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

This study has been terminated.
(Unable to reach the target recruitment within timeline)
Sponsor:
Collaborators:
Singapore General Hospital
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Singapore Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT01510847
First received: January 4, 2012
Last updated: January 5, 2016
Last verified: January 2016
  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.


Enrollment: 19
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Oral Testosterone Therapy
90 day oral testosterone therapy
Drug: Andriol Testocaps
Oral, 40mg, Twice a day, 30days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
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

Locations
Singapore
Camry Medical Centre
Singapore, Singapore, 310095
Frontier Medical Associates (Ubi) Pte Ltd
Singapore, Singapore, 400305
Everhealth Medical Centre
Singapore, Singapore, 530540
Frontier Medical Associates (Buangkok Cresent) Pte Ltd
Singapore, Singapore, 530982
Frontier Medical Associates (AMK) Pte Ltd
Singapore, Singapore, 560163
EJ Tan Clinic & Surgery
Singapore, Singapore, 600104
Everhealth Family Clinic & Surgery
Singapore, Singapore, 640762
Bukit Batok Medical Clinic
Singapore, Singapore, 650207
Princeton Family Clinic Pte Ltd
Singapore, Singapore, 670445
The Edinburgh Clinic
Singapore, Singapore, 680306
Frontier Medical Associates (Woodlands) Pte Ltd
Singapore, Singapore, 732899
Frontier Medical Associates (Yishun) Pte Ltd
Singapore, Singapore, 760654
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

Responsible Party: 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 5, 2016
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents

ClinicalTrials.gov processed this record on September 30, 2016