Clinical trial NCT06351748: Real-world Study of CHina Ozempic cLinicAl pRactice in Patients With Type 2 Diabetes (SCHOLAR)
Official title: Real-world Study of CHina Ozempic cLinicAl pRactice in Patients With Type 2 Diabetes (SCHOLAR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 34238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants diagnosed with T2DM who initiated semaglutide OW for the first time during the patient identification period.

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.


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

Primary outcomes:
measure: Change in Haemoglobin A1c (HbA1c) level
timeFrame: From baseline (3 months prior to or on the index date) to 6 months
measure: Change in HbA1c level
timeFrame: From baseline (3 months prior to or on the index date) to 6 months
measure: Proportion of participants achieving HbA1c less than (<) 7.0%
timeFrame: At 6 months
Secondary outcomes:
measure: Change in HbA1c level
timeFrame: From baseline (3 months prior to or on the index date) to 12 months
measure: Change in HbA1c level
timeFrame: From baseline (3 months prior to or on the index date) to 12 months
measure: Proportion of participants achieving HbA1c <7.0%
timeFrame: At 12 months
measure: Change in body weight
timeFrame: From baseline (3 months prior to or on the index date) to 12 months
measure: Change in body weight
timeFrame: From baseline (3 months prior to or on the index date) to 6 months
measure: Description of participants with different demographic characteristics
timeFrame: At baseline (12 months prior to or on the index date)
measure: Description of participants with different clinical characteristics
timeFrame: At baseline (36 months prior to or on the index date)
measure: Proportion of participants with different antidiabetic medications
timeFrame: At baseline (3 months prior to or on the index date)
measure: Proportion of participants with different non-antidiabetic medications
timeFrame: At baseline (3 months prior to or on the index date)
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Chu Hsien-I Memorial Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: