Comprehensive Clinical Evaluation Study of GLP-1RA

NCT ID: NCT06686134

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 492 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-07-31

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.

Detailed Description

This study employed a prospective cohort design and included patients with type 2 diabetes mellitus (T2DM) who were receiving treatment with liraglutide, dulaglutide, polyethylene glycol losenatide, or simethicone. The subjects' basic information was collected, including their hospitalisation number, name, gender, age, date of birth, ethnicity, and occupation. Furthermore, data pertaining to the subjects' lifestyle habits were collected, including their history of smoking and alcohol consumption. Information pertaining to the circumstances of their hospitalisation was also collated, including the time, number, route, department, and diagnosis. Furthermore, data regarding the subjects' diabetic complications and past medical history were collected. Lastly, the time of discharge and diagnosis were recorded.

1. Collection of information on hospitalization:

• General information: basic information (hospitalization number, name, gender, age, date of birth, ethnicity, occupation), lifestyle information (history of smoking, history of alcohol consumption), admission (admission time, number, route, department, diagnosis), information on diabetic complications and past medical history, and discharge (discharge time and diagnosis).

② The data presented herewith pertain to the admission test. The data set includes basic information such as height, weight, body mass index (BMI), blood pressure, and temperature. Additionally, it encompasses glucose metabolism indicators, including fasting glucose, 2-hour postprandial glucose, and glycated hemoglobin. It also includes lipid metabolism indicators, such as triglycerides and total cholesterol. Furthermore, the examination of high-density and low-density lipoproteins, electrolytes (potassium, sodium, magnesium, calcium ion concentration), and indicators of hepatic and renal function (glutamic acid aminotransferase, glutamic oxaloquatamidase) is essential. Furthermore, the following biochemical parameters were analysed: total bile acid, total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, urea, creatinine. Additionally, routine blood indicators were evaluated, including haemoglobin, blood ketone bodies, white blood cell count, red blood cell count, and platelet count. Additionally, indicators of thyroid function are included, comprising free triiodothyronine, free thyroxine, thyrotropin, thyroid peroxidase antibodies, and thyroglobulin antibodies. Routine urine indicators are also provided, including pH, urine sugar, and urine ketone bodies.

(iii) Information on medication used during hospitalization: name of GLP-1AR drugs used, medication status (dosage, frequency, route, time and duration of administration), name of drugs used in combination, dosage, route of administration, course of treatment, and so on.

④Discharge examination data: basic information (weight, blood pressure, body temperature), glucose metabolism indicators (fasting blood glucose, postprandial 2h blood glucose, glycated hemoglobin), lipid metabolism indicators (triglycerides, total cholesterol, high-density lipoproteins, low-density lipoproteins), electrolyte indicators (potassium, sodium, magnesium, calcium ion concentration), indicators of hepatic and renal function (glutamic oxaloacetic aminase, glutamic oxaloacetic aminotransferase, total bile acid, total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, urea, creatinine), routine blood indicators (hemoglobin, blood ketones, white blood cell count, red blood cell count, platelet count), and routine urinary indicators (pH, urinary glucose, urinary ketones).

(2) Collection of follow-up information

• Follow-up period and duration: follow-up of the included patients at the end of the 4th, 8th, 12th, and 16th weekends of drug administration, for a total of 12 weeks.

• Format: telephone follow-up.

③ Follow-up information collection: Patient medication adherence: Morisky scale; Efficacy/safety: basic information, glucose metabolism indexes, lipid metabolism indexes, adverse drug reactions and other data from the beginning of drug administration to the end of the 4th, 8th, 12th and 16th weekends.

(3) Recording and assessment of adverse drug reactions: The occurrence and severity of adverse drug reactions (ADRs) were recorded based on patients' active reports/chart descriptions and follow-up records, and the correlation between GLP-1RAs and adverse drug reactions was evaluated using the Noether Assessment Scale, and the severity was graded.

