Body Weight Changes, Glycemic Control, Liver Fat, Liver Fibrosis, Tolerance, Waist Circumference
Conditions
Brief summary
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
DRUGErtugliflozin 5 mg, 15mg
Ertugliflozin 5/15mg once daily in addition to standard of care
Sponsors
Getz Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiologic liver parameters | up to 24 weeks | Number of participants reported change in liver fat content from baseline, as quantified by fibroscan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight compare with baseline in 6 months | up to 24 weeks | Body Weight |
| Change in waist circumference compare with baseline in 6 months | up to 24 weeks | Waist Circumference |
| HbA1c% levels compare with baseline in 6 months | up to 24 weeks | Efficacy |
| Non-Alchoholic Fatty Liver Disease Fibrosis Score levels compare with baseline in 6 months | up to 24 weeks | Non-Alchoholic Fatty Liver Disease Fibrosis Scoring, \< -1.455 indicates Fibrosis Stage 0-2, -1.455 to 0.676 is considered indeterminate fibrosis stage, \> 0.676 indicates Fibrosis Stage 3-4 |
| Frequency of adverse events in 6 months | up to 24 weeks | Safety |
| Fibrosis 4 score levels compare with baseline in 6 months | up to 24 weeks | Fibrosis Scoring \< 1.45 indicates Fibrosis Stage 0-2, 1.45 to 3.25 is deemed indeterminate fibrosis stage, \> 3.25 indicates Fibrosis stage 3-4 |
Countries
Pakistan
Contacts
Primary ContactMuhammad Nabeed Tahir, MBBS
Backup ContactJahanzeb Kamal Khan, MBBS
Outcome results
None listed