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

NCT07456774 | Enrolling By Invitation

• 1 other identifier: NN9535-8602
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (14)

• Time to 3P major adverse cardiovascular events

  Measured in days.

  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

  Measured in days.

  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

  Measured in days.

  From index date to the first stroke event or censoring event (up to 36 months)

• Time to myocardial infarction (MI)

  Measured in days.

  From index date to the first MI event or censoring event (up to 36 months)

• Time to heart failure (HF)

  Measured in days.

  From index date to the first HF event or censoring event (up to 36 months)

• Time to composite renal event

  Measured in days.

  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

  Measured in days.

  From index date to the first renal disease-related hospitalization or censoring event (up to 36 months)

• Incidence rate of 3P MACE

  Measured in Percentage, per 1000 patient year.

  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

  Measured in Percentage, per 1000 patient year.

  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

  Measured in Percentage, per 1000 patient year.

  From index date to the first stroke event or censoring event (up to 36 months)

• Incidence rate of myocardial infarction

  Measured in Percentage, per 1000 patient year.

  From index date to the first MI event or censoring event (up to 36 months)

• Incidence rate of heart failure

  Measured in Percentage, per 1000 patient year.

  From index date to the first HF event or censoring event (up to 36 months)

• Incidence rate of composite renal event

  Measured in Percentage, per 1000 patient year.

  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)

• Incidence rate of renal disease-related hospitalization

  Measured in Percentage, per 1000 patient year.

  From index date to the first renal disease-related hospitalization or censoring event (up to 36 months)

Secondary Outcomes (2)

• Proportion of days covered (PDC) in 6 months

  From index date to Day 180

• PDC in 12 months

  From index date to Day 360

Study Arms (2)

Ozempic users

This cohort includes the participants who received Ozempic (semaglutide) as prescribed.

Non-Ozempic users

This cohort includes the participants who received other anti-diabetic medication(s) as prescribed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants received Ozempic (semaglutide) and any other prescribed anti-diabetic medication(s).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

NIS- Tianjin Medical University Chu Hsien-I Memorial Hospital-Department of Endocrinology

Tianjin, Tianjin Municipality, 300074, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: March 6, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)