Comprehensive Clinical Evaluation Study of GLP-1RA

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.

Study Overview

• Status: Recruiting
• Conditions: T2DM

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

• Study Type: Observational
• Enrollment (Estimated): 492

Contacts and Locations

• Study Contact: Name: Dong Zhonghua The First Affiliated Hospital of Shandong First Medical Univer, master; Phone Number: +8618253161252; Email: dzh941213@163.com

Study Locations

• China
  • Jinan, China
    • Recruiting
    • Yan Li
    • Contact: Yan Li, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

type 2 diabetes

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
liraglutide
Dulagoside
Polyethylene glycol losenatide
Semaglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: LI YAN
• Investigators: Principal Investigator: 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, Affiliated Hospital of Jining Medical College; 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 Central 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 Central 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Estimated): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: GLP1-RA
• Other Study ID Numbers: QFS-LY-2024-GLP-1RA-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No