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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Singapore Clinical Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Singapore General Hospital
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Professor Sam Lim MB BS FRACP PhD MBA, Singapore Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT01510847
First received: January 4, 2012
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
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.
Drug: Andriol Testocaps
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes: OTEST

Resource links provided by NLM:


Further study details as provided by Singapore Clinical Research Institute:

Primary Outcome Measures:
  • The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST [ Time Frame: 90 Day Study Period ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST [ Time Frame: 90 day study period ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Andriol Testocaps
    Oral, 40mg, Twice a day, 30days
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510847

Contacts
Contact: Sam Lim, MBBS 65 65088302 sam.lim@scri.edu.sg
Contact: Lee Kheng Hock, MBBS 65 63266360 lee.kheng.hock@sgh.com.sg

Locations
Singapore
Frontier Medical Associates (Ubi) Pte Ltd Recruiting
Singapore, Singapore, 400305
Contact: Tham Tat Yean, MBBS    65 67450875    thamty@frontierhealthcare.com.sg   
Contact: Ng Siau Peng, MBBS    65 67450875    ngsp@frontierhealthcare.com.sg   
Principal Investigator: Tham Tat Yean, MBBS         
Sub-Investigator: Ng Siau Peng, MBBS         
Sub-Investigator: Sim Kok Ping, MBBS         
Frontier Medical Associates (Woodlands) Pte Ltd Recruiting
Singapore, Singapore, 732899
Contact: Koh Thuan Wee, MBBS    65 63663631    kohtw@frontierhealthcare.com.sg   
Contact: Chan Miow-Swan, MBBS    65 63663631    chanms@frontierhealthcare.com.sg   
Sub-Investigator: Koh Thuan Wee, MBBS         
Sub-Investigator: Chan Miow-Swan, MBBS         
Frontier Medical Associates (AMK) Pte Ltd Recruiting
Singapore, Singapore, 560163
Contact: Anne Yeo Kwee Kee, MBBS    65 4532571    anne@frontierhealthcare.com.sg   
Contact: Aw Junjie, MBBS    65 4532571    awjj@frontierhealthcare.com.sg   
Sub-Investigator: Anne Yeo Kwee Kee, MBBS         
Sub-Investigator: Aw Junjie, MBBS         
Frontier Medical Associates (Buangkok Cresent) Pte Ltd Recruiting
Singapore, Singapore, 530982
Contact: Chong Chin Kwang, MBBS    6563152913    chongck@frontierhealthcare.com.sg   
Sub-Investigator: Chong Chin Kwang, MBBS         
Frontier Medical Associates (Yishun) Pte Ltd Recruiting
Singapore, Singapore, 760654
Contact: Goh Shu Huey, MBBS    65 67587536    gohsh@frontierhealthcare.com.sg   
Sub-Investigator: Goh Shu Huey, MBBS         
The Edinburgh Clinic Recruiting
Singapore, Singapore, 680306
Contact: Tan Tze Lee, MBBS    6567634500    drtantzelee@gmail.com   
Principal Investigator: Tan Tze Lee, MBBS         
Camry Medical Centre Recruiting
Singapore, Singapore, 310095
Contact: Teo Boon See, MBBS    6562580553    teobs@singnet.com.sg   
Contact: Tham Tuck Seng, MBBS    6562580553    drtstham@yahoo.com.sg   
Principal Investigator: Teo Boon See, MBBS         
Sub-Investigator: Tham Tuck Seng, MBBS         
Princeton Family Clinic Pte Ltd Recruiting
Singapore, Singapore, 670445
Contact: Kwong Kum Hong, MBBS    6567622278    khkwongdr@gmail.com   
Principal Investigator: Kwong Kum Hong, MBBS         
Bukit Batok Medical Clinic Recruiting
Singapore, Singapore, 650207
Contact: Kwek Thiam Soo, MBBS    6565603311    prismark69@yahoo.com   
Principal Investigator: Kwek Thiam Soo, MBBS         
EJ Tan Clinic & Surgery Recruiting
Singapore, Singapore, 600104
Contact: Loke Kam Weng, MBBS    6565606600    docloke8@singnet.com.sg   
Principal Investigator: Loke Kam Weng, MBBS         
Everhealth Family Clinic & Surgery Recruiting
Singapore, Singapore, 640762
Contact: Jonathan Pang Sze Kang, MBBS    6567933113    jpangsk@yahoo.com.sg   
Principal Investigator: Jonathan Pang Sze Kang, MBBS         
Everhealth Medical Centre Recruiting
Singapore, Singapore, 530540
Contact: Jonathan Pang Sze Kang, MBBS    6563850815    jpangsk@yahoo.com   
Principal Investigator: Jonathan Pang Sze Kang, MBBS         
Sponsors and Collaborators
Singapore Clinical Research Institute
Singapore General Hospital
Duke-NUS Graduate Medical School
Investigators
Principal Investigator: Sam Lim, MBBS Singapore Clinical Research Institute Pte Lte
  More Information

No publications provided

Responsible Party: Professor Sam Lim MB BS FRACP PhD MBA, Chief Operating Officer, Singapore Clinical Research Institute
ClinicalTrials.gov Identifier: NCT01510847     History of Changes
Other Study ID Numbers: OTEST/SCRI, DUKE-NUS-TIDR/2010/0001
Study First Received: January 4, 2012
Last Updated: January 12, 2012
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on July 22, 2014