TESTOSTERONE UNDECANOATE for Hypogonadism | Type 2 diabetes mellitus | Prediabetes | Overweight | Obesity

Inclusion criteria

• {"criterion_text":"- T2DM or prediabetes\n- male sex\n- HbA1c >=5,7% -9,0% or fasting glucose >=100mg/dl or postprandial glucose>= 140mg/dl\n- Age >=18 -75 years\n- BMI>=25kg/m²\n- Hypogonadism assessed by laboratory testing (testosterone: two measurements below lower limit of normal total testosterone levels (< 4,04ng/ml (=14nmol/l) according to guideline Wittert et al. Lancet Diabetes Endocrinol. 2021)\n- Metformin >=8 weeks stable dose\n- SGLT2 inhibitors >=3 months stable dose\n- DPP4 inhibitors or GLP1 agonist >= 3 months stable dose\n- and long acting insulin (basal insulin) >=8 weeks stable dose\n- able and willing to not change diet and physical activity during enrolement in study\n- consent and able to give informed consent."}

Exclusion criteria

• {"criterion_text":"- Current testosterone treatment or testosterone replacement within the last 12 month\n- Serum creatinine>1,5mg/dl\n- Liver enzymes above 3 fold normal range\n- PSA>4.0µg/l\n- Hematocrit>50%\n- Known intolerance to testosterone undecanoate or any of its ingredients\n- Myocardial infarction within the last 12month\n- Stroke within the last 12 month\n- Untreated congestive heart disease\n- malignancy within the last 5 years before randomization\n- Prostate cancer or any suspicion thereof\n- Breast cancer\n- Liver tumor/cancer\n- Epilepsy\n- Migraine\n- 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.\n- patients on antidiabetic medication like Sulfonylurea or Glitazones.\n- Any other clinical condition that would jeopardize patients safety while participating in this clinical trial\n- Known autoimmune disease or chronic inflammatory condition\n- 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\n- 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\n- History of bariatric surgery\n- 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\n- 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\n- Current treatment with systemic steroids at time of informed consent.(Treatment with local and inhaled steroids is allowed)\n- Donation of blood (> 400 mL) during the previous 3 months prior to the screening visit or during the duration of the study\n- Participation in another trial with an investigational drug within 30 days prior to informed consent.\n- 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.\n- Contraindication for intramuscular injection (e.g patient receiving anticoagulants on a regular basis such as NOAKs or VKAs, or DAPT).\n- COPD Gold IV or recurrent acute or allergic asthma (for MPI)"}

Primary endpoints

• {"endpoint_text":"- • Change in liver fat content measured by magnetic resonance spectroscopy (MRS) from baseline to week 52","definition_or_measurement_approach":"Measured by magnetic resonance spectroscopy (MRS); assessed as change from baseline to week 52 (change from baseline to follow up)."}

Austria

Earliest CTIS Part Ii Submission Date

14-01-2024

Latest Decision Or Authorization Date

18-03-2024

Processing Time Days

64

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria