Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

NCT05140694 | Unknown Phase 4

• 1 other identifier: MAFLD_empa_dula
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metabolic-associated Fatty Liver Disease; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Changes of HbA1c level

  Patients achieving the target level

  baseline, week 12, week 24

• Changes of CAP score

  Controlled Attenuation Parameter (CAP) score by transient elastography

  baseline, week 24

Secondary Outcomes (9)

• Changes of LSM score

  baseline, week 24

• Changes of noninvasive liver fibrosis markers

  baseline, week 12, week 24

• Changes of body weight and body composition

  baseline, week 24

• Changes of lipid levels

  baseline, week 12, week 24

• Changes of ketone levels

  baseline, week 12, week 24

Other Outcomes (3)

• Changes of urine markers

  baseline, week 12, week 24

• Changes of bone health

  baseline, week 12, week 24

• Changes of gut microbiota

  baseline, week 24

Study Arms (3)

Empagliflozin

EXPERIMENTAL

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

Drug: Empagliflozin

Dulaglutide

EXPERIMENTAL

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

Drug: Dulaglutide

Empagliflozin and Dulagludie

EXPERIMENTAL

Empagliflozin 10mg p.o. once daily and dulaglutide 0.75mg s.c. once weekly

Drug: Empagliflozin and Dulaglutide

Interventions

Empagliflozin DRUG

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

Also known as: Jardiance

Empagliflozin

Dulaglutide DRUG

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

Also known as: Trulicity

Dulaglutide

Empagliflozin and Dulaglutide DRUG

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

Also known as: Jardiance and Trulicity

Empagliflozin and Dulagludie

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 20 or over
• uncontrolled HbA1c (7\~10%) with metformin and/or sulfonylurea
• Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m)
• MAFLD: presence of any conditions
• Overweight or obese: BMI ≥23 kg/m2 (Asian)
• 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

You may not qualify if:

• Significant alcohol consumption
• 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
• Type 1 diabetes mellitus
• medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs
• Severe organ dysfunction
• liver damage: AST/ALT \>x5 UNL, albumin \<3.2, platelet \<60k, Child-Pugh-Turcotte stage B or C
• kidney damage: serum creatinine ≥2.0 mg/dL or eGFR \<50 mL/min/1.72m2
• Hepatocellular carcinoma, active tumor, or metastasis
• End-stage liver disease

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Soo Lim, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Lim, MD, PhD

CONTACT

+82-31-787-7035; limsoo@snu.ac.kr

Minji Sohn, PhD

CONTACT

+82-31-787-8443; rainbowmjs@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: December 1, 2021
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2025
• Last Updated: October 4, 2022

Record last verified: 2022-10