Type 2 DiabetesPhase 4EmLiFaNCT02637973
Effects of Empagliflozin on Liver Fat Content, Energy Metabolism and Body Composition in Patients With Type 2 Diabetes
A Phase 4 study testing Empagliflozin in people with Type 2 Diabetes and Non-alcoholic Fatty Liver Disease, run by The Deutsche Diabetes Forschungsgesellschaft e.V. at 5 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Non-alcoholic Fatty Liver Disease
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 5 sitesGermany
- Study dates
- Dec 2015to Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Charite Universitaetsmedizin Berlin
Berlin
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, 01307
German Diabetes Center
Düsseldorf
University Clinic Heidelberg
Heidelberg
University Clinic Tübingen
Tübingen
About this study
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.
Read the detailed description
In this multicentre, prospective, placebo-controlled, double-blind, randomized, 2-arm parallel, interventional pilot study HCL and intramyocellular lipids (IMCL) will be quantified with 1H magnetic resonance (MR) spectroscopy. Hepatic ATP and inorganic phosphate (Pi) concentrations will be assessed with 31P MR spectroscopy (1). Whole-body and hepatic insulin sensitivity and metabolic flexibility will be measured by combining hyperinsulinemic-euglycemic pancreatic clamp tests with isotopic dilution of 6,6-2H2 glucose and indirect calorimetry as shown (2). Abdominal fat distribution will be quantified by MR imaging.
Newly diagnosed patients with type 2 diabetes (T2D) will be randomly allocated to once daily 25 mg empagliflozin (EMPA) or placebo for 24 weeks with a computer-generated random sequence and will be masked to the treatment assignment. Participants will visit the clinical research center at baseline, 12 weeks and 24 weeks for MRS and metabolic examinations, including blood sampling for hepato- and adipocytokines. Anthropometric parameters (body weight, waist circumference, total body fat, blood pressure) and glycemic control (HbA1C, fasting blood glucose, FBG) will be assessed at baseline and during monitoring visits every 4 weeks.
- Conditions
- Type 2 Diabetes, Non-alcoholic Fatty Liver Disease
- Being tested
- Empagliflozin, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
25 mg once daily
PlaceboDrug
Also called No Drug Therapy
once daily
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Empagliflozin, film-tablet, 25mg once daily Receives: Drug: Empagliflozin |
| Placebo | Placebo comparator | Placebo, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver fat content
Change in liver fat content between baseline and 24 weeks measured with magnetic resonance spectroscopy
Measured: from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Deutsche Diabetes Forschungsgesellschaft e.V.
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Michael Roden, MD, Principal investigator, Deutsches Diabetes Zentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637973
- Sponsor's protocol ID
- EmLiFa001
- Acronym
- EmLiFa
- Status last verified
- Jun 2023
- First submitted
- 16 Dec 2015
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Empagliflozin on Liver Fat Content, Energy Metabolism and Body Composition in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02637973
- Acronym / sponsor ID
- EmLiFa / EmLiFa001
- Conditions
- Type 2 Diabetes, Non-alcoholic Fatty Liver Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- The Deutsche Diabetes Forschungsgesellschaft e.V.University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Dec 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this multicentre, prospective, placebo-controlled, double-blind, randomized, 2-arm parallel, interventional pilot study HCL and intramyocellular lipids (IMCL) will be quantified with 1H magnetic resonance (MR) spectroscopy. Hepatic ATP and inorganic phosphate (Pi) concentrations will be assessed with 31P MR spectroscopy (1). Whole-body and hepatic insulin sensitivity and metabolic flexibility will be measured by combining hyperinsulinemic-euglycemic pancreatic clamp tests with isotopic dilution of 6,6-2H2 glucose and indirect calorimetry as shown (2). Abdominal fat distribution will be quantified by MR imaging.
Newly diagnosed patients with type 2 diabetes (T2D) will be randomly allocated to once daily 25 mg empagliflozin (EMPA) or placebo for 24 weeks with a computer-generated random sequence and will be masked to the treatment assignment. Participants will visit the clinical research center at baseline, 12 weeks and 24 weeks for MRS and metabolic examinations, including blood sampling for hepato- and adipocytokines. Anthropometric parameters (body weight, waist circumference, total body fat, blood pressure) and glycemic control (HbA1C, fasting blood glucose, FBG) will be assessed at baseline and during monitoring visits every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: EmpagliflozinEmpagliflozin, film-tablet, 25mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: Jardiance25 mg once daily | Drug | Empagliflozin |
| PlaceboAlso: No Drug Therapyonce daily | Drug | Placebo |
Primary outcome
Change in liver fat content
Time frame: from baseline to 24 weeks
Change in liver fat content between baseline and 24 weeks measured with magnetic resonance spectroscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Roden, MD principal investigator
Deutsches Diabetes Zentrum
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin in people with Type 2 Diabetes and Non-alcoholic Fatty Liver Disease, run by The Deutsche Diabetes Forschungsgesellschaft e.V. at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver fat content (time frame: from baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.