Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT06686134
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
Study:
NCT06686134
Study Brief:
Protocol Section:
NCT06686134