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

January 5, 2016 updated by: Singapore Clinical Research Institute

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.

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Oral Testosterone Therapy
90 day oral testosterone therapy
Oral, 40mg, Twice a day, 30days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST
Time Frame: 90 Day Study Period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST
Time Frame: 90 day study period
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sam Lim, MBBS, Singapore Clinical Research Institute Pte Lte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 12, 2012

First Posted (Estimate)

January 18, 2012

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • OTEST/SCRI
  • DUKE-NUS-TIDR/2010/0001 (Other Identifier: Singapore Clinical Research Institute PL/DUKE-NUS Singapore)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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