCT04175665

Real-world Health Outcomes in Canadian Patients Using Semaglutide

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LMC Diabetes & Endocrinology

Toronto, Ontario, M4G 3E8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

Prescription for semaglutide as part of usual clinical practice

Other names: Ozempic

Primary outcomes

  1. Change in HbA1c

    Time frame: 3 to 6 months

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

Secondary outcomes

  1. Change in body weight

    Time frame: 3 to 6 months

    Change in body weight (kg) between baseline and last measured value at 3 to 6 months follow-up

  2. Change in body mass index (BMI)

    Time frame: 3 to 6 months

    Change in BMI (kg/m2) between baseline and last measured value at 3 to 6 months follow-up

  3. Change in systolic blood pressure (SBP)

    Time frame: 3 to 6 months

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

  4. Change in diastolic blood pressure (DBP)

    Time frame: 3 to 6 months

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

  5. Change in triglycerides

    Time frame: 3 to 6 months

    Change in triglycerides (mmol/L) between baseline and last measured value at 3 to 6 months follow-up

  6. Change in LDL cholesterol

    Time frame: 3 to 6 months

    Change in LDL cholesterol (mmol/L) between baseline and last measured value at 3 to 6 months follow-up

  7. Change in non-HDL cholesterol

    Time frame: 3 to 6 months

    Change in non-HDL cholesterol (mmol/L) between baseline and last measured value at 3 to 6 months follow-up

  8. Change in estimated glomerular filtration rate (eGFR)

    Time frame: 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

  9. Change in alanine amino transaminase (ALT)

    Time frame: 3 to 6 months

    Change in ALT (U/L) between baseline and last measured value at 3 to 6 months follow-up

  10. Proportion of patients who report ≥ 1 weekly incidence of any hypoglycemia

    Time frame: 3 to 6 months

    Analyses will also be stratified by sulfonylurea (SU) versus non-SU use, and insulin versus non-insulin use

  11. Proportion of patients who report ≥ 1 yearly incidence of severe hypoglycemia

    Time frame: 3 to 6 months

    Analyses will also be stratified by SU versus non-SU use, and insulin versus non-insulin use

  12. Proportion of patients who achieve HbA1c ≤7.0%

    Time frame: 3 to 6 months

    HbA1c will be the last measured value at 3 to 6 months follow-up

  13. Proportion of patients who achieve HbA1c ≤8.0%

    Time frame: 3 to 6 months

    HbA1c will be the last measured value at 3 to 6 months follow-up

  14. Proportion of patients who achieve HbA1c reduction ≥0.5%

    Time frame: 3 to 6 months

    HbA1c will be the last measured value at 3 to 6 months follow-up

  15. Proportion of patients who achieve HbA1c reduction ≥1.0%

    Time frame: 3 to 6 months

    HbA1c will be the last measured value at 3 to 6 months follow-up

  16. Proportion of patients who achieve weight loss ≥5%

    Time frame: 3 to 6 months

    Weight will be the last measured value at 3 to 6 months follow-up

  17. Proportion of patients who achieve weight loss ≥10%

    Time frame: 3 to 6 months

    Weight will be the last measured value at 3 to 6 months follow-up

Other outcomes

  1. Time to addition of another diabetes therapy

    Time frame: 3 to 6 months

    Number of weeks until addition of another diabetes therapy

  2. Time to discontinuation of GLP-1 RA therapy

    Time frame: 3 to 6 months

    Number of weeks until discontinuation of semaglutide therapy in patients who discontinue semaglutide during the follow-up period

  3. Insulin dose at baseline and follow-up

    Time frame: 3 to 6 months

    Insulin dose will be evaluated in the subgroup of patients using insulin therapy

  4. HbA1c change in low dose therapy and high dose therapy subgroups

    Time frame: 3 to 6 months

    Low dose therapy (semaglutide 0.5 mg) and full dose therapy (semaglutide 1.0 mg)

  5. Body weight change in low dose therapy and high dose therapy subgroups

    Time frame: 3 to 6 months

    Low dose therapy (semaglutide 0.5 mg) and full dose therapy (semaglutide 1.0 mg)

  6. HbA1c change in patients who discontinue a dipeptidyl peptidase-4 inhibitor (DPP-4i) at baseline versus simple addition of semaglutide

    Time frame: 3 to 6 months

  7. Body weight change in patients who discontinue a DPP-4i at baseline versus simple addition of semaglutide

    Time frame: 3 to 6 months

  8. HbA1c change in patients who discontinue any diabetes therapy at baseline versus simple addition of semaglutide

    Time frame: 3 to 6 months

  9. Body weight change in patients who discontinue any diabetes therapy at baseline versus simple addition of semaglutide

    Time frame: 3 to 6 months

  10. HbA1c change in insulin users and non-insulin users

    Time frame: 3 to 6 months

    Based on insulin therapy used at baseline

  11. Weight change in insulin users and non-insulin users

    Time frame: 3 to 6 months

    Based on insulin therapy used at baseline

  12. HbA1c change in patients who have a 13-week follow-up versus a 26-week follow-up

    Time frame: 3 to 6 months

  13. Weight change in patients who have a 13-week follow-up versus a 26-week follow-up

    Time frame: 3 to 6 months

  14. HbA1c change in patients prescribed semaglutide as second line therapy (excluding insulin use)

    Time frame: 3 to 6 months

    In the subgroup of patients using one oral diabetes therapy at baseline

  15. Weight change in patients prescribed semaglutide as second line therapy (excluding insulin use)

    Time frame: 3 to 6 months

    In the subgroup of patients using one other diabetes therapy at baseline

  16. HbA1c change in patients prescribed semaglutide as third line therapy (excluding insulin use)

    Time frame: 3 to 6 months

    In the subgroup of patients using two oral diabetes therapies at baseline

  17. Weight change in patients prescribed semaglutide as third line therapy (excluding insulin use)

    Time frame: 3 to 6 months

    In the subgroup of patients using two oral diabetes therapies at baseline

  18. HbA1c change in patients prescribed semaglutide as fourth line therapy (excluding insulin use)

    Time frame: 3 to 6 months

    In the subgroup of patients using three oral diabetes therapies at baseline

  19. Weight change in patients prescribed semaglutide as fourth line therapy (excluding insulin use)

    Time frame: 3 to 6 months

    In the subgroup of patients using three oral diabetes therapies at baseline

Sponsors and collaborators

Lead sponsor

LMC Diabetes & Endocrinology Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2019
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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