ID

29184

Beskrivning

Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00937326

Länk

https://clinicaltrials.gov/show/NCT00937326

Nyckelord

Versioner (2)
  1. 2018-03-04 2018-03-04 -
  2. 2018-03-04 2018-03-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00937326

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT00937326

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subjects of any race and gender within the age range of 30 to 70 years.
Beskrivning

Racial group | Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0034510
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
2. all female subjects must be of non-child-bearing potential. for the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months, or at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or women who underwent tubal ligation. menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (fsh) 40 - 138 miu/ml and oestradiol < 20 pg/ml at entry, unless this information is available in the subject's medical record. in the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but fsh and/or oestradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the principal investigator following consultation with the sponsor and medical monitor
Beskrivning

Gender Childbearing Potential Absent | Amenorrhea Duration | Bilateral oophorectomy Postoperative Period | Hysterectomy | Tubal Ligation | Menopausal state | Follicle stimulating hormone measurement | Estradiol measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0278321
UMLS CUI [3,2]
C0032790
UMLS CUI [4]
C0020699
UMLS CUI [5]
C0520483
UMLS CUI [6]
C0025320
UMLS CUI [7]
C0202022
UMLS CUI [8]
C0337434
3. all male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug.
Beskrivning

Gender | Partner | Barrier Contraception Double | Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0682323
UMLS CUI [3,1]
C0004764
UMLS CUI [3,2]
C0205173
UMLS CUI [4]
C0036899
4. willingness to provide written informed consent to participate in the study
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
5. hba1c ≥ 7.5 and ≤ 10.5
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
6. fasting glucose ≥ 160 and ≤ 240 mg/dl
Beskrivning

Glucose measurement, fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0202045
7. body mass index (bmi) ≥ 25.0 kg/m^2 and ≤ 40.0 kg/m^2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
8. on stable metformin medication for at least 3 months (≥ 1.0 g/day) prior to screening
Beskrivning

Metformin Dose Stable U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
9. no prior history of hiv 1 or 2
Beskrivning

HIV-1 Absent | HIV-2 Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019704
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0019707
UMLS CUI [2,2]
C0332197
10. absence of disease markers for hepatitis b & c virus
Beskrivning

Hepatitis B Absent | Hepatitis C Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0332197
11. absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the screening; normal end organ function
Beskrivning

Disease Significant Absent | Laboratory test result abnormal Absent | Laboratory Procedures | Medical History | Physical Examination | End Organ function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0022885
UMLS CUI [4]
C0262926
UMLS CUI [5]
C0031809
UMLS CUI [6,1]
C0444930
UMLS CUI [6,2]
C0178784
UMLS CUI [6,3]
C0031843
12. have a normal 12-lead ecg or one with abnormality considered to be clinically insignificant
Beskrivning

12 lead ECG Normal | Electrocardiogram abnormal Without Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C2826293
13. have a normal chest x-ray (p. a. view) or one with abnormality considered to be clinically insignificant
Beskrivning

Chest X-ray normal | Chest X-ray abnormal Without Clinical Significance

Datatyp

boolean

Alias
UMLS CUI [1]
C0239026
UMLS CUI [2,1]
C0436503
UMLS CUI [2,2]
C0332288
UMLS CUI [2,3]
C2826293
14. comprehension of the nature and purpose of the study and compliance with the requirement of the entire protocol
Beskrivning

Comprehension Study Protocol | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any major illness in the past three months or any significant ongoing chronic medical illness not related to diabetes
Beskrivning

Illness Major | Chronic disease Independent of Diabetes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0011847
2. renal or liver impairment, defined as serum creatinine level of ≥ 1.4 mg/dl for females and ≥ 1.5 mg/dl for males, and greater than two times the upper limit of normal for liver enzymes, respectively.
Beskrivning

Renal Insufficiency | Hepatic impairment | Creatinine measurement, serum | Gender | Elevated liver enzymes

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0948807
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0235996
3. history of or current gastro-intestinal diseases influencing drug absorption, except for appendectomy
Beskrivning

