Effects of tesstosterone( male hormone) on glucose control and cardiovascular risk factors in men with type 2 diabetes

• Conditions: HypogonadismType 2 DiabetesCardiovascular risk; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2011-006114-14-GB
• Lead Sponsor: Research and Development department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-02
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Men with age >18 years
2.Type 2 Diabetes mellitus
3.HbA1C >7% <9.5%
4.Confirmed hypogonadism (early morning [0800-1000 h] total testosterone [TT] =12 nmol/L or calculated free testosterone =255 pmol/L on two occasions =1 week apart), with at least two symptoms of hypogonadism
5.Must be naïve to androgen replacement therapy
6.If on replacement therapy for the hypopituitarism or multiple endocrine deficiencies, the subject must be on stable doses of thyroid hormone and adrenal replacement hormones for at least 14 days prior to the enrolment.
7.No contraindication to the use of the study product – testosterone undecanoate
8.Patients understands the study protocol and voluntarily agrees to participate by providing written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Inability to give informed consent
2.Polycythaemia/ Haematocrit of >0.52
3.Abnormal prostrate digital rectal examination( palpable nodule/s) or severe prostratism or elevated PSA
4.History of prostrate cancer or breast cancer
5.Patient is enrolled in another experimental trial which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial
6.Patients with significant intercurrent disease like severe heart failure, kidney disease on dialysis, psychiatric illness or any other co-morbidities making them unable to attend the scheduled visits of the trial
7.History of alcohol abuse or any drug abuse in the past 2 years
8.Current use of antiandrogens, glucocorticoids ( except where used as replacement therapy), long acting opioid analgaesics( eg., methadone, buprenorphine), oestrogens, CYP3A4 inducers( eg., barbiturates) CYP3A4 inhibitors (eg., HIV antivirals, amiodarone, ketaconazole, ciprofloxacin, azithromycin etc)
9. Men seeking to father a child and have not yet completed the family.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified