{ "FullStudy":{ "Rank":218244, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510847", "OrgStudyIdInfo":{ "OrgStudyId":"OTEST/SCRI" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"DUKE-NUS-TIDR/2010/0001", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Singapore Clinical Research Institute PL/DUKE-NUS Singapore" } ] }, "Organization":{ "OrgFullName":"Singapore Clinical Research Institute", "OrgClass":"OTHER" }, "BriefTitle":"The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes (T2DM)", "OfficialTitle":"The Effect of 90-day Oral Testosterone Therapy in Chinese Males With Type 2 Diabetes: OTEST", "Acronym":"OTEST" }, "StatusModule":{ "StatusVerifiedDate":"January 2016", "OverallStatus":"Terminated", "WhyStopped":"Unable to reach the target recruitment within timeline", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 4, 2012", "StudyFirstSubmitQCDate":"January 12, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 18, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 5, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 6, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Singapore Clinical Research Institute", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Singapore General Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Duke-NUS Graduate Medical School", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"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.", "DetailedDescription":"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.\n\nSubjects 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.\n\nPrimary objective:\n\n- 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.\n\nSecondary objectives:\n\n- 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.\n\nAll subjects must satisfy ALL of the following criteria at study entry:\n\nSubject is a Chinese male\nSubject is 45 to 75 years old\nSubject has T2DM with no change in type/dose of diabetic medication in the last 3 months\nSubject's Haemoglobin level is between 13.5 - 18g/dl\nSubject's Haematocrit level is 40 - 54%\nSubject's Albumin level is between 3.5 - 5.0 g/dL\nSubject's Alanine transaminase (ALT) level is up to 36 U/L\nSubject's Aspartate transaminase (AST) level is < 41 U/L\nSubject's Alkaline phosphatase (ALP) level is < 130 U/L\nSubject's Creatinine(up to 60 years) level is between 0.57 - 1.36 mg/dL\nSubject's Creatinine(> 60 years) level is between 0.68 - 1.48 mg/dL\nSubject's Sodium(13 to 65 years) level is between 136 - 145 mmol/L\nSubject's Sodium(> 65 years) level is between 132 - 146 mmol/L\nSubject's Potassium (up to 59 years) level is between 3.3 - 5.1 mmol/L\nSubject's Potassium (> 59 years) level is between 3.7 - 5.4 mmol/L\nSubject's PSA (Prostate Specific Antigen) level is ≤ 4ug/L\nSubject's Total Testosterone level is between 8.4 - 28.7 nmol/L\nSatisfactory 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\nWritten Informed Consent is obtained\nSubject is willing to comply with study procedures and is able to return to the clinic for scheduled visits\n\nAll subjects must NOT have any of the following criteria at study entry:\n\nSubject's HbA1C level is > 9%.\nSubject is on insulin therapy\nSubject has history of recurrent hypoglycaemia\nSubject has history of malignancy (except skin cancer) during last 5 years\nSubject has received treatment for endocrinopathy within the last 3 months (except diabetes)\nSubject has history of adverse drug reaction to testosterone\nSubject has received testosterone replacement within the last 3 months\nSubject is currently receiving warfarin, steroids, cyclosporine or thyroxine\nSubject has history of Myocardial Infarction\nSubject has history of Angina\nSubject 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\nSubject has history of Deep Vein Thrombosis or Stroke\nSubject has history of prostate cancer\nSubject has history of chronic kidney disease , Stage 3 or worse\nSubject has life expectancy of less than 1 year\nSubject has enlarged prostate per digital rectal examination\nSubject's International Prostate Symptom Score (IPSS) is greater than 20\n\nBlood samples will be drawn during the study period:\n\n16 types of blood samples at Baseline, Month 1 and Month 3 Visits.\nHbA1c, Haemoglobin, Haematocrit, Albumin, ALT, AST, ALP,Creatinine,PSA, Total Testosterone, Total Cholesterol,HDL, LDL, Triglycerides, Sodium,Potassium" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "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." ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"19", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Oral Testosterone Therapy", "ArmGroupType":"Other", "ArmGroupDescription":"90 day oral testosterone therapy", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Andriol Testocaps" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Andriol Testocaps", "InterventionDescription":"Oral, 40mg, Twice a day, 30days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Oral Testosterone Therapy" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST", "PrimaryOutcomeDescription":"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.", "PrimaryOutcomeTimeFrame":"90 Day Study Period" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The Effect of 90-day Oral Testosterone Therapy in Chinese Males with Type 2 Diabetes (T2DM): OTeST", "SecondaryOutcomeDescription":"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.", "SecondaryOutcomeTimeFrame":"90 day study period" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubject is a Chinese male\nSubject is 45 to 75 years old\nSubject has T2DM with no change in type/dose of diabetic medication in the last 3 months\nSubject 's Haemoglobin level is between 13.5 - 18g/dl\nSubject's Haematocrit level is 40 - 54%\nSubject's Albumin level is between 3.5 - 5.0 g/dL\nSubject's Alanine transaminase (ALT) level is up to 36 U/L\nSubject's Aspartate transaminase (AST) level is < 41 U/L\nSubject's Alkaline phosphatase (ALP) level is < 130 U/L\nSubject's Creatinine (up to 60 years) level is between 0.57 - 1.36 mg/dL\nSubject's Creatinine (> 60 years) level is between 0.68 - 1.48 mg/dL\nSubject's Sodium (13 to 65 years) level is between 136 - 145 mmol/L\nSubject's Sodium ( > 65 years) level is between 132 - 146 mmol/L\nSubject's Potassium ( up to 59 years) level is between 3.3 - 5.1 mmol/L\nSubject's Potassium ( > 59 years) level is between 3.7 - 5.4 mmol/L\nSubject's PSA (Prostate Specific Antigen) level is ≤ 4ug/L\nSubject's Total Testosterone level is between 8.4 - 28.7 nmol/L\nSatisfactory 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\nWritten Informed Consent is obtained\nSubject is willing to comply with study procedures and is able to return to the clinic for scheduled visits\n\nExclusion Criteria:\n\nSubject's HbA1C level is > 9%.\nSubject is on insulin therapy\nSubject has history of recurrent hypoglycaemia\nSubject has history of malignancy (except skin cancer) during last 5 years\nSubject has received treatment for endocrinopathy within the last 3 months (except diabetes)\nSubject has history of adverse drug reaction to testosterone\nSubject has received testosterone replacement within the last 3 months\nSubject is currently receiving warfarin, steroids, cyclosporine or thyroxine\nSubject has history of Myocardial Infarction\nSubject has history of Angina\nSubject 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\nSubject has history of Deep Vein Thrombosis or Stroke\nSubject has history of prostate cancer\nSubject has history of chronic kidney disease , Stage 3 or worse\nSubject has life expectancy of less than 1 year\nSubject has enlarged prostate per digital rectal examination\nSubject's International Prostate Symptom Score (IPSS) is greater than 20", "HealthyVolunteers":"No", "Gender":"Male", "MinimumAge":"45 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Sam Lim, MBBS", "OverallOfficialAffiliation":"Singapore Clinical Research Institute Pte Lte", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Camry Medical Centre", "LocationCity":"Singapore", "LocationZip":"310095", "LocationCountry":"Singapore" },{ "LocationFacility":"Frontier Medical Associates (Ubi) Pte Ltd", "LocationCity":"Singapore", "LocationZip":"400305", "LocationCountry":"Singapore" },{ "LocationFacility":"Everhealth Medical Centre", "LocationCity":"Singapore", "LocationZip":"530540", "LocationCountry":"Singapore" },{ "LocationFacility":"Frontier Medical Associates (Buangkok Cresent) Pte Ltd", "LocationCity":"Singapore", "LocationZip":"530982", "LocationCountry":"Singapore" },{ "LocationFacility":"Frontier Medical Associates (AMK) Pte Ltd", "LocationCity":"Singapore", "LocationZip":"560163", "LocationCountry":"Singapore" },{ "LocationFacility":"EJ Tan Clinic & Surgery", "LocationCity":"Singapore", "LocationZip":"600104", "LocationCountry":"Singapore" },{ "LocationFacility":"Everhealth Family Clinic & Surgery", "LocationCity":"Singapore", "LocationZip":"640762", "LocationCountry":"Singapore" },{ "LocationFacility":"Bukit Batok Medical Clinic", "LocationCity":"Singapore", "LocationZip":"650207", "LocationCountry":"Singapore" },{ "LocationFacility":"Princeton Family Clinic Pte Ltd", "LocationCity":"Singapore", "LocationZip":"670445", "LocationCountry":"Singapore" },{ "LocationFacility":"The Edinburgh Clinic", "LocationCity":"Singapore", "LocationZip":"680306", "LocationCountry":"Singapore" },{ "LocationFacility":"Frontier Medical Associates (Woodlands) Pte Ltd", "LocationCity":"Singapore", "LocationZip":"732899", "LocationCountry":"Singapore" },{ "LocationFacility":"Frontier Medical Associates (Yishun) Pte Ltd", "LocationCity":"Singapore", "LocationZip":"760654", "LocationCountry":"Singapore" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"C000010792", "InterventionMeshTerm":"Testosterone undecanoate" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000728", "InterventionAncestorTerm":"Androgens" },{ "InterventionAncestorId":"D000006728", "InterventionAncestorTerm":"Hormones" },{ "InterventionAncestorId":"D000006730", "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M10334", "InterventionBrowseLeafName":"Methyltestosterone", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15092", "InterventionBrowseLeafName":"Testosterone", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M231009", "InterventionBrowseLeafName":"Testosterone undecanoate", "InterventionBrowseLeafAsFound":"Andriol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M231022", "InterventionBrowseLeafName":"Testosterone enanthate", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M243057", "InterventionBrowseLeafName":"Testosterone 17 beta-cypionate", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2640", "InterventionBrowseLeafName":"Androgens", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8371", "InterventionBrowseLeafName":"Hormone Antagonists", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5702", "ConditionBrowseLeafName":"Diabetes Mellitus, Type 2", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }