Clinical trial

Real-world Study of CHina Ozempic cLinicAl pRactice in Patients With Type 2 Diabetes (SCHOLAR)

Aliases

NCT06351748, NN9535-7877

Name

NN9535-7877

Description

This study is to describe the real-world use and impact of semaglutide once-weekly (OW) among participants with type 2 diabetes mellitus (T2DM) in China. Participants diagnosed with T2DM who initiated semaglutide OW for the first time between 1 Jan 2022 (the date when semaglutide OW was listed in the National Reimbursement Drug List \[NRDL\] in China\] and 28 Feb 2023 (9 months prior to the data extraction cut-off date of 30 Nov 2023) will be included in this study. The study period will be 36 months prior to the first date of participants identification period.

Trial arms

Trial start

2024-01-02

Estimated PCD

2024-03-29

Trial end

2024-03-29

Status

Completed

Treatment

Semaglutide

Participants received semaglutide OW according to local label and to routine clinical practice at the discretion of the treating physician.

Arms:

Participants with T2DM

Other names:

Ozempic

Size

34238

Primary endpoint

Change in Haemoglobin A1c (HbA1c) level

From baseline (3 months prior to or on the index date) to 6 months

Change in HbA1c level

From baseline (3 months prior to or on the index date) to 6 months

Proportion of participants achieving HbA1c less than (<) 7.0%

At 6 months

Eligibility criteria

Inclusion Criteria: * Male or female participants aged greater than or equal to (≥) 18 years on index date * Participants with diagnosis of T2DM prior to or on index date * Participants with initiation of semaglutide OW for the first time within the identification period Exclusion Criteria: * Participants with diagnosis of type 1 diabetes prior to or on index date * Participants who were pregnant within 36 months prior to or on index date * Participants who participated in any clinical trials within 36 months prior to or on index date which could be identified from medical records

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 34238, 'type': 'ACTUAL'}}

Updated at

2024-08-14

1 organization

Organization

Novo Nordisk