Gastrointestinal Diseases Influence Drug absorption | Exception Appendectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003611
4. history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, and thc)
Beskrivning

Drug abuse | Benzodiazepines | Opioids | Amphetamines | Cocaine | Tetrahydrocannabinol

Datatyp

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0005064
UMLS CUI [3]
C0242402
UMLS CUI [4]
C0002667
UMLS CUI [5]
C0009170
UMLS CUI [6]
C0039663
5. history of alcoholism (more than two years), moderate drinkers (more than three drinks per day) or having consumed alcohol within 48 hrs prior to dosing [one drink is equal to one unit of alcohol (one glass wine, half pint beer, one measure of spirit)]
Beskrivning

Chronic Alcoholic Intoxication Duration | Moderate drinker | Alcohol consumption Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001973
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0337677
UMLS CUI [3,1]
C0001948
UMLS CUI [3,2]
C0332185
6. participation in any clinical trial within the past three months
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
7. history of difficulty in donating blood or accessibility of veins in left or right arm
Beskrivning

Blood Donation Difficult | Access Via arm vein Difficult

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332218
UMLS CUI [2,1]
C0444454
UMLS CUI [2,2]
C0442444
UMLS CUI [2,3]
C0332218
8. donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of test material
Beskrivning

Blood Donation Unit Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C1265611
9. use of any prescription drug therapy, with exception of any prescription medication administered at a stable dose for at least 6 weeks prior to screening, provided the medication is not contraindicated by the metformin label
Beskrivning

Pharmacotherapy | Exception Pharmaceutical Preparations Dose Stable Discontinued | Absence Medical contraindication Metformin

Datatyp

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [2,5]
C1444662
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C1301624
UMLS CUI [3,3]
C0025598
10. use of any alternate anti-diabetic therapy, except metformin, within three months of enrollment
Beskrivning

Antidiabetics Alternate | Exception Metformin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332270
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00937326

