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

November 3, 2022 updated by: Nanjing First Hospital, Nanjing Medical University

Nanjing First Hospital, Nanjing Medical University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood sugar changes
Time Frame: 12 weeks
Effects of polyethylene glycol Losenatide on blood sugar changes in Patients With Type 2 Diabetes Mellitus.
12 weeks
blood lipid changes
Time Frame: 12 weeks
Efficacy of polyethylene glycol Losenatide on blood lipid changes in patients with type 2 diabetes
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition analysis
Time Frame: 12 weeks
Efficacy of polyethylene glycol Losenatide on body composition changes in patients with type 2 diabetes
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

October 23, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20220825-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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