Type 2 Diabetes Clinical Trial
— EmLiFaOfficial title:
Effects of Empagliflozin on Liver Fat Content, Energy Metabolism and Body Composition in Patients With Type 2 Diabetes
NCT number | NCT02637973 |
Other study ID # | EmLiFa001 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 2015 |
Est. completion date | August 2018 |
Verified date | June 2023 |
Source | German Diabetes Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charite Universitaetsmedizin Berlin | Berlin | |
Germany | Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden | Dresden | |
Germany | German Diabetes Center | Dusseldorf | |
Germany | University Clinic Heidelberg | Heidelberg | |
Germany | University Clinic Tübingen | Tübingen |
Lead Sponsor | Collaborator |
---|---|
The Deutsche Diabetes Forschungsgesellschaft e.V. | Boehringer Ingelheim |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in liver fat content | Change in liver fat content between baseline and 24 weeks measured with magnetic resonance spectroscopy | from baseline to 24 weeks |
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