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ENROLLING BY INVITATION
NCT07274644
PHASE4

Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus Combined With Metabolic Dysfunction-associated Steatotic Liver Disease

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

This is a single-center, randomized, open-label, controlled clinical trial to compare the effects of a fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) versus insulin glargine 100 U/mL (iGlar) on liver fat content in patients with Type 2 Diabetes (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The study includes a 12-week treatment period.

Official title: Effects of iGlarLixi Versus iGlar on Liver Fat Content in Patients With Type 2 Diabetes Mellitus With Metabolic Dysfunction-associated Steatotic Liver Disease: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-03-29

Completion Date

2026-06-30

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

DRUG

iGlarLixi

The iGlarLixi is administered as a subcutaneous injection once daily within 1 hour before breakfast. The starting dose ranges from 0.1 to 0.2 U/kg, with a maximum daily dose of 20 U (equivalent to 20 U iGlar or 20 μg Lixi). Dose titration is guided by fasting self-monitored plasma glucose (SMPG) levels, with the goal of achieving a target range of 4.4-5.6 mmol/L while avoiding hypoglycemia. All participants continue to receive background metformin therapy throughout the treatment period.

DRUG

IGlar U100

The iGlar is administered via subcutaneous injection once daily at a fixed time. The recommended starting dose ranges from 0.1 to 0.2 U/kg. The dose is subsequently titrated to achieve a fasting self-monitored plasma glucose (SMPG) target of 4.4-5.6 mmol/L, with careful attention to avoiding hypoglycemia. Throughout the study, all participants maintain their background metformin therapy

Locations (1)

Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China