NCT05611684

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 10, 2022

Status Verified

September 1, 2022

Enrollment Period

1.6 years

First QC Date

October 23, 2022

Last Update Submit

November 3, 2022

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • blood sugar changes

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

    12 weeks

  • blood lipid changes

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

    12 weeks

Secondary Outcomes (2)

  • Body composition analysis

    12 weeks

  • Inflammation factors

    12 weeks

Study Arms (1)

Polyethylene Glycol Losenatide

EXPERIMENTAL

Trearment for 12 weeks

Drug: Polyethylene Glycol Losenatide

Interventions

Polyethylene Glycol LosenatideDRUG

Treatment 0.2mg QW for 12 weeks

Also known as: Comparison before and after treatment
Polyethylene Glycol Losenatide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianhua Ma

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Interventions

Aftercare

Intervention Hierarchy (Ancestors)

Continuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Jianhua Ma, Doctor

    Nanjing First Hospital, Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Jianhua Ma, Doctor

CONTACT

+8618951670116majianhua196503@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2022

First Posted

November 10, 2022

Study Start

June 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

November 10, 2022

Record last verified: 2022-09

Locations

CN(1)