ID

32863

Beskrivning

Safety, Tolerability and Activity Study of Multiple Doses of ISIS-SGLT2Rx in Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00836225

Länk

https://clinicaltrials.gov/show/NCT00836225

Nyckelord

Versioner (1)
  1. 2018-11-17 2018-11-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 november 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00836225

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00836225

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 to 65 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophorectomy or tubal ligation)
Beskrivning

Gender | Postmenopausal state | Female Sterilization | Hysterectomy | Ovariectomy | Tubal Ligation

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0020699
UMLS CUI [5]
C0029936
UMLS CUI [6]
C0520483
give written informed consent to participate in the study and availability for all study requirements
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
fasting plasma glucose </= the upper limit of the laboratory's reference range (uln)
Beskrivning

Plasma fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583513
hba1c </= uln
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
bmi < 30 kg/m²
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
agree to maintain steady hydration throughout study participation and agree not to fluid restrict
Beskrivning

Maintenance Hydration Steady | Fluid restriction Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024501
UMLS CUI [1,2]
C4520800
UMLS CUI [1,3]
C0205361
UMLS CUI [2,1]
C0204700
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant women, nursing mothers or women of childbearing potential
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
clinically significant abnormalities in medical history or physical examination
Beskrivning

Medical History Abnormality | Physical examination abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0747585
clinically significant abnormalities in laboratory examination (including alt > uln, ast > uln, bilirubin > uln, creatinine > uln, urine protein positive by urine dipstick, platelets < lower limit of normal and any other clinically significant laboratory findings)
Beskrivning

Laboratory test result abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin | Serum creatinine raised | Proteinuria Urine dipstick test | Decreased platelet count | Laboratory test finding Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0741494
UMLS CUI [5]
C0700225
UMLS CUI [6,1]
C0033687
UMLS CUI [6,2]
C0430370
UMLS CUI [7]
C0392386
UMLS CUI [8,1]
C0587081
UMLS CUI [8,2]
C2826293
estimated gfr < 60 ml/min per 1.73m²
Beskrivning

Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C3811844
history of clinically significant abnormalities in coagulation parameters
Beskrivning

Abnormal coagulation profile

Datatyp

boolean

Alias
UMLS CUI [1]
C0375576
positive test result for hiv, hepatitis b virus, and/or hepatitis c virus
Beskrivning

HIV Seropositivity | Hepatitis B virus test positive | Hepatitis C virus test positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C2748184
UMLS CUI [3]
C2748185
active infection requiring antiviral or antimicrobial therapy
Beskrivning

Communicable Disease Requirement Antiviral Therapy | Communicable Disease Requirement Antimicrobials

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0280274
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C1136254
subjects on chronic or acute prescription medication may be permitted after discussion with the isis medical monitor
Beskrivning

Prescribed medication chronic allowed | Prescribed medication allowed | Status post Discussion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239117
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0683607
UMLS CUI [2,1]
C2239117
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1283217
malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > 1 year)
Beskrivning

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Recurrence Absent Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0034897
UMLS CUI [4,3]
C0332197
UMLS CUI [4,4]
C0449238
any other concurrent condition which, in the opinion of the investigator, would preclude participation in this study or interfere with compliance
Beskrivning

Comorbidity Study Subject Participation Status Excluded | Comorbidity Interferes with Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
past and present history of alcohol or drug abuse (defined as > 3 units daily)
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to screening
Beskrivning

Investigational New Drugs | Biological Agents | Investigational Medical Device

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0005515
UMLS CUI [3]
C2346570
blood donation within three months of screening
Beskrivning

Blood Donation

Datatyp

boolean

Alias
UMLS CUI [1]
C0005794
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00836225

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 to 65 years
boolean
C0001779 (UMLS CUI [1])
Gender | Postmenopausal state | Female Sterilization | Hysterectomy | Ovariectomy | Tubal Ligation
Item
male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophorectomy or tubal ligation)
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
C0029936 (UMLS CUI [5])
C0520483 (UMLS CUI [6])
Informed Consent | Protocol Compliance
Item
give written informed consent to participate in the study and availability for all study requirements
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
fasting plasma glucose </= the upper limit of the laboratory's reference range (uln)
boolean
C0583513 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c </= uln
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi < 30 kg/m²
boolean
C1305855 (UMLS CUI [1])
Maintenance Hydration Steady | Fluid restriction Absent
Item
agree to maintain steady hydration throughout study participation and agree not to fluid restrict
boolean
C0024501 (UMLS CUI [1,1])
C4520800 (UMLS CUI [1,2])
C0205361 (UMLS CUI [1,3])
C0204700 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential
Item
pregnant women, nursing mothers or women of childbearing potential
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Medical History Abnormality | Physical examination abnormal
Item
clinically significant abnormalities in medical history or physical examination
boolean
C0262926 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0747585 (UMLS CUI [2])
Laboratory test result abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin | Serum creatinine raised | Proteinuria Urine dipstick test | Decreased platelet count | Laboratory test finding Clinical Significance
Item
clinically significant abnormalities in laboratory examination (including alt > uln, ast > uln, bilirubin > uln, creatinine > uln, urine protein positive by urine dipstick, platelets < lower limit of normal and any other clinically significant laboratory findings)
boolean
C0438215 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
C0033687 (UMLS CUI [6,1])
C0430370 (UMLS CUI [6,2])
C0392386 (UMLS CUI [7])
C0587081 (UMLS CUI [8,1])
C2826293 (UMLS CUI [8,2])
Estimated Glomerular Filtration Rate
Item
estimated gfr < 60 ml/min per 1.73m²
boolean
C3811844 (UMLS CUI [1])
Abnormal coagulation profile
Item
history of clinically significant abnormalities in coagulation parameters
boolean
C0375576 (UMLS CUI [1])
HIV Seropositivity | Hepatitis B virus test positive | Hepatitis C virus test positive
Item
positive test result for hiv, hepatitis b virus, and/or hepatitis c virus
boolean
C0019699 (UMLS CUI [1])
C2748184 (UMLS CUI [2])
C2748185 (UMLS CUI [3])
Communicable Disease Requirement Antiviral Therapy | Communicable Disease Requirement Antimicrobials
Item
active infection requiring antiviral or antimicrobial therapy
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0280274 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1136254 (UMLS CUI [2,3])
Prescribed medication chronic allowed | Prescribed medication allowed | Status post Discussion
Item
subjects on chronic or acute prescription medication may be permitted after discussion with the isis medical monitor
boolean
C2239117 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C2239117 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1283217 (UMLS CUI [3,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Recurrence Absent Duration
Item
malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > 1 year)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0034897 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0449238 (UMLS CUI [4,4])
Comorbidity Study Subject Participation Status Excluded | Comorbidity Interferes with Protocol Compliance
Item
any other concurrent condition which, in the opinion of the investigator, would preclude participation in this study or interfere with compliance
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Substance Use Disorders
Item
past and present history of alcohol or drug abuse (defined as > 3 units daily)
boolean
C0038586 (UMLS CUI [1])
Investigational New Drugs | Biological Agents | Investigational Medical Device
Item
undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to screening
boolean
C0013230 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Blood Donation
Item
blood donation within three months of screening
boolean
C0005794 (UMLS CUI [1])
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