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

Diabetes Mellitus, Type 2 Clinical Trial

— SCHOLAR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06351748
• Other study ID #: NN9535-7877
• Secondary ID: U1111-1296-3151
• Status: Enrolling by invitation
• Start date: April 5, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 27000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Medical University Chu Hsien-I Memorial Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Haemoglobin A1c (HbA1c) level	Measured in Percentage (%).	From baseline (3 months prior to or on the index date) to 6 months
Primary	Change in HbA1c level	Measured in millimoles per mol (mmol/mol)	From baseline (3 months prior to or on the index date) to 6 months
Primary	Proportion of participants achieving HbA1c less than (<) 7.0%	Measured in percentage of participants.	At 6 months
Secondary	Change in HbA1c level	Measured in %.	From baseline (3 months prior to or on the index date) to 12 months
Secondary	Change in HbA1c level	Measured in mmol/mol.	From baseline (3 months prior to or on the index date) to 12 months
Secondary	Proportion of participants achieving HbA1c <7.0%	Measured in percentage of participants.	At 12 months
Secondary	Change in body weight	Measured in kilograms.	From baseline (3 months prior to or on the index date) to 12 months
Secondary	Change in body weight	Measured in kilograms.	From baseline (3 months prior to or on the index date) to 6 months
Secondary	Description of participants with different demographic characteristics		At baseline (12 months prior to or on the index date)
Secondary	Description of participants with different clinical characteristics		At baseline (36 months prior to or on the index date)
Secondary	Proportion of participants with different antidiabetic medications	Measured in percentage of participants.	At baseline (3 months prior to or on the index date)
Secondary	Proportion of participants with different non-antidiabetic medications	Measured in percentage of participants.	At baseline (3 months prior to or on the index date)