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Trial · Observational

RecruitingPhase not statedRegistry data

Comprehensive Clinical Evaluation Study of GLP-1RA

NCTNCT06686134 (opens ClinicalTrials.gov in a new tab)Other idQFS-LY-2024-GLP-1RA-001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase not stated
Enrollment
492 participants (estimated)
Sponsor
LI YAN · Other
Design
Not stated
Countries
1 country

China

Start
1 Jul 2024
Primary completion
31 Dec 2025 (estimated)
Completion
31 Jul 2026 (estimated)
First posted
13 Nov 2024
Last update posted
13 Nov 2024
Conditions
T2DM

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph –

    Comprehensive Clinical Evaluation Study of GLP-1RA

    NCT06686134

    1 Jul 2024 to est. 31 Jul 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Arms4

  • Other

    liraglutide

  • Other

    Dulagoside

  • Other

    Polyethylene glycol losenatide

  • Other

    Semaglutide

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. HbA1c compliance rate

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

    Registry description

    HbA1c\<7

  2. Weight reduction from baseline

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

21 results

Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial.

Pratley et al. 2018The lancet. Diabetes & endocrinologycited by 614

PMID 29397376DOI 10.1016/s2213-8587(18)30024-xPUB-29397376

Full text at the publisher21 results
Publisher pageSee results (21)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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