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Clinical Trials/EUCTR2019-001987-31-DE
EUCTR2019-001987-31-DE
Active, not recruiting
Phase 1

COMBined Active Treatment in Type 2 Diabetes with NASH - COMBAT T2 NASH

Deutsche Diabetes Forschungsgesellschaft e.V.0 sites192 target enrollmentJune 15, 2020
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ConditionsDiabetes 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 proceduresTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsJardianceOzempic

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diabetes mellitus type 2 (T2D) and non-alcoholic steatohepatitis (NASH)
Sponsor
Deutsche Diabetes Forschungsgesellschaft e.V.
Enrollment
192
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 15, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Deutsche Diabetes Forschungsgesellschaft e.V.

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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