(4) Study indicators Primary indicators: weight reduction from baseline, HbA1c Secondary indicators: medication adherence, change from baseline values of the four lipids, blood glucose fluctuation index, incidence of adverse drug reactions, total cost of GLP-1RAs during the follow-up cycle

Conditions

T2DM

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

liraglutide

No interventions assigned to this group

Dulagoside

No interventions assigned to this group

Polyethylene glycol losenatide

No interventions assigned to this group

Semaglutide

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LI YAN

OTHER

Sponsor Role: lead

Responsible Party

LI YAN

Chief Pharmacist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yining Dong, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Shandong Third Hospital

Zhongming Wu, doctor

Role: PRINCIPAL_INVESTIGATOR

Endocrine and Metabolic Disease Hospital of Shandong First Medical University

Yue Liu, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Shandong University of Traditional Chinese Medicine

Dandan Wu, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Binzhou Medical College

Jing Peng, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Jining Medical University

Qi Wang, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Jinan Fifth People's Hospital

Zhaohui Meng, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Jinan Laiwu People's Hospital

Dong wei Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

Jinan Mental Health Center

Zhong Yuan, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Jinan Municipal Hospital

Ming Xue, pharmacist

Role: PRINCIPAL_INVESTIGATOR

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

Jing Lin, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Shijhong District People's Hospital

Xingshan Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

Changqing District Hospital of Traditional Chinese Medicine

Min Fan, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Pingyin County People's Hospital

Xue Zheng, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Zibo Center Hospital

Ming Xu, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Zibo First Hospital

Yan Song, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Zibo Municipal Hospital

Ruoxun Liu, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Zibo Hospital of Traditional Chinese Medicine

Qing Zhao, doctor

Role: PRINCIPAL_INVESTIGATOR

Linzi District Maternal and Child Health Center

Zhenwei Chen, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Yiyuan County People's Hospital

Zhiyan Li, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Zaozhuang Municipal Hospital

Shenling Cheng, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Tengzhou Central People's Hospital

Qixia Zhao, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Zaozhuang Shanting District People's Hospital

Jintang Ning, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Dongying People's Hospital

Juying Ding, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Shengli Oilfield Hospital

Jiaxi Jiang, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Haiyang People's Hospital

Guichun Wang, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Longko People's Hospital

Zhentian Cheng, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Weifang Yidu Center Hospital

Yueliang Ji, doctor

Role: PRINCIPAL_INVESTIGATOR

Fangzi District People's Hospital

Donglou Liang, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Jining First People's Hospital

Li Zhang, pharmacist

Role: PRINCIPAL_INVESTIGATOR

QuFu People's Hospital

Guifeng Tan, doctor

Role: PRINCIPAL_INVESTIGATOR

Wenshang County People's Hospital

Ronghua Wang, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Weihai Maternal and Child Health Center

Jianfang Liu, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Rizhao People's Hospital

Xiangju Tian, doctor

Role: PRINCIPAL_INVESTIGATOR

Linyi Hospital of Traditional Chinese Medicine

Pengcheng Du, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Shandong University Qilu Hospital, Dezhou Hospital

Fujian Xu, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Heze Municipal Hospital

Deping Ho, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Heze Third People's Hospital

Jingyong Xue, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Heze Mudan People's Hospital

Lishun Yin, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Heze Dingtao District People's Hospital

Shengmei Wei, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Caoxian People's Hospital

Jing Meng, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Shanxian Central Hospital

Ye Fan, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Yuncheng County People's Hospital

Jingjing Zhang, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Qingdao Eighth People's Hospital

Wenqian Han, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Tai'an Central Hospital

Wenwen Lv, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Binzhou Medical College

Tao Geng, pharmacist

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Shandong First Medical University

Fang Liu, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Shengli Oilfield Hospital

Congrong Wang, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Shandong Public Health Clinical Center

Ping Wang, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Tengzhou Central People's Hospital

Yuxia Gao, pharmacist

Role: PRINCIPAL_INVESTIGATOR

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

Bo Liu, pharmacist

Role: PRINCIPAL_INVESTIGATOR

Qingdao Central Hospital

Locations

Yan Li

Jinan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

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

Role: CONTACT

dzh941213@163.com

+8618253161252

Facility Contacts

Yan Li, Doctor

Role: primary

References

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.

Reference Type: RESULT

PMID: 29397376 (View on PubMed)

Other Identifiers

QFS-LY-2024-GLP-1RA-001

Identifier Type: -

Identifier Source: org_study_id