Comprehensive Clinical Evaluation Study of GLP-1RA

NCT06686134 | Recruiting

• 1 other identifier: QFS-LY-2024-GLP-1RA-001
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this project is to identify the most efficacious glucagon-like peptide-1 receptor agonists (GLP-1RAs) for the treatment of adult patients with type 2 diabetes mellitus (T2DM). In accordance with the index system and evaluation rules set forth in the Management Guidelines for Comprehensive Clinical Evaluation of Drugs, the effects of GLP-1RAs drugs in real-world settings are tracked, summarised, and analysed across six dimensions: safety, effectiveness, economy, innovation, appropriateness, and accessibility. This is done with the objective of ensuring that these drugs are fully utilised in accordance with their potential benefits. The objective is to ascertain the role of medical institutions as the principal entity responsible for the comprehensive evaluation of the clinical application of drugs and to provide data that will reduce the risk of using GLP-1RAs drugs. Moreover, the objective is to ascertain the advantages of their clinical application and to guarantee the safe and rational use of drugs for patients with type 2 diabetes mellitus. The objective of this study is to facilitate the fulfilment of medical institutions' role as the primary entity responsible for the comprehensive evaluation of the clinical application of medicines. Furthermore, the study will provide data that can be used to reduce the risk of using GLP-1RAs drugs, explore the advantages of their clinical application, and guarantee the safe and rational use of medicines for patients with type 2 diabetes.

Conditions

T2DM

Keywords

GLP1-RA

Outcome Measures

Primary Outcomes (2)

• HbA1c compliance rate

  HbA1c\<7

  4, 8, 12, and 16 weeks after the start of medication

• Weight reduction from baseline

  4, 8, 12, and 16 weeks after the start of medication

Study Arms (4)

liraglutide

Dulagoside

Polyethylene glycol losenatide

Semaglutide

Eligibility Criteria

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

Study Population

type 2 diabetes

You may qualify if:

• Diagnosed with type 2 diabetes;
• no study drug has been used in the last three months;
• Existing hypoglycemic programs include investigational drugs;
• Age ≥18 years old;
• The patient's demographic data, disease history, course records, laboratory test indicators, drug use and other information were complete;
• Sign informed consent.

You may not qualify if:

• persistent influenza, autoimmune disease, or other metabolic disease;
• There are obvious gastrointestinal diseases, gastrointestinal resection or malabsorption syndrome;
• diet drugs, glucocorticoids, drugs affecting gastrointestinal motility are being used;
• Patients with severe liver and kidney function impairment and patients with malignant tumors;
• Pregnant or lactating women.

Sponsors & Collaborators

• LI YAN: lead

Study Sites (1)

Yan Li

Jinan, China

RECRUITING

Related Publications (1)

• Pratley RE, Aroda VR, Lingvay I, Ludemann J, Andreassen C, Navarria A, Viljoen A; SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018 Apr;6(4):275-286. doi: 10.1016/S2213-8587(18)30024-X. Epub 2018 Feb 1.

  PMID: 29397376 RESULT

Study Officials

• Yining Dong, pharmacist

  Shandong Third Hospital

  PRINCIPAL INVESTIGATOR

• Zhongming Wu, doctor

  Endocrine and Metabolic Disease Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

• Yue Liu, pharmacist

  Shandong University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Dandan Wu, pharmacist

  Affiliated Hospital of Binzhou Medical College

  PRINCIPAL INVESTIGATOR

• Jing Peng, pharmacist

  Jining Medical University

  PRINCIPAL INVESTIGATOR

• Qi Wang, pharmacist

  Jinan Fifth People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhaohui Meng, pharmacist

  Jinan Laiwu People's Hospital

  PRINCIPAL INVESTIGATOR

• Dong wei Wang, doctor

  Jinan Mental Health Center

  PRINCIPAL INVESTIGATOR

• Zhong Yuan, pharmacist

  Jinan Municipal Hospital

  PRINCIPAL INVESTIGATOR

• Ming Xue, pharmacist

  Jinan Hospital, Guang'anmen Hospital, China Academy of Traditional Chinese Medicine, China

  PRINCIPAL INVESTIGATOR

• Jing Lin, pharmacist

  Shijhong District People's Hospital

  PRINCIPAL INVESTIGATOR

• Xingshan Wang, doctor

  Changqing District Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Min Fan, pharmacist

