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

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ClinicalTrials.gov Identifier: NCT05611684
Recruitment Status : Recruiting
First Posted : November 10, 2022
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

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
Type2 Diabetes Mellitus 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Polyethylene Glycol Losenatide
Trearment for 12 weeks
Drug: Polyethylene Glycol Losenatide
Treatment 0.2mg QW for 12 weeks
Other Name: Comparison before and after treatment




Primary Outcome Measures :
  1. blood sugar changes [ Time Frame: 12 weeks ]
    Effects of polyethylene glycol Losenatide on blood sugar changes in Patients With Type 2 Diabetes Mellitus.

  2. blood lipid changes [ Time Frame: 12 weeks ]
    Efficacy of polyethylene glycol Losenatide on blood lipid changes in patients with type 2 diabetes


Secondary Outcome Measures :
  1. Body composition analysis [ Time Frame: 12 weeks ]
    Efficacy of polyethylene glycol Losenatide on body composition changes in patients with type 2 diabetes

  2. Inflammation factors [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05611684


Contacts
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Contact: Jianhua Ma, Doctor +8618951670116 ext +862552887091 majianhua196503@126.com

Locations
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China, Jiangsu
Jianhua Ma Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Jianhua Ma, Professor    +8618951670116    majianhua196503@126.com   
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Study Director: Jianhua Ma, Doctor Nanjing First Hospital, Nanjing Medical University
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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT05611684    
Other Study ID Numbers: KY20220825-03
First Posted: November 10, 2022    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases