Comprehensive Clinical Evaluation Study of GLP-1RA

ConditionT2DM
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLI YAN

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

type 2 diabetes

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

492 Participants
are grouped into 4 trial groups
Group A: liraglutide
Group B: Dulagoside
Group C: Polyethylene glycol losenatide
Group D: Semaglutide

Trial outcomes

Primary outcomes

1

HbA1c compliance rate

HbA1c\<7

Time frame
4, 8, 12, and 16 weeks after the start of medication
2

Weight reduction from baseline

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LI YAN

Lead sponsor

Qianfoshan Hospital

Sponsor institution