  Pingyin County People's Hospital

  PRINCIPAL INVESTIGATOR

• Xue Zheng, pharmacist

  Zibo Center Hospital

  PRINCIPAL INVESTIGATOR

• Ming Xu, pharmacist

  Zibo First Hospital

  PRINCIPAL INVESTIGATOR

• Yan Song, pharmacist

  Zibo Municipal Hospital

  PRINCIPAL INVESTIGATOR

• Ruoxun Liu, pharmacist

  Zibo Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Qing Zhao, doctor

  Linzi District Maternal and Child Health Center

  PRINCIPAL INVESTIGATOR

• Zhenwei Chen, pharmacist

  Yiyuan County People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhiyan Li, pharmacist

  Zaozhuang Municipal Hospital

  PRINCIPAL INVESTIGATOR

• Shenling Cheng, pharmacist

  Tengzhou Central People's Hospital

  PRINCIPAL INVESTIGATOR

• Qixia Zhao, pharmacist

  Zaozhuang Shanting District People's Hospital

  PRINCIPAL INVESTIGATOR

• Jintang Ning, pharmacist

  Dongying People's Hospital

  PRINCIPAL INVESTIGATOR

• Juying Ding, pharmacist

  Shengli Oilfield Hospital

  PRINCIPAL INVESTIGATOR

• Jiaxi Jiang, pharmacist

  Haiyang People's Hospital

  PRINCIPAL INVESTIGATOR

• Guichun Wang, pharmacist

  Longko People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhentian Cheng, pharmacist

  Weifang Yidu Center Hospital

  PRINCIPAL INVESTIGATOR

• Yueliang Ji, doctor

  Fangzi District People's Hospital

  PRINCIPAL INVESTIGATOR

• Donglou Liang, pharmacist

  Jining First People's Hospital

  PRINCIPAL INVESTIGATOR

• Li Zhang, pharmacist

  QuFu People's Hospital

  PRINCIPAL INVESTIGATOR

• Guifeng Tan, doctor

  Wenshang County People's Hospital

  PRINCIPAL INVESTIGATOR

• Ronghua Wang, pharmacist

  Weihai Maternal and Child Health Center

  PRINCIPAL INVESTIGATOR

• Jianfang Liu, pharmacist

  Rizhao People's Hospital

  PRINCIPAL INVESTIGATOR

• Xiangju Tian, doctor

  Linyi Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Pengcheng Du, pharmacist

  Shandong University Qilu Hospital, Dezhou Hospital

  PRINCIPAL INVESTIGATOR

• Fujian Xu, pharmacist

  Heze Municipal Hospital

  PRINCIPAL INVESTIGATOR

• Deping Ho, pharmacist

  Heze Third People's Hospital

  PRINCIPAL INVESTIGATOR

• Jingyong Xue, pharmacist

  Heze Mudan People's Hospital

  PRINCIPAL INVESTIGATOR

• Lishun Yin, pharmacist

  Heze Dingtao District People's Hospital

  PRINCIPAL INVESTIGATOR

• Shengmei Wei, pharmacist

  Caoxian People's Hospital

  PRINCIPAL INVESTIGATOR

• Jing Meng, pharmacist

  Shanxian Central Hospital

  PRINCIPAL INVESTIGATOR

• Ye Fan, pharmacist

  Yuncheng County People's Hospital

  PRINCIPAL INVESTIGATOR

• Jingjing Zhang, pharmacist

  Qingdao Eighth People's Hospital

  PRINCIPAL INVESTIGATOR

• Wenqian Han, pharmacist

  Tai'an Central Hospital

  PRINCIPAL INVESTIGATOR

• Wenwen Lv, pharmacist

  Affiliated Hospital of Binzhou Medical College

  PRINCIPAL INVESTIGATOR

• Tao Geng, pharmacist

  The Second Affiliated Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

• Fang Liu, pharmacist

  Shengli Oilfield Hospital

  PRINCIPAL INVESTIGATOR

• Congrong Wang, pharmacist

  Shandong Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

• Ping Wang, pharmacist

  Tengzhou Central People's Hospital

  PRINCIPAL INVESTIGATOR

• Yuxia Gao, pharmacist

  Dongying Hospital Affiliated to Shandong University of Traditional Chinese Medicine (Dongying Hospital of Traditional Chinese Medicine)

  PRINCIPAL INVESTIGATOR

• Bo Liu, pharmacist

  Qingdao Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Zhonghua The First Affiliated Hospital of Shandong First Medical Univer, master

CONTACT

+8618253161252; dzh941213@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Pharmacist

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 13, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

CN (1)