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. Clinical Trial
— OTESTOfficial title:
The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes: OTEST
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.
| Status | Terminated |
| Enrollment | 19 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 45 Years to 75 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Singapore | Bukit Batok Medical Clinic | Singapore | |
| Singapore | Camry Medical Centre | Singapore | |
| Singapore | EJ Tan Clinic & Surgery | Singapore | |
| Singapore | Everhealth Family Clinic & Surgery | Singapore | |
| Singapore | Everhealth Medical Centre | Singapore | |
| Singapore | Frontier Medical Associates (AMK) Pte Ltd | Singapore | |
| Singapore | Frontier Medical Associates (Buangkok Cresent) Pte Ltd | Singapore | |
| Singapore | Frontier Medical Associates (Ubi) Pte Ltd | Singapore | |
| Singapore | Frontier Medical Associates (Woodlands) Pte Ltd | Singapore | |
| Singapore | Frontier Medical Associates (Yishun) Pte Ltd | Singapore | |
| Singapore | Princeton Family Clinic Pte Ltd | Singapore | |
| Singapore | The Edinburgh Clinic | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| Singapore Clinical Research Institute | Duke-NUS Graduate Medical School, Singapore General Hospital |
Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST | The primary aim is to assess the effect of oral Testosterone Supplementation on percent change in HbA1c in Type 2 Diabetes Mellitus Chinese males in Singapore over a 90-day study period. | 90 Day Study Period | Yes |
| Secondary | The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST | The secondary aim is to assess the effects of site, eugonadism and hypogonadism, and the prognostic relevance of baseline levels of HbA1c, total testosterone, PSA, IPSS, haemoglobin and haematocrit on 90-day change and percent change from baseline in HbA1c under the study Testosterone Supplementation regimen. | 90 day study period | Yes |