Effects of Empagliflozin on Liver Fat Content, Energy Metabolism and Body Composition in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The effects of empagliflozin treatment on hepatocellular lipid content, liver energy metabolism and body composition will be investigated in a multicentre, prospective, placebo-controlled, double-blind, randomized, 2-arm parallel, interventional and exploratory pilot study in patients with newly diagnosed type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Deutsche Diabetes Forschungsgesellschaft e.V.
• Collaborator: Boehringer Ingelheim
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• age between 18 and 75 years

• BMI<45 kg/m2

• known diabetes duration up to 7 years

• 6%≤HbA1c≤8%

• drug naïve - no previous antihyperglycemic treatment or one month washout period of treatment with oral glucose lowering drugs (no previous treatment with thiazolidinedione (TZD) drugs allowed)

• obtained written informed consent

Exclusion Criteria:

• uncontrolled hyperglycaemia at screening (glucose level ≥240 mg/dl after an overnight fast, confirmed by a second measurement)

• acute coronary syndrome, stroke or transient ischemic attack within 3 months prior to consent

• previous lower limb amputation

• severe lower limb infection/ulceration within 3 months prior to consent

• liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis, or liver cirrhosis of any etiology

• AST or ALT > 3 x ULN

• positive result on hepatitis B (HBs-AG), hepatitis C (HCV-AB), or HIV 1 and 2 test

• impaired kidney function (estimated glomerular filtration rate [eGFR]<60 mL/min/1.73m2) during screening

• structural and functional urogenital abnormalities, that predispose for urogenital infections

• gastrointestinal surgeries that induce chronic malabsorption

• history of cancer (except basal cell carcinoma) or treatment for cancer within 5 years

• blood dyscrasias or any disorders causing haemolysis or unstable erythrocytes

• treatment with antiobesity drugs 3 months prior to consent

• treatment with immunomodulatory drugs (oral steroids, antihistamines)

• change in dosage of thyroid hormones within 6 weeks of consent

• pregnancy, lactation period

• metal or magnetic implants, devices or objects inside of or on the body, which are not MRI compatible (according to MRT safety checklist in Appendix 11.3)

• claustrophobia

• cigarette smoking (non-smoker < 1year), alcohol consumption (male >30 g/d, female >20g/d)

• drug abuse or psychiatric disease

• night-worker or circumstances not allowing normal day-night rhythm

• hypersensitivity to empagliflozin (or drugs of similar chemical structure) or any of the drug compounds

• pharmaceutical preparations with which interactions can be expected - amiloride, furosemide, indapamide, spironolactone, torasemide, triamterene

• use of anti-NASH drugs (vitamin E, ursodeoxycholic acid, S-adenosylmethionine, betaine, silymarin, gemfibrozil, anti-TNF therapies, probiotics) in the 3 months prior to randomization

• women of childbearing potential not using two adequate methods of contraception including a barrier method and a highly efficacious non-barrier method

• persons with any kind of dependency on the investigator or employed by the sponsor or investigator

• persons held in an institution by legal or official order

• participation in another trial in the last 10 weeks before randomization or planned participation during the trial period