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Completed

NCT Number: NCT06351748

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University Chu Hsien-I Memorial Hospital

Tianjin, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

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

Other names: Ozempic

Primary outcomes

  1. Change in Haemoglobin A1c (HbA1c) level

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

    Measured in Percentage (%).

  2. Change in HbA1c level

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

    Measured in millimoles per mol (mmol/mol)

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

    Time frame: At 6 months

    Measured in percentage of participants.

Secondary outcomes

  1. Change in HbA1c level

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

    Measured in %.

  2. Change in HbA1c level

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

    Measured in mmol/mol.

  3. Proportion of participants achieving HbA1c <7.0%

    Time frame: At 12 months

    Measured in percentage of participants.

  4. Change in body weight

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

    Measured in kilograms.

  5. Change in body weight

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

    Measured in kilograms.

  6. Description of participants with different demographic characteristics

    Time frame: At baseline (12 months prior to or on the index date)

  7. Description of participants with different clinical characteristics

    Time frame: At baseline (36 months prior to or on the index date)

  8. Proportion of participants with different antidiabetic medications

    Time frame: At baseline (3 months prior to or on the index date)

    Measured in percentage of participants.

  9. Proportion of participants with different non-antidiabetic medications

    Time frame: At baseline (3 months prior to or on the index date)

    Measured in percentage of participants.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: SCHOLAR

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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