ID

35797

Description

A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02212067

Link

https://clinicaltrials.gov/show/NCT02212067

Keywords

Versions (1)
  1. 3/24/19 3/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02212067

English

Eligibility Diabetes NCT02212067

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02212067
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 18-64 years (both inclusive) at the time of signing the informed consent
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
for subjects with type 2 diabetes:
Description

Study Subject Non-Insulin-Dependent Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0011860
male and female subjects diagnosed with type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
treated with diet and exercise and/or metformin monotherapy. metformin dose should be unchanged in a period of 30 days prior to screening
Description

Diet therapy | Exercise | Metformin Dosage unchanged

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0442739
body mass index (bmi) between 20.0-35.0 kg/m^2 (both inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
glycosylated haemoglobin (hba1c) between 6.5-9.0 % (both inclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
for healthy control group for graded glucose infusion:
Description

Healthy Control | Glucose Injection

Data type

boolean

Alias
UMLS CUI [1]
C2986479
UMLS CUI [2]
C4257321
healthy male and female subjects
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
bmi between 24.0-32.0 kg/m^2 (both inclusive)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c less than 6.5 %
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female who is pregnant, breast-feeding or intends to become pregnant or is of child bearing potential and not using an adequate contraceptive method. women of child bearing potential must use an effective method of birth control for the duration of the trial and for subjects with type 2 diabetes for 5 weeks following the last dose of semaglutide. only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Contraceptive methods | Contraceptive implant | Contraceptive injection | Oral Contraceptives Combined | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy

Data type

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 [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [6]
C1657106
UMLS CUI [7]
C1656586
UMLS CUI [8,1]
C0009905
UMLS CUI [8,2]
C0205195
UMLS CUI [9]
C0021900
UMLS CUI [10]
C0036899
UMLS CUI [11]
C0420842
any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic
Description

Medical History Clinical Significance | Systemic disease | Organ Disease | Heart Diseases | Lung diseases | Gastrointestinal Diseases | Liver diseases | Nervous system disorder | Kidney Diseases | Disorder of the genitourinary system | Endocrine System Diseases | Dermatologic disorders | Hematological Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0442893
UMLS CUI [3,1]
C0178784
UMLS CUI [3,2]
C0012634
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0022658
UMLS CUI [10]
C0080276
UMLS CUI [11]
C0014130
UMLS CUI [12]
C0037274
UMLS CUI [13]
C0018939
use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically: a) current treatment with systemic (oral or i.v.) corticosteroids, non-selective betablockers, b) thyroid hormones are not allowed unless the use of these have been stable during the past 2 month prior to screening
Description

Prescription Drugs Interfere with Research results Pharmacokinetic | Prescription Drugs Interfere with Research results Pharmacodynamic | Non-Prescription Drugs Interfere with Research results Pharmacokinetic | Non-Prescription Drugs Interfere with Research results Pharmacodynamic | CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Intravenous | Non-selective beta-blocking agent | Thyroid Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0304227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [1,4]
C0031328
UMLS CUI [2,1]
C0304227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [2,4]
C0851347
UMLS CUI [3,1]
C0013231
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [3,4]
C0031328
UMLS CUI [4,1]
C0013231
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [4,4]
C0851347
UMLS CUI [5,1]
C3653708
UMLS CUI [5,2]
C1527415
UMLS CUI [6,1]
C3653708
UMLS CUI [6,2]
C1522726
UMLS CUI [7]
C0304515
UMLS CUI [8]
C0040135
history of drug/chemical substance abuse within 1 year prior to screening, or a positive result in the urine drug test
Description

Substance Use Disorders | Urine drug screening Positive

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0202274
UMLS CUI [2,2]
C1514241
history of alcohol abuse within 1 year prior to screening, or a positive result in the alcohol breath test
Description

Alcohol abuse | Alcohol breath testing Positive

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2,1]
C0202306
UMLS CUI [2,2]
C1514241
smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
Description

Tobacco use Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Description

Refrain from Smoking Unable | Refrain from Smoking Unwilling | Nicotine Chewing Gum Discontinue Unable | Nicotine Transdermal Patch Discontinue Unable | Nicotine Chewing Gum Discontinue Unwilling | Nicotine Transdermal Patch Discontinue Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C4086797
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C4086797
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0599654
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0358855
UMLS CUI [4,2]
C1444662
UMLS CUI [4,3]
C1299582
UMLS CUI [5,1]
C0599654
UMLS CUI [5,2]
C1444662
UMLS CUI [5,3]
C0558080
UMLS CUI [6,1]
C0358855
UMLS CUI [6,2]
C1444662
UMLS CUI [6,3]
C0558080
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Similar models

