Combined Active Treatment in Type 2 Diabetes With NASH

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this multicentre, prospective, placebo-controlled, double-blind, randomized, 3-arm parallel group, interventional study is to assess for the first time the effects of either a combined therapy with the antihyperglycemic drugs semaglutide and empagliflozin or empagliflozin monotherapy compared to placebo as potential treatments for non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes.

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

Details

• Lead Sponsor: The Deutsche Diabetes Forschungsgesellschaft e.V.
• Collaborators: Boehringer Ingelheim; Federal Ministry of Health, Germany; German Center for Diabetes Research; Ministry of Innovation, Science and Research in North Rhine-Westphalia; Novo Nordisk A/S
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Diagnosis of T2D and NASH with fibrosis stage F1-F3

• Age between 25 and 75 years

• HbA1c ≤ 9.5%

• BMI ≤ 45 kg/m2

• obtained written informed consent

Exclusion Criteria:

• Contraindications on liver biopsy

• Evidence of cirrhosis on liver biopsy

• Liver disease of other etiology 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

• History of diabetic ketoacidosis

• Current treatment with immunomodulatory drugs (oral/intravenous steroids on > 7 consecutive days, methotrexate, amiodarone, biologicals)

• Alcohol consumption >30 g/d for males and >20 g/d for females

• Past (≥5 years) or current history of alcohol or drug abuse and/or psychiatric disease including severe depression necessitating pharmacological treatment

• Medications that induce steatosis: estrogen or other hormonal replacement therapy (except oral contraception), tamoxifen, raloxifene, oral glucocorticoids or chloroquine

• Planned pregnancy, pregnant or lactating women, positive pregnancy test, and woman of childbearing potential not using two adequate methods of contraception, including a barrier method and a highly efficacious non-barrier method