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The Influencing Factors of 12 Week Efficacy of Polyethylene Glycol Losenatide in Type 2 Diabetes Patients

Sponsor
Nanjing First Hospital, Nanjing Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05611684
Collaborator
(none)
480
Enrollment
1
Location
1
Arm
43
Anticipated Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The effect of polyethylene glycol Losenatide on body fat, insulin resistance, weight, blood sugar, blood lipid, stomach volume and other factors in patients with type 2 diabetes through 12 week follow-up, and explore the factors affecting the efficacy, so as to provide more evidence-based medical basis for drug treatment and benefit patients.

Condition or Disease Intervention/Treatment Phase
  • Drug: Polyethylene Glycol Losenatide
 Phase 4

Detailed Description

The aim of the study is to investigate the factors influencing the efficacy of 12 week treatment with polyethylene glycol Losenatide in type 2 diabetes patients on the basis of diet and exercise. With the 12 week decrease of HbA1c<0.4% from the baseline as the cut-off value, the patients were divided into HbA1c decrease<0.4% group and HbA1c decrease ≥ 0.4% group. The clinical characteristics, laboratory indicators, blood glucose fluctuation of subgroups and gene spectrum differences between the groups were analyzed to provide reference for clinical accurate drug use.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
480 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Nanjing First Hospital, Nanjing Medical University
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Polyethylene Glycol Losenatide

Trearment for 12 weeks

Drug: Polyethylene Glycol Losenatide
Treatment 0.2mg QW for 12 weeks
Other Names:
  • Comparison before and after treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. blood sugar changes [12 weeks]

      Effects of polyethylene glycol Losenatide on blood sugar changes in Patients With Type 2 Diabetes Mellitus.

    2. blood lipid changes [12 weeks]

      Efficacy of polyethylene glycol Losenatide on blood lipid changes in patients with type 2 diabetes

    Secondary Outcome Measures

    1. Body composition analysis [12 weeks]

      Efficacy of polyethylene glycol Losenatide on body composition changes in patients with type 2 diabetes

    2. Inflammation factors [12 weeks]

      Effects of polyethylene glycol Losenatide on inflammation factors in Patients With Type 2 Diabetes Mellitus,after being intervened for 12 weeks,changes of Inflammation factors were observed, including adiponectin,leptin,IL-1,IL-6,IL-18,TNF-α,ghrelin,asprosin.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 2 diabetes was diagnosed according to World Health Organization(WHO) classification or other locally applicable diagnostic criteria.

    • At least 8 weeks of simple diet control and physical exercise before screening; Type 2 diabetes patients with stable hypoglycemic drug treatment and insufficient blood glucose control within 8 weeks before screening.

    • HbA1c≥7.5%.

    • Body mass index (BMI) > 24kg /m2.

    • Subjects agreed to maintain scientific diet and exercise habits throughout the study, regularly conduct self blood glucose monitoring (SMBG) and make records.

    • Willing to sign the written informed consent and abide by the research protocol.

    Exclusion Criteria:

    • Any of the following drugs or treatments were used within one year before screening: GLP-1RA, GLP-1 analogues, DPP-4 inhibitors or any other incretin analogues.

    • Long term (more than 7 consecutive days) intravenous administration, oral administration and intra-articular administration of corticosteroids received within 2 months prior to visit 1.

    • Used drugs with weight control effect or performed surgery that may lead to unstable weight within 2 months before screening, or is currently in the weight loss plan and not in the maintenance stage.

    • History of acute and chronic pancreatitis; History of myeloid C-cell carcinoma, MEN 2A or 2B syndrome, or related family history.

    • Clinically significant abnormal gastric emptying.

    • Any organ system tumors that have been treated or not treated within 5 years prior to visit 1.

    • Have received coronary angioplasty, coronary stent implantation, and coronary artery bypass surgery within 6 months prior to visit 1, and have experienced negligent compensatory heart failure (NYHA class III and IV of New York Heart Association), stroke or transient ischemic attack, unstable angina, myocardial infarction, and persistent and clinically significant arrhythmia.

    • Acute metabolic complications occurred within 6 months prior to visit 1.

    • Before screening, any laboratory test index meets the following standards: glutamic pyruvic transaminase>2.5 times or glutamic oxaloacetic transaminase>2.5 times; eGFR<45ml/min/1.73m2； Fasting triglyceride>5.64mmol /L.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jianhua Ma Nanjing Jiangsu China 210006

    Sponsors and Collaborators

    • Nanjing First Hospital, Nanjing Medical University

    Investigators

    • Study Director: Jianhua Ma, Doctor, Nanjing First Hospital, Nanjing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nanjing First Hospital, Nanjing Medical University
    ClinicalTrials.gov Identifier:
    NCT05611684
    Other Study ID Numbers:
    • KY20220825-03
    First Posted:
    Nov 10, 2022
    Last Update Posted:
    Nov 10, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Nov 10, 2022