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.
This study is designed as a single-center, randomized, open-label, parallel controlled trial. A total of 36 participants with T2DM and MASLD (defined by MRI-PDFF ≥10%) will be randomized in a 1:1 ratio to receive either once-daily iGlarLixi or iGlar, both in combination with metformin, for 12 weeks. The primary outcome is the change in liver fat content assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF) from baseline to week 12. Key secondary outcomes include changes in liver enzymes, liver inflammation, fibrosis indices (assessed by transient elastography and FIB-4 index), body composition (weight, BMI, waist circumference, waist-to-hip ratio, and visceral fat area), glycemic control (HbA1c, fasting and postprandial glucose), insulin function, lipid profiles, and uric acid. Safety assessments will include monitoring of hypoglycemic events, gastrointestinal adverse events, and other adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
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
Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Absolute change from baseline to Week 12 in hepatic fat fraction
The absolute change of liver fat content were measured by MRI-PDFF
Time frame: Baseline, Week 12
Percent change from baseline to Week 12 in hepatic fat fraction
The relative changes of liver fat content were measured by MRI-PDFF
Time frame: Baseline, Week 12
Percentage of participants with at least 30% relative fat reduction at Week 12
The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% as measured by MRI-PDFF at Week 12.
Time frame: week 12
Changes of liver transaminase
The changes of liver transaminase were measured by ALT, AST, γ-GGT.
Time frame: Baseline, 12 weeks
Changes of liver inflammation index
The changes of liver inflammation index were measured by TE.
Time frame: Baseline, 12 weeks
Changes of liver stiffness measurement
The changes of liver stiffness measurement were measured by MRE.
Time frame: Baseline, 12 weeks
Changes of FIB-4 index
The changes of liver fibrosis can be measured by FIB-4 index.
Time frame: Baseline, 12 weeks
Changes of body weight
The changes of body weight were measured by InBody-770 equipment.
Time frame: Baseline, 12 weeks
Changes of visceral fat area
The changes of visceral fat area were measured by InBody-770 equipment.
Time frame: Baseline, Week 12
Changes of percent body fat
The changes of percent body fat were measured by InBody-770 equipment.
Time frame: Baseline, Week 12
Changes of skeletal muscle mass index
The changes of skeletal muscle mass index were measured by InBody-770 equipment.
Time frame: Baseline, Week 12
Changes of HbA1c
The changes of glucose metabolism indexes were measured by HbA1c.
Time frame: Baseline, 12 weeks
Changes of plasma glucose
The changes of glucose metabolism indexes were measured by fasting plasma glucose and 2-h postprandial plasma glucose.
Time frame: Baseline, 12 weeks
Changes of C-peptide
The changes of glucose metabolism indexes were measured by fasting C-peptide and 2-h postprandial C-peptide.
Time frame: Baseline, 12 weeks
Changes of lipid metabolism indexes
The changes of lipid metabolism indexes were measured by triglyceride, total cholesterol, high-density and low-density lipoprotein-cholesterol.
Time frame: Baseline, 12 weeks
Changes of uric acid
Changes of uric acid will be assessed and compared between treatment groups.
Time frame: Baseline, Week 12
Changes of urine albumin to creatinine ratio
Changes of urine albumin to creatinine ratio will be assessed and compared between treatment groups.
Time frame: Baseline, Week 12
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