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

NCT ID: NCT05611684

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-12-31

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.

Conditions

Type2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Polyethylene Glycol Losenatide

Trearment for 12 weeks

Group Type: EXPERIMENTAL

Polyethylene Glycol Losenatide

Intervention Type: DRUG

Treatment 0.2mg QW for 12 weeks

Interventions

Polyethylene Glycol Losenatide

Treatment 0.2mg QW for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Comparison before and after treatment

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianhua Ma, Doctor

Role: STUDY_DIRECTOR

Nanjing First Hospital, Nanjing Medical University

Locations

Jianhua Ma

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianhua Ma, Doctor

Role: CONTACT

majianhua196503@126.com

+8618951670116 ext. +862552887091

Facility Contacts

Jianhua Ma, Professor

Role: primary

majianhua196503@126.com

+8618951670116

Other Identifiers

KY20220825-03

Identifier Type: -

Identifier Source: org_study_id