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Type 2 DiabetesNCT04175665

Real-world Health Outcomes in Canadian Patients Using Semaglutide

An observational study of Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Semaglutide
How many people
1,133 participants
Where
1 siteCanada
Study dates
6 Jan 2020to 9 Feb 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • LMC Diabetes & Endocrinology

    Toronto, Ontario, M4G 3E8

Other trials in Canada

About this study

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

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
Being tested
Semaglutide
Keywords
semaglutide, retrospective study, hemoglobin A1c, body weight
Medical subject headings
Diabetes Mellitus, Type 2, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Also called Ozempic

    Prescription for semaglutide as part of usual clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c

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

    Measured: 3 to 6 months

Secondary outcomes (17)

  1. Change in body weight

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

    Measured: 3 to 6 months

  2. Change in body mass index (BMI)

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

    Measured: 3 to 6 months

  3. Change in systolic blood pressure (SBP)

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

    Measured: 3 to 6 months

  4. Change in diastolic blood pressure (DBP)

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

    Measured: 3 to 6 months

  5. Change in triglycerides

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

    Measured: 3 to 6 months

  6. Change in LDL cholesterol

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

    Measured: 3 to 6 months

  7. 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

    Measured: 3 to 6 months

  8. 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

    Measured: 3 to 6 months

  9. Change in alanine amino transaminase (ALT)

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

    Measured: 3 to 6 months

  10. 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

    Measured: 3 to 6 months

  11. 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

    Measured: 3 to 6 months

  12. Proportion of patients who achieve HbA1c ≤7.0%

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

    Measured: 3 to 6 months

  13. Proportion of patients who achieve HbA1c ≤8.0%

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

    Measured: 3 to 6 months

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

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

    Measured: 3 to 6 months

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

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

    Measured: 3 to 6 months

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

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

    Measured: 3 to 6 months

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

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

    Measured: 3 to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2019
  2. Study start6 Jan 2020
  3. Primary completion9 Feb 2020
  4. Study completion9 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04175665
Sponsor's protocol ID
SPARE
Status last verified
Feb 2020
First submitted
21 Nov 2019
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (time frame: 3 to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04175665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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