Combined Treatment of fatty liver Inflammation and type 2 diabetes

Phase 1

• Conditions: Diabetes mellitus type 2 (T2D) and non-alcoholic steatohepatitis (NASH); MedDRA version: 21.1Level: PTClassification code 10051599Term: Diabetes mellitus managementSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-001987-31-DE
• Lead Sponsor: Deutsche Diabetes Forschungsgesellschaft e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-15
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

- Diagnosis of T2D and NASH with fibrosis stage F1-F3
- Age between 25 and 75 years
- HbA1c = 9.5%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 92

Exclusion Criteria

- Contraindications on liver biopsy
- Evidence of cirrhosis on liver biopsy
- Liver disease of other etiology
- History of ketoacidosis
- 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
- Medications that may induce steatosis
- Planned pregnancy, pregnant or lactating women, positive pregnancy
test, and woman of childbearing potential not using two adequate
methods of contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified