Status:
TERMINATED
The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes (T2DM)
Lead Sponsor:
Singapore Clinical Research Institute
Collaborating Sponsors:
Singapore General Hospital
Duke-NUS Graduate Medical School
Conditions:
Assess the Effects of a the 90-day Oral TS Study Regimen on PSA, IPSS, Haemoglobin and Haematocrit, and to Assess Adverse and Serious Adverse Events.
Eligibility:
MALE
45-75 years
Phase:
PHASE4
Brief 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 level...
Detailed Description
This is a single arm open label clinical study in Chinese men of 45 to 75 years of age with Type 2 Diabetes. Subjects will be recruited from participating family medicine clinics with the FMRN and fol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01510847
Start Date
October 1 2011
End Date
September 1 2012
Last Update
January 6 2016
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Camry Medical Centre
Singapore, Singapore, Singapore, 310095
2
Frontier Medical Associates (Ubi) Pte Ltd
Singapore, Singapore, Singapore, 400305
3
Everhealth Medical Centre
Singapore, Singapore, Singapore, 530540
4
Frontier Medical Associates (Buangkok Cresent) Pte Ltd
Singapore, Singapore, Singapore, 530982