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    Summary
    EudraCT Number:2017-001611-37
    Sponsor's Protocol Code Number:T2F12017
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-11-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2017-001611-37
    A.3Full title of the trial
    A 52 week prospective randomized controlled study to investigate the effect of intramuscular testosterone undecanoate supplementation vs placebo on intrahepatic fat content in obese men with uncontrolled type 2 diabetes (T2DM) suffering from hypogonadism with a subsequent 108 week open label phase to investigate long term effects on lipid distribution and cardiometabolic parameters in all participating men.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Studying the effects of intramuscular testosterone supplementation compared with placebo on liver fat content in obese men with low testosterone levels and uncontrolled type 2 diabetes (T2DM) followed by a subsequent open label phase to investigate metabolic long term effects.
    A.3.2Name or abbreviated title of the trial where available
    Test2Func
    A.4.1Sponsor's protocol code numberT2F12017
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical University Vienna, Gender Medicine Unit, Div. of Endocrinology, Dep of Medicine III
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical University of Vienna
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University Vienna, Gender Medicine Unit, Div. of Endocrinology, Dep of Medicine III
    B.5.2Functional name of contact pointMedical University Vienna
    B.5.3 Address:
    B.5.3.1Street AddressWähringergürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+431404002228
    B.5.6E-mailjuergen.harreiter@meduniwien.ac.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Nebido
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTestosterone undecanoate
    D.3.2Product code G03BA03
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTestosterone undecanoate
    D.3.9.1CAS number 5949-44-0
    D.3.9.3Other descriptive nameTESTOSTERONE UNDECANOATE
    D.3.9.4EV Substance CodeSUB04744MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    hypogonadism, T2DM, obesity
    E.1.1.1Medical condition in easily understood language
    low testosterone levels, high blood glucose levels, severe overweight
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • to identify the effects of testosterone supplementation in hypogonadal men suffering from type 2 diabetes on intrahepatic fat content assessed as change from baseline to follow up
    E.2.2Secondary objectives of the trial
    To identify the effects of testosterone supplementation in hypogonadal men suffering from type 2 diabetes on myocardial and pancreatic fat content, subcutaneous and visceral fat accumulation assessed as change from baseline to follow up, as well as on weight and body composition, glycaemic control measured as changes from baseline on HbA1c and changes from baseline on insulin secretion and sensitivity assessd by oGTT, cardiometabolic parameters (e.g. HDL,LDL, Lpa, chol, trig, usCRP, BNP, PAI1, GDF15, TNF a, IL 6, MCP1, Leptin, Adiponectin and others), RRsys, RRdia, heart rate at rest, on 24hour blood pressure measurement, on continuous glucose measurement, on carotid intima-media-thickness, on systolic and diastolic function of the heart assessed by MR techniques, on quality of life, on sexual function, on physical activity and eating behavior, on lipid distribution, on kidney function, on cardiac perfusion and cardiac performance, on bone function.






    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • T2DM
    • male sex
    • HbA1c >=7,5% -10%
    • Age >=18 -75 years
    • BMI>=30kg/m²
    • Hypogonadism assessed by laboratory testing (testosterone: two measurements below lower limit of normal total testosterone levels (< 3,5ng/ml (=12.1nmol/l) according to EAU guideline)
    • Metformin >=8 weeks stable dose, SGLT2 inhibitors >=6 months stable dose, DPP4 inhibitors or GLP1 agonist >= 6 months stable dose, and long acting insulin (basal insulin) >=8 weeks stable dose
    • able and willing to not change diet and physical activity during enrolement in study
    • consent and able to give informed consent.
    E.4Principal exclusion criteria
    • Current testosterone treatment or testosterone replacement within the last 12 month
    • Serum creatinine>1,5mg/dl
    • Liver enzymes above 3 fold normal range
    • PSA>4.0µg/l
    • Hematocrit>50%
    • Known intolerance to testosterone undecanoate or any of its ingredients
    • Myocardial infarction within the last 12month
    • Stroke within the last 12 month
    • Untreated congestive heart disease
    • malignancy within the last 5 years before randomization
    • Prostate cancer or any suspicion thereof
    • Breast cancer
    • Liver tumor/cancer
    • Epilepsy
    • Migraine
    • Presence of any absolute or relative contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.
    • patients on antidiabetic medication like Sulfonylurea or Glitazones.
    • Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
    • Known autoimmune disease or chronic inflammatory condition
    • Other 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
    • Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
    • History of bariatric surgery
    • Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
    • Subjects receiving antihypertensive medication and/or thyroid hormones, the dose(s) of which have not been stable for at least 6 weeks prior to baseline
    • Current treatment with systemic steroids at time of informed consent. (Treatment with local and inhaled steroids is allowed)
    • Donation of blood (> 400 mL) during the previous 3 months prior to the screening visit or during the duration of the study
    • Participation in another trial with an investigational drug within 30 days prior to informed consent.
    • Any subject who is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol.
    • Contraindication for intramuscular injection (e.g patient receiving anticoagulants on a regular basis such as NOAKs or VKAs, or DAPT).
    • COPD Gold IV or recurrent acute or allergic asthma (for MPI)
    E.5 End points
    E.5.1Primary end point(s)
    • Change in liver fat content measured by magnetic resonance spectroscopy (MRS) from baseline to week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline to week 52
    E.5.2Secondary end point(s)
    • Change in body fat, liver volume, visceral adipose tissue, subcutaneous adipose tissue, total adipose tissue and total lean tissue, myocardial and pancreatic fat and ventricular function from baseline to week 52
    • change in systolic and diastolic blood pressure from baseline to week 52
    • change in body weight from baseline to week 52
    • The change in waist, hip and neck circumference from baseline after 52 weeks of treatment.
    • The change in insulin sensitivity and Insulin secretion assessed by oGTT from baseline
    • change in HbA1c from baseline to week 52
    • The change in lipid profile from baseline and free fatty acids in the OGTT
    • The occurrence of confirmed symptomatic hypoglycaemic events.
    • Changes in quality of live, sexual function and diabetes management satisfaction from baseline to week 52Change in cardiac parameters and cardiometabolic parameters from baseline to week 52
    • Change in kidney function and relevant parameters (GFR, Alb/Krea ratio) from baseline to week 52

    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline to week 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    subject's will be treated in the diabetes outpatient's clinic of the
    Medical University of Vienna according to standard guidelines after the
    end of the study.
    optional prolongation for study population ín the open label phase is possible after finishing the RCT.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
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