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Enrolling by invitation NCT07456774

A Two-armed Real-world Study of Ozempic (OW Semaglutide) to Evaluate Its Adherence and Persistence Compared With Other Anti-diabetic Drugs Among Adult T2DM Patients in China

— Observational Type 2 Diabetes

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. 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
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Retrospective Database Study to Compare Cardiovascular and Renal Outcomes of Ozempic® (OW Semaglutide) Versus Other Anti-Diabetic Drugs in Chinese T2D Patients

Overview

The study is testing the incidence of MACE and incidence of renal events between Ozempic® users and users with other anti-diabetic medications in T2D patients. This is a retrospective study, and participants had received Ozempic or any other anti-diabetic medications.

Primary outcome measures

  • Time to 3P major adverse cardiovascular events [Time frame: From index date to the first composite 3P MACE (stroke, myocardial infarction, all-cause death) event or censoring event (up to 36 months)]
  • Time to 5P MACE [Time frame: From index date to the first composite 5P MACE (stroke, myocardial infarction, all-cause death, heart failure hospitalization, coronary revascularization) event or censoring event (up to 36 months)]
  • Time to stroke [Time frame: From index date to the first stroke event or censoring event (up to 36 months)]
  • Time to myocardial infarction (MI) [Time frame: From index date to the first MI event or censoring event (up to 36 months)]
  • Time to heart failure (HF) [Time frame: From index date to the first HF event or censoring event (up to 36 months)]
  • Time to composite renal event [Time frame: From index date to first composite renal (kidney failure: dialysis/transplantation/eGFR <15, ≥50% eGFR reduction from baseline, or kidney-related/cardiovascular death) or censoring event (up to 36 months)]
  • Time to renal disease-related hospitalization [Time frame: From index date to the first renal disease-related hospitalization or censoring event (up to 36 months)]
  • Incidence rate of 3P MACE [Time frame: From index date to the first composite 3P MACE (stroke, myocardial infarction, all-cause death) event or censoring event (up to 36 months)]
  • Incidence rate of 5P MACE [Time frame: From index date to the first composite 5P MACE (stroke, myocardial infarction, all-cause death, heart failure hospitalization, coronary revascularization) event or censoring event (up to 36 months)]
  • Incidence rate of stroke [Time frame: From index date to the first stroke event or censoring event (up to 36 months)]
Secondary outcome measures (2)
  • Proportion of days covered (PDC) in 6 months [Time frame: From index date to Day 180]
  • PDC in 12 months [Time frame: From index date to Day 360]

Eligibility criteria

Inclusion criteria

  • Participants had at least one prescription for Ozempic® or other interested anti-diabetic medications during the index identification period.
  • Participants had at least one diagnosis of T2D, and had at least one of the three following T2D clinical evidence any time before or on the index date
  • Participants had at least 1 all-cause visit record any time after 6 months post-index date.
  • At least 18 years old at the index date.

Exclusion criteria

  • Patients who have used any same anti-diabetic medications as the index treatment within 6 months before index date (e.g., patient prescribed with any Ozempic® during baseline will be excluded if the index drug is a Ozempic®)
  • Patients with any diagnosis record of type 1 diabetes or gestational diabetes during whole study period.
  • Patients who were pregnant during the whole study period.
  • Patients who participated in any clinical trials during the whole study period.
  • Patients who were diagnosed with medullary thyroid carcinoma or multiple endocrine neoplasia type II (MEN2) during the whole study period.

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

China · 1 center
  • NIS- Tianjin Medical University Chu Hsien-I Memorial Hospital-Department of Endocrinology — Tianjin

Identifiers

NCT: NCT07456774 · NN9535-8602

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