ID

29250

Beschrijving

A Trial to Assess the Effect of Liraglutide on Blood Triglyceride (Fat) Levels After a Meal in Type 2 Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT00993304

Link

https://clinicaltrials.gov/show/NCT00993304

Trefwoorden

Versies (1)
  1. 12-03-18 12-03-18 -
Houder van rechten

See clinicaltrials.gov

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12 maart 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT00993304

Engels

Eligibility Diabetes NCT00993304

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00993304
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 diabetes mellitus (diet and exercise treated, or treated with specific oral antidiabetics (metformin, sulfonylureas and glinides) mono- or combination therapy) diagnosed at least 3 months previously
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length | Diet therapy | Exercise | Antidiabetics Oral | Metformin | Sulfonylurea | Glinides | Combined Modality Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [5]
C0025598
UMLS CUI [6]
C0038766
UMLS CUI [7]
C3537178
UMLS CUI [8]
C0009429
bmi between 18.5 and 40 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
hba1c between 6.5 and 10.0% both inclusive
Beschrijving

Glucohemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to trial products or related products
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
previous participation in this trial (randomised). re-screening of screening failures is allowed only once
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptives are defined as combination oral contraceptives (oc), hormonal intra uterine devices (iuds), implants and injectables; for germany, a condom for the male partner must be used in combination with oc, iud, implant or injectables for the duration of the trial and for 30 days following the last dose of trial medication) if not sterile or post-menopausal
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptives, Oral | Intrauterine Devices Hormonal | Contraceptive implant | Injectable contraception | Condoms, Male | Exception Infertility | Exception Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C0009905
UMLS CUI [6,1]
C0021900
UMLS CUI [6,2]
C0458083
UMLS CUI [7]
C1657106
UMLS CUI [8]
C1262153
UMLS CUI [9]
C0009653
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0021359
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0232970
the receipt of any investigational drug within 3 months prior to this trial
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
previous insulin treatment (short-term insulin treatment of up to 7 days are exempted if this has occurred no later than 3 months prior to screening).
Beschrijving

Insulin regime | Insulin regime short-term allowed

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder (except type 2 diabetes)
Beschrijving

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Disease Clinical Significance | Exception Non-Insulin-Dependent Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C2826293
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0011860
clinically significant active cardiovascular disease including history of myocardial infarction (heart attack) within the past 6 months and/or heart failure at the discretion of the investigator.
Beschrijving

Cardiovascular Disease | Myocardial Infarction | Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018801
history of alcoholism or drug abuse during the last 12 months
Beschrijving

Alcoholic Intoxication, Chronic | Drug abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013146
blood donation within the last 3 months. plasma donation within the last month.
Beschrijving

Blood Donation | Plasma Donation

Datatype

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0680854
additional exclusion criteria for germany: male subjects who are sexually active and have partners who are or could be pregnant, not using a barrier method of contraception (e.g. condom) for the duration of the trial and for 30 days following the last dose of trial medication
Beschrijving

Gender Sexually active Contraceptive methods Absent | Condoms, Male | Gender Partner in relationship Pregnancy | Gender Partner in relationship Childbearing Potential

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C0332197
UMLS CUI [2]
C0009653
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0032961
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C3831118
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Similar models

Eligibility Diabetes NCT00993304

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00993304
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length | Diet therapy | Exercise | Antidiabetics Oral | Metformin | Sulfonylurea | Glinides | Combined Modality Therapy
Item
subjects with type 2 diabetes mellitus (diet and exercise treated, or treated with specific oral antidiabetics (metformin, sulfonylureas and glinides) mono- or combination therapy) diagnosed at least 3 months previously
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0025598 (UMLS CUI [5])
C0038766 (UMLS CUI [6])
C3537178 (UMLS CUI [7])
C0009429 (UMLS CUI [8])
Body mass index
Item
bmi between 18.5 and 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c between 6.5 and 10.0% both inclusive
boolean
C0202054 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Study Subject Participation Status
Item
previous participation in this trial (randomised). re-screening of screening failures is allowed only once
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptives, Oral | Intrauterine Devices Hormonal | Contraceptive implant | Injectable contraception | Condoms, Male | Exception Infertility | Exception Postmenopausal state
Item
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptives are defined as combination oral contraceptives (oc), hormonal intra uterine devices (iuds), implants and injectables; for germany, a condom for the male partner must be used in combination with oc, iud, implant or injectables for the duration of the trial and for 30 days following the last dose of trial medication) if not sterile or post-menopausal
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0009905 (UMLS CUI [5])
C0021900 (UMLS CUI [6,1])
C0458083 (UMLS CUI [6,2])
C1657106 (UMLS CUI [7])
C1262153 (UMLS CUI [8])
C0009653 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0021359 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0232970 (UMLS CUI [11,2])
Investigational New Drugs
Item
the receipt of any investigational drug within 3 months prior to this trial
boolean
C0013230 (UMLS CUI [1])
Insulin regime | Insulin regime short-term allowed
Item
previous insulin treatment (short-term insulin treatment of up to 7 days are exempted if this has occurred no later than 3 months prior to screening).
boolean
C0557978 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Disease Clinical Significance | Exception Non-Insulin-Dependent Diabetes Mellitus
Item
cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder (except type 2 diabetes)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0011860 (UMLS CUI [5,2])
Cardiovascular Disease | Myocardial Infarction | Heart failure
Item
clinically significant active cardiovascular disease including history of myocardial infarction (heart attack) within the past 6 months and/or heart failure at the discretion of the investigator.
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
Alcoholic Intoxication, Chronic | Drug abuse
Item
history of alcoholism or drug abuse during the last 12 months
boolean
C0001973 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Blood Donation | Plasma Donation
Item
blood donation within the last 3 months. plasma donation within the last month.
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
Gender Sexually active Contraceptive methods Absent | Condoms, Male | Gender Partner in relationship Pregnancy | Gender Partner in relationship Childbearing Potential
Item
additional exclusion criteria for germany: male subjects who are sexually active and have partners who are or could be pregnant, not using a barrier method of contraception (e.g. condom) for the duration of the trial and for 30 days following the last dose of trial medication
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C0009653 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0032961 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C3831118 (UMLS CUI [4,3])
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