Studying the effects of intramuscular testosterone supplementation compared with placebo on liver fat content in obese men with low testosterone levels and type 2 diabetes (T2DM) or prediabetes followed by a subsequent open label phase to investigate metabolic long term effects.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Trial duration

18 Jul 2019 → ongoing

Decision date (initial)

2024-03-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-509819-87-00

EudraCT number

2017-001611-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

to identify the effects of testosterone supplementation in
hypogonadal men suffering from type 2 diabetes or prediabetes on
intrahepatic fat content assessed as change from baseline to follow up

Conditions and MedDRA coding

hypogonadism, T2DM, prediabetes, overweight, obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. T2DM or prediabetes, male sex, HbA1c >=5,7% -9,0% or fasting glucose >=100mg/dl or postprandial glucose>= 140mg/dl, Age >=18 -75 years, BMI>=25kg/m², 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), Metformin >=8 weeks stable dose, SGLT2 inhibitors >=3 months stable dose, DPP4 inhibitors or GLP1 agonist >= 3 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.

Exclusion criteria 1

1. • 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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Change in liver fat content measured by magnetic resonance spectroscopy (MRS) from baseline to week 52

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Medicine III, Division of Endocrinology and Metabolism

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Medicine III, Division of Endocrinology and Metabolism

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications