Clinical trial NCT06686134: Comprehensive Clinical Evaluation Study of GLP-1RA
Official title: Comprehensive Clinical Evaluation Study of GLP-1RA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: T2DM
Keywords: GLP1-RA
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: type 2 diabetes

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

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.

Primary outcomes:
measure: HbA1c compliance rate
timeFrame: 4, 8, 12, and 16 weeks after the start of medication
measure: Weight reduction from baseline
timeFrame: 4, 8, 12, and 16 weeks after the start of medication
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Yan Li
Study officials:
affiliation: Shandong Third Hospital
name: Yining Dong, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrine and Metabolic Disease Hospital of Shandong First Medical University
name: Zhongming Wu, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong University of Traditional Chinese Medicine
name: Yue Liu, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Binzhou Medical College
name: Dandan Wu, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Jining Medical University
name: Jing Peng, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinan Fifth People's Hospital
name: Qi Wang, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinan Laiwu People's Hospital
name: Zhaohui Meng, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinan Mental Health Center
name: Dong wei Wang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinan Municipal Hospital
name: Zhong Yuan, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinan Hospital, Guang'anmen Hospital, China Academy of Traditional Chinese Medicine, China
name: Ming Xue, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Shijhong District People's Hospital
name: Jing Lin, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Changqing District Hospital of Traditional Chinese Medicine
name: Xingshan Wang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Pingyin County People's Hospital
name: Min Fan, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Zibo Center Hospital
name: Xue Zheng, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Zibo First Hospital
name: Ming Xu, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Zibo Central Hospital
name: Yan Song, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Zibo Hospital of Traditional Chinese Medicine
name: Ruoxun Liu, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Linzi District Maternal and Child Health Center
name: Qing Zhao, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Yiyuan County People's Hospital
name: Zhenwei Chen, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Zaozhuang Municipal Hospital
name: Zhiyan Li, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Tengzhou Central People's Hospital
name: Shenling Cheng, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Zaozhuang Shanting District People's Hospital
name: Qixia Zhao, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongying People's Hospital
name: Jintang Ning, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengli Oilfield Hospital
name: Juying Ding, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Haiyang People's Hospital
name: Jiaxi Jiang, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Longko People's Hospital
name: Guichun Wang, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Weifang Yidu Center Hospital
name: Zhentian Cheng, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Fangzi District People's Hospital
name: Yueliang Ji, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Jining First People's Hospital
name: Donglou Liang, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: QuFu People's Hospital
name: Li Zhang, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Wenshang County People's Hospital
name: Guifeng Tan, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Weihai Maternal and Child Health Center
name: Ronghua Wang, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Rizhao People's Hospital
name: Jianfang Liu, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Linyi Hospital of Traditional Chinese Medicine
name: Xiangju Tian, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong University Qilu Hospital, Dezhou Hospital
name: Pengcheng Du, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Heze Municipal Hospital
name: Fujian Xu, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Heze Third People's Hospital
name: Deping Ho, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Heze Mudan People's Hospital
name: Jingyong Xue, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Heze Dingtao District People's Hospital
name: Lishun Yin, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Caoxian People's Hospital
name: Shengmei Wei, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanxian Central Hospital
name: Jing Meng, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Yuncheng County People's Hospital
name: Ye Fan, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Qingdao Eighth People's Hospital
name: Jingjing Zhang, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Tai'an Central Hospital
name: Wenqian Han, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Binzhou Medical College
name: Wenwen Lv, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Shandong First Medical University
name: Tao Geng, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengli Oilfield Hospital
name: Fang Liu, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Public Health Clinical Center
name: Congrong Wang, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Tengzhou Central People's Hospital
name: Ping Wang, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongying Hospital Affiliated to Shandong University of Traditional Chinese Medicine (Dongying Hospital of Traditional Chinese Medicine)
name: Yuxia Gao, pharmacist
role: PRINCIPAL_INVESTIGATOR
affiliation: Qingdao Central Hospital
name: Bo Liu, pharmacist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.