Current partner codePEPTIDESDE
NCT05140694·Phase 4·INTERVENTIONAL

Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

Status

Unknown

Phase

Phase 4

Enrollment

135

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The co-administration of SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and MAFLD better than empagliflozin or dulaglutide alone. The SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on fatty liver disease in subjects with type 2 diabetes mellitus and MAFLD.

Interventions

Treatment arms and agents.

DRUG

Empagliflozin

Empagliflozin 10 mg p.o. once daily (available to control over \~25mg)

DRUG

Dulaglutide

Dulaglutide 0.75mg s.c. once a week (available to control over \~1.5mg)

DRUG

Empagliflozin and Dulaglutide

Empagliflozin 10 mg p.o. once daily with Dulaglutide 0.75mg s.c. once weekly

Timeline

From registration to results.

  1. First posted

    Dec 1, 2021

  2. Study start

    Dec 1, 2023

  3. Primary completion

    Jun 30, 2024

  4. Study completion

    Dec 31, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Oct 4, 2022

Outcomes

What the study measures.

Primary outcomes

Changes of HbA1c level

Time frame · baseline, week 12, week 24

Patients achieving the target level

Changes of CAP score

Time frame · baseline, week 24

Controlled Attenuation Parameter (CAP) score by transient elastography

Secondary outcomes

Changes of LSM score

Time frame · baseline, week 24

Liver stiffness measurement (LSM) score by transient elastography

Changes of noninvasive liver fibrosis markers

Time frame · baseline, week 12, week 24

Noninvasive liver fibrosis markers will be calculated at baseline and at the end of the study

Changes of body weight and body composition

Time frame · baseline, week 24

Body composition by bioelectrical impedance will be measured at baseline and at the end of the study

Changes of lipid levels

Time frame · baseline, week 12, week 24

Cholesterol level will be measured at all visit days

Changes of ketone levels

Time frame · baseline, week 12, week 24

Ketone level will be measured at all visit days

Changes of liver parenchyma by ultrasonography

Time frame · baseline, week 24

improvement or deterioration

Changes of liver function parameters

Time frame · baseline, week 12, week 24

Liver enzymes, albumin will be measured at all visit days.

Changes of liver fibrosis biomarkers

Time frame · baseline, week 24

Type IV collagen

Changes of inflammation biomarker

Time frame · baseline, week 24

high-sensitivity CRP

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
90 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. age 20 or over 2. uncontrolled HbA1c (7\~10%) with metformin and/or sulfonylurea 3. Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m) 4. MAFLD: presence of any conditions 1. Overweight or obese: BMI ≥23 kg/m2 (Asian) 2. Metabolic dysregulation: at least of two of following criteria * Waist circumference: ≥90/80 cm in men and women (Asian) * Blood pressure ≥130/85 mmHg or drug treatment * Plasma triglycerides ≥150 mg/dL or drug treatment * Plasma HDL-cholesterol \<40/50 mg/dL for men and women or drug treatment * Prediabetes (i.e. fasting glucose levels 100 to 125 mg/dL or 2-hour post-load glucose levels 140 to 199 mg/dL or HbA1c 5.7% to 6.4% * HOMA-insulin resistance score ≥2.5 * Plasma high-sensitivity CRP \>2 mg/L Exclusion Criteria: 1. Significant alcohol consumption 2. Other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1 anti-trypsin deficiency, Celiac disease, Overt hypothyroidism, other secondary causes 3. Type 1 diabetes mellitus 4. medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs 5. Severe organ dysfunction 1. liver damage: AST/ALT \>x5 UNL, albumin \<3.2, platelet \<60k, Child-Pugh-Turcotte stage B or C 2. kidney damage: serum creatinine ≥2.0 mg/dL or eGFR \<50 mL/min/1.72m2 6. Hepatocellular carcinoma, active tumor, or metastasis 7. End-stage liver disease

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.