The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes (T2DM)

• Status: Terminated
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study hypothesis is that treatment with oral Testosterone according to the study regimen will improve glycemic control in T2DM Chinese males in Singapore as indicated by a reduction in HbA1c levels at study day 90.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore Clinical Research Institute
• Collaborators: Duke-NUS Graduate Medical School; Singapore General Hospital
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Subject is a Chinese male

• Subject is 45 to 75 years old

• Subject has T2DM with no change in type/dose of diabetic medication in the last 3 months

• Subject 's Haemoglobin level is between 13.5 - 18g/dl

• Subject's Haematocrit level is 40 - 54%

• Subject's Albumin level is between 3.5 - 5.0 g/dL

• Subject's Alanine transaminase (ALT) level is up to 36 U/L

• Subject's Aspartate transaminase (AST) level is < 41 U/L

• Subject's Alkaline phosphatase (ALP) level is < 130 U/L

• Subject's Creatinine (up to 60 years) level is between 0.57 - 1.36 mg/dL

• Subject's Creatinine (> 60 years) level is between 0.68 - 1.48 mg/dL

• Subject's Sodium (13 to 65 years) level is between 136 - 145 mmol/L

• Subject's Sodium ( > 65 years) level is between 132 - 146 mmol/L

• Subject's Potassium ( up to 59 years) level is between 3.3 - 5.1 mmol/L

• Subject's Potassium ( > 59 years) level is between 3.7 - 5.4 mmol/L

• Subject's PSA (Prostate Specific Antigen) level is ≤ 4ug/L

• Subject's Total Testosterone level is between 8.4 - 28.7 nmol/L

• Satisfactory haematological or biochemical functions tests only - these tests should be carried out during the screening period prior to enrolment. Patient with mild laboratory abnormalities can be included at the discretion by the site/co-investigator, and after approval by Co-ordinating Principal Investigator

• Written Informed Consent is obtained

• Subject is willing to comply with study procedures and is able to return to the clinic for scheduled visits

Exclusion Criteria:

• Subject's HbA1C level is > 9%.

• Subject is on insulin therapy

• Subject has history of recurrent hypoglycaemia

• Subject has history of malignancy (except skin cancer) during last 5 years

• Subject has received treatment for endocrinopathy within the last 3 months (except diabetes)

• Subject has history of adverse drug reaction to testosterone

• Subject has received testosterone replacement within the last 3 months

• Subject is currently receiving warfarin, steroids, cyclosporine or thyroxine

• Subject has history of Myocardial Infarction

• Subject has history of Angina

• Subject has heart failure which causes at least slight limitation of physical activity. Subject is comfortable at rest, but ordinary physical activity results in fatigue, palpitation or dyspnea

• Subject has history of Deep Vein Thrombosis or Stroke

• Subject has history of prostate cancer

• Subject has history of chronic kidney disease , Stage 3 or worse

• Subject has life expectancy of less than 1 year

• Subject has enlarged prostate per digital rectal examination

• Subject's International Prostate Symptom Score (IPSS) is greater than 20