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Recruiting NCT05644717

Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD

Phase IV Interventional Liver Fat Liver Fibrosis Glycemic Control Body Weight Changes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ertugliflozin 5 mg, 15mg.
Who it may be relevant to
Registry conditions: Liver Fat, Liver Fibrosis, Glycemic Control, Body Weight Changes. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Ertugliflozin on Liver Fat, Liver Fibrosis & Glycemic Control in Subjects With Type 2 Diabetes Mellitus (T2DM) & Non-Alcoholic Fatty Liver Disease /Non-Alcoholic Steatohepatitis

Overview

Open-label, prospective, single-arm, multicenter study to determine effects of Ertugliflozin on liver fat, liver fibrosis \& glycemic control in subjects with Type 2 Diabetes Mellitus (T2DM) with Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH)

Interventions

  • Drug Ertugliflozin 5 mg, 15mg
    Ertugliflozin 5/15mg once daily in addition to standard of care

Primary outcome measures

  • Radiologic liver parameters [Time frame: up to 24 weeks]
Secondary outcome measures (6)
  • HbA1c% levels compare with baseline in 6 months [Time frame: up to 24 weeks]
  • Change in body weight compare with baseline in 6 months [Time frame: up to 24 weeks]
  • Change in waist circumference compare with baseline in 6 months [Time frame: up to 24 weeks]
  • Fibrosis 4 score levels compare with baseline in 6 months [Time frame: up to 24 weeks]
  • Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months [Time frame: up to 24 weeks]
  • Frequency of adverse events in 6 months [Time frame: up to 24 weeks]

Eligibility criteria

Inclusion criteria

  • Patient able to provide written informed consent
  • Adult males \& females between 18 to 65 years
  • SGLT2i and insulin naïve patients
  • BMI >23 Kg/m2
  • HbA1C % ≥ 6.5 to 10
  • Documented hepatic steatosis or fatty liver disease on Ultrasound
  • Patient with Type II Diabetes Mellitus

Exclusion criteria

  • History of use of SGLT 2 inhibitors or Glucagon-like peptide (GLP) 1 agonist or insulin; 3 months prior to enrollment in the study.
  • Pioglitazone use in the past 6 months
  • History of vitamin E use (400mg twice daily) 3 months prior to enrollment in the study.
  • History of anti-obesity medication or weight loss procedure (bariatric surgery) use within 3 months prior to enrollment in the study.
  • History of uncontrolled Endocrine disorder (for example uncontrolled hypothyroidism, or that requires frequent dose adjustment, or Cushing's syndrome)
  • History of liver disease including viral hepatitis, auto-immune hepatitis, liver cirrhosis, hepatocellular carcinoma and/or HIV
  • History of recurrent UTIs and mycotic infection.
  • Severely ill patients (who have high grade fever, sepsis or acute infection)
  • Pregnant woman, lactating woman or planning pregnancy during study duration
  • History of Drug-induced liver disease (e.g. amiodarone, valproate, tamoxifen, methotrexate, steroids (including homeopathic medicines).
  • History of active substance abuse (cannabinoid-derived substances like heroin, cocaine, amphetamines) based on history and/or laboratory tests
  • Alcohol intake 10 - 30 g/day (three drinks per day) within the previous year
  • Active substance abuse such as acetaminophen over-use, hashish, tobacco products, heroin, cocaine or amphetamines.
  • Severe hepatic impairment ( AST \& ALT levels > 3 times upper limit normal

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • North west general hospital — Peshawar

Publications

  • Hu M, Phan F, Bourron O, Ferre P, Foufelle F. Steatosis and NASH in type 2 diabetes. Biochimie. 2017 Dec;143:37-41. doi: 10.1016/j.biochi.2017.10.019. Epub 2017 Oct 31. PMID 29097281
  • Targher G, Byrne CD, Lonardo A, Zoppini G, Barbui C. Non-alcoholic fatty liver disease and risk of incident cardiovascular disease: A meta-analysis. J Hepatol. 2016 Sep;65(3):589-600. doi: 10.1016/j.jhep.2016.05.013. Epub 2016 May 17. PMID 27212244
  • Mantovani A, Byrne CD, Bonora E, Targher G. Nonalcoholic Fatty Liver Disease and Risk of Incident Type 2 Diabetes: A Meta-analysis. Diabetes Care. 2018 Feb;41(2):372-382. doi: 10.2337/dc17-1902. PMID 29358469
  • Mantovani A, Zaza G, Byrne CD, Lonardo A, Zoppini G, Bonora E, Targher G. Nonalcoholic fatty liver disease increases risk of incident chronic kidney disease: A systematic review and meta-analysis. Metabolism. 2018 Feb;79:64-76. doi: 10.1016/j.metabol.2017.11.003. Epub 2017 Nov 11. PMID 29137912
  • Schuppan D, Schattenberg JM. Non-alcoholic steatohepatitis: pathogenesis and novel therapeutic approaches. J Gastroenterol Hepatol. 2013 Aug;28 Suppl 1:68-76. doi: 10.1111/jgh.12212. PMID 23855299
  • Gusdon AM, Song KX, Qu S. Nonalcoholic Fatty liver disease: pathogenesis and therapeutics from a mitochondria-centric perspective. Oxid Med Cell Longev. 2014;2014:637027. doi: 10.1155/2014/637027. Epub 2014 Oct 13. PMID 25371775

Identifiers

NCT: NCT05644717 · GTZ_DM_007_22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