NCT05611684

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

Nanjing First Hospital, Nanjing Medical University

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Polyethylene Glycol Losenatide	Treatment 0.2mg QW for 12 weeks

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2022-11-10
• Last updated: 2022-11-10

Locations

1 site across 1 country: China