Menu
Not yet recruiting NCT07424430

Real-world Canadian Retrospective Study Evaluating Longitudinal Semaglutide Use on Cardio-Kidney-Metabolic Outcomes

— Observational Diabetes (DM) Type 2 Diabetes Obesity (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Semaglutide (SEMA).
Who it may be relevant to
Registry conditions: Diabetes (DM), Type 2 Diabetes, Obesity (Disorder). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Real-world Canadian Retrospective Study Evaluating Longitudinal SEMAglutide Use on Cardio-Kidney-Metabolic Outcomes

Overview

The goal of this study is to better understand the real-world effectiveness of semaglutide use on cardio-kidney-metabolic outcomes among adults with T2D and adults with obesity (without diabetes mellitus). This is a retrospective longitudinal analysis using the LMC Diabetes Registry. The primary outcome of the study is to evaluate the change in HbA1c between baseline to 3 years of follow-up among adults with T2D who initiated semaglutide compared to adults with T2D who initiated other AHAs, including sulfonylurea, dipeptidyl peptidase-4 inhibitors, and sodium-glucose cotransporter-2 inhibitors.

Interventions

  • Drug Semaglutide (SEMA)
    participants who initiate semaglutide

Primary outcome measures

  • Change in HbA1c- 3 Years [Time frame: Baseline to 3 Years]
Secondary outcome measures (12)
  • Change in HbA1c- 1 Year [Time frame: Baseline to 1 year]
  • Change in HbA1c- 2 Years [Time frame: Baseline to 2 Years]
  • Proportion of individuals who achieve HbA1c ≤ 7.0% - 1 Year [Time frame: Baseline to 1 Year]
  • Proportion of individuals who achieve HbA1c ≤ 7.0%- 2 Years [Time frame: Baseline to 2 Years]
  • Proportion of individuals who achieve HbA1c ≤ 7.0% - 3 Years [Time frame: Baseline to 3 Years]
  • Change in body weight- 1 Year [Time frame: Baseline to 1 Year]
  • Change in body weight- 2 Years [Time frame: Baseline to 2 Years]
  • Change in body weight- 3 Years [Time frame: Baseline to 3 Years]
  • Percent body weight loss ≥ 5% - 1 Year [Time frame: Baseline to 1 Year]
  • Percent body weight loss ≥ 5% - 2 Years [Time frame: Baseline to 2 Years]
  • Percent body weight loss ≥ 5% - 3 Years [Time frame: Baseline to 3 Years]
  • Percent body weight loss ≥ 10% - 1 Year [Time frame: Baseline to 1 Year]

Eligibility criteria

Inclusion criteria

T2D Cohort:

  • A clinical diagnosis of T2D ≥ 1 year
  • HbA1c ≥ 6.5% (pre-index date)
  • Initiated semaglutide or other AHA(s) before January 1st, 2023\*
  • Seen by an LMC endocrinologist in the last 18 months as of the query date
  • ≥ one HbA1c value up to 6 months (+ 90 days) prior to index date
  • Informed data consent for their medical record data to be used for research purposes

Obesity Cohort:

  • 18 years or older
  • BMI ≥ 27 kg/m2
  • HbA1c < 6.5% (pre-index date)
  • Initiated semaglutide before January 1st, 2023\*
  • Seen by an LMC endocrinologist in the last 18 months as of the query date
  • ≥ one HbA1c value up to 6 months (± 90 days) prior to index date
  • Informed data consent for their medical record data to be used for research purposes

Exclusion criteria

  • Clinical diagnosis of type 1 diabetes/latent autoimmune diabetes in adults (LADA)
  • Clinical diagnosis of T2D (obesity cohort only)
  • Are pregnant at the time of semaglutide or other AHA initiation or became pregnant during follow-up period
  • Documented history or family history of medullary thyroid carcinoma
  • Participation in a research study with an Investigational Product
  • eGFR < 15 mL/min/1.73m2 at index date
  • Use of non-semaglutide GLP-1-based medication for more than 6 months after the index date (T2D sema cohort and obesity sema cohort)
  • Use of other AHA for more than 6 months after the index date within the first year of semaglutide use (T2D sema cohort and obesity sema cohort)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07424430 · SEMA-CKM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