NCT02637973

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Dec 2015

Typical duration for phase_4 type-2-diabetes

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

2.7 years

First QC Date

December 16, 2015

Last Update Submit

June 2, 2023

Conditions

Type 2 DiabetesNon-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Empagliflozin, film-tablet, 25mg once daily

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

Placebo, once daily

Drug: Placebo

Interventions

EmpagliflozinDRUG

25 mg once daily

Also known as: Jardiance
Empagliflozin
PlaceboDRUG

once daily

Also known as: No Drug Therapy
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 18 and 75 years
  • BMI\<45 kg/m2
  • known diabetes duration up to 7 years
  • %≤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

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Charite Universitaetsmedizin Berlin

Berlin, Germany

Location

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, 01307, Germany

Location

German Diabetes Center

Düsseldorf, Germany

Location

University Clinic Heidelberg

Heidelberg, Germany

Location

University Clinic Tübingen

Tübingen, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver Disease

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Michael Roden, MD

    Deutsches Diabetes Zentrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 22, 2015

Study Start

December 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

June 5, 2023

Record last verified: 2023-06

Locations

DE(5)