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Racial group | Gender | Age
Item
1. subjects of any race and gender within the age range of 30 to 70 years.
boolean
C0034510 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Gender Childbearing Potential Absent | Amenorrhea Duration | Bilateral oophorectomy Postoperative Period | Hysterectomy | Tubal Ligation | Menopausal state | Follicle stimulating hormone measurement | Estradiol measurement
Item
2. all female subjects must be of non-child-bearing potential. for the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months, or at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or women who underwent tubal ligation. menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (fsh) 40 - 138 miu/ml and oestradiol < 20 pg/ml at entry, unless this information is available in the subject's medical record. in the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but fsh and/or oestradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the principal investigator following consultation with the sponsor and medical monitor
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0278321 (UMLS CUI [3,1])
C0032790 (UMLS CUI [3,2])
C0020699 (UMLS CUI [4])
C0520483 (UMLS CUI [5])
C0025320 (UMLS CUI [6])
C0202022 (UMLS CUI [7])
C0337434 (UMLS CUI [8])
Gender | Partner | Barrier Contraception Double | Sexual Abstinence
Item
3. all male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug.
boolean
C0079399 (UMLS CUI [1])
C0682323 (UMLS CUI [2])
C0004764 (UMLS CUI [3,1])
C0205173 (UMLS CUI [3,2])
C0036899 (UMLS CUI [4])
Informed Consent
Item
4. willingness to provide written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Glucohemoglobin measurement
Item
5. hba1c ≥ 7.5 and ≤ 10.5
boolean
C0202054 (UMLS CUI [1])
Glucose measurement, fasting
Item
6. fasting glucose ≥ 160 and ≤ 240 mg/dl
boolean
C0202045 (UMLS CUI [1])
Body mass index
Item
7. body mass index (bmi) ≥ 25.0 kg/m^2 and ≤ 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Metformin Dose Stable U/day
Item
8. on stable metformin medication for at least 3 months (≥ 1.0 g/day) prior to screening
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
HIV-1 Absent | HIV-2 Absent
Item
9. no prior history of hiv 1 or 2
boolean
C0019704 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019707 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hepatitis B Absent | Hepatitis C Absent
Item
10. absence of disease markers for hepatitis b & c virus
boolean
C0019163 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Disease Significant Absent | Laboratory test result abnormal Absent | Laboratory Procedures | Medical History | Physical Examination | End Organ function
Item
11. absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the screening; normal end organ function
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0022885 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0444930 (UMLS CUI [6,1])
C0178784 (UMLS CUI [6,2])
C0031843 (UMLS CUI [6,3])
12 lead ECG Normal | Electrocardiogram abnormal Without Clinical Significance
Item
12. have a normal 12-lead ecg or one with abnormality considered to be clinically insignificant
boolean
C0430456 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0522055 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
Chest X-ray normal | Chest X-ray abnormal Without Clinical Significance
Item
13. have a normal chest x-ray (p. a. view) or one with abnormality considered to be clinically insignificant
boolean
C0239026 (UMLS CUI [1])
C0436503 (UMLS CUI [2,1])
C0332288 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
Comprehension Study Protocol | Protocol Compliance
Item
14. comprehension of the nature and purpose of the study and compliance with the requirement of the entire protocol
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Illness Major | Chronic disease Independent of Diabetes
Item
1. any major illness in the past three months or any significant ongoing chronic medical illness not related to diabetes
boolean
C0221423 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0011847 (UMLS CUI [2,3])
Renal Insufficiency | Hepatic impairment | Creatinine measurement, serum | Gender | Elevated liver enzymes
Item
2. renal or liver impairment, defined as serum creatinine level of ≥ 1.4 mg/dl for females and ≥ 1.5 mg/dl for males, and greater than two times the upper limit of normal for liver enzymes, respectively.
boolean
C1565489 (UMLS CUI [1])
C0948807 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0235996 (UMLS CUI [5])
Gastrointestinal Diseases Influence Drug absorption | Exception Appendectomy
Item
3. history of or current gastro-intestinal diseases influencing drug absorption, except for appendectomy
boolean
C0017178 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0003611 (UMLS CUI [2,2])
Drug abuse | Benzodiazepines | Opioids | Amphetamines | Cocaine | Tetrahydrocannabinol
Item
4. history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, and thc)
boolean
C0013146 (UMLS CUI [1])
C0005064 (UMLS CUI [2])
C0242402 (UMLS CUI [3])
C0002667 (UMLS CUI [4])
C0009170 (UMLS CUI [5])
C0039663 (UMLS CUI [6])
Chronic Alcoholic Intoxication Duration | Moderate drinker | Alcohol consumption Recent
Item
5. history of alcoholism (more than two years), moderate drinkers (more than three drinks per day) or having consumed alcohol within 48 hrs prior to dosing [one drink is equal to one unit of alcohol (one glass wine, half pint beer, one measure of spirit)]
boolean
C0001973 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0337677 (UMLS CUI [2])
C0001948 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Study Subject Participation Status
Item
6. participation in any clinical trial within the past three months
boolean
C2348568 (UMLS CUI [1])
Blood Donation Difficult | Access Via arm vein Difficult
Item
7. history of difficulty in donating blood or accessibility of veins in left or right arm
boolean
C0005794 (UMLS CUI [1,1])
C0332218 (UMLS CUI [1,2])
C0444454 (UMLS CUI [2,1])
C0442444 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Blood Donation Unit Quantity
Item
8. donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of test material
boolean
C0005794 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Pharmacotherapy | Exception Pharmaceutical Preparations Dose Stable Discontinued | Absence Medical contraindication Metformin
Item
9. use of any prescription drug therapy, with exception of any prescription medication administered at a stable dose for at least 6 weeks prior to screening, provided the medication is not contraindicated by the metformin label
boolean
C0013216 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C1444662 (UMLS CUI [2,5])
C0332197 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C0025598 (UMLS CUI [3,3])
Antidiabetics Alternate | Exception Metformin
Item
10. use of any alternate anti-diabetic therapy, except metformin, within three months of enrollment
boolean
C0935929 (UMLS CUI [1,1])
C0332270 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
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