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.Phase 4OTESTNCT01510847
The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes (T2DM)
A Phase 4 study testing Andriol Testocaps in people with 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., run by Singapore Clinical Research Institute at 12 sites in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- 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.
- What is being tested?
- Andriol Testocaps
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 12 sitesSingapore
- Study dates
- Oct 2011to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Singapore12 sites
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
About this study
Official 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.
Read the 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
- Being tested
- Andriol Testocaps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andriol TestocapsDrug
Oral, 40mg, Twice a day, 30days
| Study group | Role | What they receive |
|---|---|---|
| Oral Testosterone Therapy | Other | 90 day oral testosterone therapy Receives: Drug: Andriol Testocaps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 Day Study Period
Secondary outcomes (1)
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.
Measured: 90 day study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Unable to reach the target recruitment within timeline
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Clinical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Sam Lim, MBBS, Principal investigator, Singapore Clinical Research Institute Pte Lte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510847
- Sponsor's protocol ID
- OTEST/SCRI
- Other IDs
- DUKE-NUS-TIDR/2010/0001
- Acronym
- OTEST
- Status last verified
- Jan 2016
- First submitted
- 4 Jan 2012
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes: OTEST
- ClinicalTrials.gov ID
- NCT01510847
- Acronym / sponsor ID
- OTEST / OTEST/SCRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reach the target recruitment within timeline
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Singapore Clinical Research InstituteUniversity, hospital or other
- Collaborators
- Singapore General Hospital, Duke-NUS Graduate Medical School
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Testosterone Therapy | Other | Drug: Andriol Testocaps90 day oral testosterone therapy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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%
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andriol TestocapsOral, 40mg, Twice a day, 30days | Drug | Oral Testosterone Therapy |
Primary outcome
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.
1 secondary outcome
The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST
Time frame: 90 day study period
Results and safety
The study was stopped early (reason given: Unable to reach the target recruitment within timeline). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Lim, MBBS principal investigator
Singapore Clinical Research Institute Pte Lte
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Andriol Testocaps in people with 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., run by Singapore Clinical Research Institute at 12 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to reach the target recruitment within timeline). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST (time frame: 90 Day Study Period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.