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

NCT06351748 | Completed

• 2 other identifiers: NN9535-7877U1111-1296-3151
• Study Type: observational
• Target: 34,238
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Change in Haemoglobin A1c (HbA1c) level

  Measured in Percentage (%).

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

• 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

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

  Measured in percentage of participants.

  At 6 months

Secondary Outcomes (9)

• Change in HbA1c level

  From baseline (3 months prior to or on the index date) to 12 months

• Change in HbA1c level

  From baseline (3 months prior to or on the index date) to 12 months

• Proportion of participants achieving HbA1c <7.0%

  At 12 months

• Change in body weight

  From baseline (3 months prior to or on the index date) to 12 months

• Change in body weight

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

Study Arms (1)

Participants with T2DM

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.

Drug: Semaglutide

Interventions

Semaglutide DRUG

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

Also known as: Ozempic

Participants with T2DM

Eligibility Criteria

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

Study Population

Participants diagnosed with T2DM who initiated semaglutide OW for the first time during the patient identification period.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Tianjin Medical University Chu Hsien-I Memorial Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

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: April 2, 2024
• First Posted: April 8, 2024
• Study Start: January 2, 2024
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)