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

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Semaglutide

• Registration Number: NCT06351748
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-02
• Primary Completion: 2024-03-29
• Study Completion: 2024-03-29
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34238

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with T2DM	Semaglutide	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.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c level	From baseline (3 months prior to or on the index date) to 6 months	Measured in millimoles per mol (mmol/mol)
Change in Haemoglobin A1c (HbA1c) level	From baseline (3 months prior to or on the index date) to 6 months	Measured in Percentage (%).
Proportion of participants achieving HbA1c less than (<) 7.0%	At 6 months	Measured in percentage of participants.

Secondary Outcome Measures

Name	Time	Method
Description of participants with different clinical characteristics	At baseline (36 months prior to or on the index date)
Change in HbA1c level	From baseline (3 months prior to or on the index date) to 12 months	Measured in mmol/mol.
Proportion of participants achieving HbA1c <7.0%	At 12 months	Measured in percentage of participants.
Change in body weight	From baseline (3 months prior to or on the index date) to 6 months	Measured in kilograms.
Proportion of participants with different antidiabetic medications	At baseline (3 months prior to or on the index date)	Measured in percentage of participants.
Proportion of participants with different non-antidiabetic medications	At baseline (3 months prior to or on the index date)	Measured in percentage of participants.
Description of participants with different demographic characteristics	At baseline (12 months prior to or on the index date)

Trial Locations

Locations (1)

Tianjin Medical University Chu Hsien-I Memorial Hospital; 🇨🇳 Tianjin, China