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

Primary Purpose

Type2 Diabetes Mellitus

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Polyethylene Glycol Losenatide
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jianhua MaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Polyethylene Glycol Losenatide

Arm Description

Trearment for 12 weeks

Outcomes

Primary Outcome Measures

blood sugar changes
Effects of polyethylene glycol Losenatide on blood sugar changes in Patients With Type 2 Diabetes Mellitus.
blood lipid changes
Efficacy of polyethylene glycol Losenatide on blood lipid changes in patients with type 2 diabetes

Secondary Outcome Measures

Body composition analysis
Efficacy of polyethylene glycol Losenatide on body composition changes in patients with type 2 diabetes
Inflammation factors
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.

Full Information

First Posted
October 23, 2022
Last Updated
November 3, 2022
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05611684
Brief Title
The Influencing Factors of 12 Week Efficacy of Polyethylene Glycol Losenatide in Type 2 Diabetes Patients
Official Title
Nanjing First Hospital, Nanjing Medical University
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polyethylene Glycol Losenatide
Arm Type
Experimental
Arm Description
Trearment for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol Losenatide
Other Intervention Name(s)
Comparison before and after treatment
Intervention Description
Treatment 0.2mg QW for 12 weeks
Primary Outcome Measure Information:
Title
blood sugar changes
Description
Effects of polyethylene glycol Losenatide on blood sugar changes in Patients With Type 2 Diabetes Mellitus.
Time Frame
12 weeks
Title
blood lipid changes
Description
Efficacy of polyethylene glycol Losenatide on blood lipid changes in patients with type 2 diabetes
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body composition analysis
Description
Efficacy of polyethylene glycol Losenatide on body composition changes in patients with type 2 diabetes
Time Frame
12 weeks
Title
Inflammation factors
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Ma, Doctor
Phone
+8618951670116
Ext
+862552887091
Email
majianhua196503@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma, Doctor
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Jianhua Ma
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma, Professor
Phone
+8618951670116
Email
majianhua196503@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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