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临床试验/NCT04976283
NCT04976283Unknown4 期

Which Oral Combination of Anti-diabetes Medication May Work Better in Subjects With Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: a Randomized Control Trial

Getz Pharma1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2021年9月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
123
试验地点
1
主要终点
Change in radiologic liver parameters

研究概览

简要总结

This randomized clinical trial aims to compare the effect of the pioglitazone and SGLT2 inhibitor combination on liver fat mass, as compared to either drug used alone, with or without background medical therapy of metformin and/or DDP4 inhibitors.

详细描述

To compare the effect of pioglitazone with or without Metformin and/or DPP4 inhibitor (no SGLT2 inhibitor) on improvement of NAFLD parameters, versus

The effect of SGLT inhibitor with or without metformin and/or DPP4 inhibitor (no pioglitazone) on NAFLD parameters and versus

Pioglitazone with or without metformin and/or DPP4 inhibitor, plus empagliflozin on improvement of NAFLD parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who give informed consent voluntarily
  • Type 2 diabetic patient having age from 18 years to 60 years
  • HbA1C ≥ 7.0 %
  • Diabetes diagnosis of ≤ 5 years (longer duration more likely to be associated with use of multiple drug regimens for glycemic control which may affect liver fat mass)
  • Either treatment naïve or on metformin alone or metformin/DPP4i combination
  • Absolute weight < 100kg; BMI < 45 (fibro scan machine cannot accommodate heavier individuals)
  • Documented hepatosteatosis (If the fibroscan reveals S1 (mild fatty liver: 11-33% fatty liver) to S3 (severe fatty liver: > 67% fatty liver) liver fat

排除标准

  • Hba1c ≥ 9% and/or blood sugar > 250mg/dl
  • History of uncontrolled Endocrine disorder (for example uncontrolled hypothyroidism, or that requiring frequent dose adjustment, or Cushings syndrome)
  • History of anti-obesity medication use within 3 months of consent for study enrollment or weight loss procedure(bariatric surgery) within same duration
  • History of use of SGLT 2 inhibitors, glitazones, Glucagon-like peptide (GLP) 1 agonists 3 months prior to study enrollment as they influence liver fat
  • History of use of insulin/sulphonylurea 3 months prior to study enrollment owing to weight gain and potential increase in liver fat conferred by these agents
  • History of vitamin E use (400mg twice daily) within 3 months of study enrollment
  • Drug induced liver disease or active substance abuse (cannabonnoid-derived substances like heroin, cocaine, amphetamines) based on history and/or laboratory tests
  • Drugs known to be associated with hepatic steatosis like steroids, traditional homeopathic medication (likely to contain steroids), methotrexate, valproate, tamoxifen, amiodarone.
  • Alcohol use (History of alcoholism or a greater than recommended alcohol intake (> 21 standard drinks on average per week in men and > 14 standard drinks on average per week in women)
  • Severe hepatic impairment (ALT levels > 3 times upper limit normal)
  • Hepatitis B/C hepatitis (based on positive Hepatitis B surface antigen, Anti Hepatitis C antibodies positive
  • Autoimmune hepatitis (in case of females), based on positive Anti-nuclear Antibody (ANA) (homogenous, high titre)
  • Positive Human Immunodeficiency Virus ( HIV) test as this could influence liver functions
  • Pregnant or lactating women/ plans for pregnancy over proceeding 13 months
  • Obstructive liver disease on the basis of laboratory and imaging studies
  • Chronic renal failure, or Glomerular Filtration Rate (GFR) < 30 mls/minute (as estimated by the MDRD equation)
  • Chronic heart failure, history of acute coronary artery disease or cerebrovascular accident within 3 months of consent for study enrollment, based on history and/or cardiac imaging
  • History of recurrent Urinary Tract Infections (UTI's) or mycotic infections
  • Presence of ketones on Urine Analysis

研究组 & 干预措施

Pioglitazone

Active Comparator

The starting dose would be 15mg/day for pioglitazone and 500 to 1500mg per day for metformin (depending on blood glucose levels). Starting dose for DPP4 inhibitors would be 50 to 100mg daily.

干预措施: Pioglitazone (Drug)

Empagliflozin

Active Comparator

The starting dose would be 500-1500mg/day of metformin, plus 5/10/12.5mg empagliflozin (depending on blood glucose levels). Starting dose for DPP4 inhibitors would be 50 to 100mg daily.

干预措施: Empagliflozin (Drug)

Pioglitazone + Empagliflozin

Active Comparator

The starting dose would be 15mg/day for pioglitazone and 500 to1500mg per day for metformin and 5/10/12.5mg/25mg/day empagliflozin and 50 to 100mg daily for DPP4 inhibitors depending on blood sugar levels.

干预措施: Pioglitazone + Empagliflozin (Drug)

结局指标

主要结局

Change in radiologic liver parameters

时间窗: 12 months

Number of participants reported change in liver fat content from baseline, as quantified by fibroscan

次要结局

  • Change in body weight(12 months)
  • Change in liver enzymes(12 months)
  • Change in waist circumference (WC)(12 months)
  • Change in Fibrosis-4 (FIB-4) Score and NAFLD Fibrosis Score(12 months)
  • Change in liver fat mass with total body fat (TBF)(12 months)
  • Change in Fasting Blood Sugar (FBS)(12 months)
  • Change in Lipid profile(12 months)
  • Change in HbA1C levels (< 7.0%)(12 months)

研究者

发起方
Getz Pharma
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Dr. Najmul Islam

Professor Endocrinology, Diabetes

Aga Khan University

研究点 (1)

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