The Effect of 90-day Oral Testosterone Therapy in Chinese... | NCT01510847

ID	Type	Description	Link
DUKE-NUS-TIDR/2010/0001	Other Identifier	Singapore Clinical Research Institute PL/DUKE-NUS Singapore

Status Module

Name	Class
Singapore General Hospital	OTHER
Duke-NUS Graduate Medical School	OTHER

Description Module

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 followed for 90-days. All subjects will continue on pre-study treatment regimens and medications as clinically indicated throughout the 90-day study period. Missed doses of study drug can be made up within the same day. With the exceptions of study drug and diabetic medications, changes in other medications will be permitted. The primary aim is to assess the effects of oral Testosterone on change in HbA1c levels in the Chinese males with a diagnosis of T2DM over a 90-day study period.

Subjects enrolled in the study will take two 40mg capsules of oral testosterone in the morning and two 40mg capsules in the evening with meals on both occasions on each day. This daily dosage is consistent with the recommended dosage for subjects being treated for hypogonadism.

Primary objective:

- The primary aim is to assess the effect of oral Testosterone on percent change in HbA1c in T2DM Chinese males in Singapore over a 90-day study period.

Secondary objectives:

- 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 regimen.

All subjects must satisfy ALL of the following criteria at study entry:

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

All subjects must NOT have any of the following criteria at study entry:

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

Blood samples will be drawn during the study period:

16 types of blood samples at Baseline, Month 1 and Month 3 Visits.
HbA1c, Haemoglobin, Haematocrit, Albumin, ALT, AST, ALP,Creatinine,PSA, Total Testosterone, Total Cholesterol,HDL, LDL, Triglycerides, Sodium,Potassium

Label	Type	Description	Intervention Names
Oral Testosterone Therapy	Other	90 day oral testosterone therapy	Drug: Andriol Testocaps

Name	Type	Description	Arm Group Labels	Other Names
Andriol Testocaps	Drug	Oral, 40mg, Twice a day, 30days	Oral Testosterone Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility 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

Facility	Status	City	State	ZIP	Country	Contacts
Camry Medical Centre		Singapore	Singapore	310095	Singapore
Frontier Medical Associates (Ubi) Pte Ltd