Eligibility Diabetes NCT02212067

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02212067
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
age: 18-64 years (both inclusive) at the time of signing the informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Study Subject Non-Insulin-Dependent Diabetes Mellitus
Item
for subjects with type 2 diabetes:
boolean
C0681850 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
male and female subjects diagnosed with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Exercise | Metformin Dosage unchanged
Item
treated with diet and exercise and/or metformin monotherapy. metformin dose should be unchanged in a period of 30 days prior to screening
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
Body mass index
Item
body mass index (bmi) between 20.0-35.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) between 6.5-9.0 % (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Healthy Control | Glucose Injection
Item
for healthy control group for graded glucose infusion:
boolean
C2986479 (UMLS CUI [1])
C4257321 (UMLS CUI [2])
Healthy Volunteers
Item
healthy male and female subjects
boolean
C1708335 (UMLS CUI [1])
Body mass index
Item
bmi between 24.0-32.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c less than 6.5 %
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Contraceptive methods | Contraceptive implant | Contraceptive injection | Oral Contraceptives Combined | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child bearing potential and not using an adequate contraceptive method. women of child bearing potential must use an effective method of birth control for the duration of the trial and for subjects with type 2 diabetes for 5 weeks following the last dose of semaglutide. only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner
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])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C1657106 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C0009905 (UMLS CUI [8,1])
C0205195 (UMLS CUI [8,2])
C0021900 (UMLS CUI [9])
C0036899 (UMLS CUI [10])
C0420842 (UMLS CUI [11])
Medical History Clinical Significance | Systemic disease | Organ Disease | Heart Diseases | Lung diseases | Gastrointestinal Diseases | Liver diseases | Nervous system disorder | Kidney Diseases | Disorder of the genitourinary system | Endocrine System Diseases | Dermatologic disorders | Hematological Disease
Item
any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic
boolean
C0262926 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2])
C0178784 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0080276 (UMLS CUI [10])
C0014130 (UMLS CUI [11])
C0037274 (UMLS CUI [12])
C0018939 (UMLS CUI [13])
Prescription Drugs Interfere with Research results Pharmacokinetic | Prescription Drugs Interfere with Research results Pharmacodynamic | Non-Prescription Drugs Interfere with Research results Pharmacokinetic | Non-Prescription Drugs Interfere with Research results Pharmacodynamic | CORTICOSTEROIDS FOR SYSTEMIC USE Oral | CORTICOSTEROIDS FOR SYSTEMIC USE Intravenous | Non-selective beta-blocking agent | Thyroid Hormones
Item
use of any prescription or non-prescription medication which could interfere with trial pharmacokinetic or pharmacodynamic results, as judged by the investigator or specifically: a) current treatment with systemic (oral or i.v.) corticosteroids, non-selective betablockers, b) thyroid hormones are not allowed unless the use of these have been stable during the past 2 month prior to screening
boolean
C0304227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,4])
C0304227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0851347 (UMLS CUI [2,4])
C0013231 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0031328 (UMLS CUI [3,4])
C0013231 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C0851347 (UMLS CUI [4,4])
C3653708 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C3653708 (UMLS CUI [6,1])
C1522726 (UMLS CUI [6,2])
C0304515 (UMLS CUI [7])
C0040135 (UMLS CUI [8])
Substance Use Disorders | Urine drug screening Positive
Item
history of drug/chemical substance abuse within 1 year prior to screening, or a positive result in the urine drug test
boolean
C0038586 (UMLS CUI [1])
C0202274 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Alcohol abuse | Alcohol breath testing Positive
Item
history of alcohol abuse within 1 year prior to screening, or a positive result in the alcohol breath test
boolean
C0085762 (UMLS CUI [1])
C0202306 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Tobacco use Number of cigarettes per day
Item
smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Refrain from Smoking Unable | Refrain from Smoking Unwilling | Nicotine Chewing Gum Discontinue Unable | Nicotine Transdermal Patch Discontinue Unable | Nicotine Chewing Gum Discontinue Unwilling | Nicotine Transdermal Patch Discontinue Unwilling
Item
not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
boolean
C4086797 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0599654 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0358855 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
C0599654 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
C0358855 (UMLS CUI [6,1])
C1444662 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
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