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    EudraCT Number:2011-000942-39
    Sponsor's Protocol Code Number:NL34476.068.11
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-04-04
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-000942-39
    A.3Full title of the trial
    Effects of thyroid hormone treatment on mitochondrial function, ectopic fat accumulation, insulin sensitivity and brown adipose tissue in type 2 diabetes mellitus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of thyroid hormone treatment on energyproduction, fat storage and sugar disease.
    A.3.2Name or abbreviated title of the trial where available
    Thyroid and type 2 diabetes
    A.4.1Sponsor's protocol code numberNL34476.068.11
    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 SponsorCTMM, the Center for Translational Molecular Medicine
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCTMM
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTMM
    B.5.2Functional name of contact pointErna Erdsieck-Ernste
    B.5.3 Address:
    B.5.3.1Street AddressHigh Tech Campus 12a (HTC) Room 133
    B.5.3.2Town/ cityEindhoven
    B.5.3.3Post code5656AG
    B.5.4Telephone number+3140277 43 95
    B.5.5Fax number+314025 15 455
    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. name Euthyrox
    D. of the Marketing Authorisation holderMerck BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namelevothyroxine sodium
    D.3.2Product code RVG 09009
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 55-03-8
    D.3.9.2Current sponsor codeMERCK
    D.3.9.3Other descriptive namethyroxine
    D.3.9.4EV Substance CodeSUB08495MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This trial includes overweight patients with both hypothyroidism and type 2 diabetes.
    E.1.1.1Medical condition in easily understood language
    This study includes patients with Thyroid dysfunction, overweight and sugar disease.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10021114
    E.1.2Term Hypothyroidism
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to investigate whether thyroid hormone replacement therapy will improve
    insulin resistance and lower ectopic fat accumulation in the muscle, liver and heart. Furthermore, we would like to examine whether thyroid hormone replacement therapy enhances mitochondrial function via the process of mitochondrial uncoupling and changes the activity of brown adipose tissue.
    E.2.2Secondary objectives of the trial
    A secondary aim of this research project is whether thyroid hormone replacement therapy decreases
    mitochondrial membrane potential and lowers the production of reactive oxygen species.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or postmenopausal females
    - Age 40-65 years
    - Body mass index (BMI) < 40 and > 27 kg/m2
    - Stable dietary habits (no weight loss/gain >3 kg in the last 6 months)
    - Stable physical activity levels for at least six months
    - Newly diagnosed hypothyroid, non-insulin dependent type 2 diabetic patients having TSH values higher then > 4.0 mU/l and lowered concentrations of free T4 < 8.0 pmol/l.
    - Type 2 diabetic patients using sulphonylurea and or metformin therapy for at least six months with a constant dose for at least two months.
    - Hypothyroid diabetic patients due to Hashimoto disease (TPO > 100 IE/ml; Tg > 344 IE/ml), should have no auto-antibodies against glutamic acid decarboxylase (GAD), IA-2 and insulin to exclude type 2 polyglandular autoimmune syndrome (PGAII) (to exclude type 1 diabetes).
    - Type 2 diabetic patients should have a HbA1c level < 8.0%
    - Type 2 diabetic patients will be included when having no diabetes-related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy.
    E.4Principal exclusion criteria
    - Unstable body weight
    - Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
    - Medical history including active cardiovascular disease, i.e. history of coronary artery disease (i.e. history of angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting) or cardiac arrhythmias.
    - Liver disease or liver dysfunction (ALT>2.5 x increased)
    - Impaired renal function (kreatinine> 120 umol/L)
    - Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg
    - Hb <7.4 mmol/l (12 g/dl) in women, and <8.1 mmol/l (13 g/dl) in men
    - Abuse of drugs and/or alcohol
    - Contraindications for MRI scanning (please see appendix III: MRI contraindication questionnaire)
    - Patients with history of thyroid cancer
    - Patients using α and/or β blockers
    - Severe diabetes which requires application of insulin or patients with diabetes-related complications
    - History of psychiatric disease
    - Diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy.
    - Use of medications known to interfere with glucose homeostasis (i.e. corticosteroids, thiazolidendiones)
    - Hypothyroid diabetic patients due to Hashimoto disease with positive test values for auto-antibodies against GAD, IA-2 and insulin to exclude type 1 diabetes.
    - Use of anticoagulantia, other than platelet aggregation inhibitors.
    - Patients that have donated blood in the past 6 months
    E.5 End points
    E.5.1Primary end point(s)
    The primairy endpoints are changes in insulin sensitivity, lipid accumulation and mitochondrial function.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline (before starting the medication) and after 3 months of treatment.
    E.5.2Secondary end point(s)
    The secundairy endpoints are changes in activity of brown adipose tissue mitochondrial membrane potential production of radical oxygen species.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline (before starting the medication) and after 3 months of treatment.
    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 Yes
    E.6.13.1Other scope of the trial description
    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. 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    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 Yes
    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
    The end of the trial is planned to be at the 31 december of 2013. A extension for the study will be requested by the Medical Ethical Commission when the study is not finalized by then.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 17
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 17
    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)
    Thyroid hormone replacement therapy will be carefully monitored, evaluated and documented during the study period. This documentation will be provided to the doctor responsible for further treatment of the patients.
    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 Decision2011-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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