ID

36696

Description

Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02453711

Link

https://clinicaltrials.gov/show/NCT02453711

Keywords

Versions (1)
  1. 6/2/19 6/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Obesity NCT02453711

English

Eligibility Obesity NCT02453711

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02453711
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Description

Informed Consent | Status pre- Clinical Trial Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0184661
male or female, age 18 years or older at the time of signing inform consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) equal or above 30.0 kg/m^2 at the screening visit
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
at least one unsuccessful weight loss attempt per investigator judgement
Description

Weight loss Attempt Quantity Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C1516084
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1272705
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a hba1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
Description

Hemoglobin A1c measurement | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0011860
treatment with glucose lowering agent(s) within 90 days before screening
Description

Hypoglycemic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0020616
screening calcitonin equal to or above 50 ng/l (pg/ml)
Description

Calcitonin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201924
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
Description

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type

Data type

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
history of pancreatitis (acute or chronic)
Description

Pancreatitis | Pancreatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
obesity induced by endocrine disorders (e.g. cushing syndrome)
Description

Obesity of endocrine origin | Cushing Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0267992
UMLS CUI [2]
C0010481
treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change
Description

Pharmaceutical Preparation Causing Body Weight Change

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0005911
previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed)
Description

Operative Surgical Procedures Obesity | Suction Lipectomy Previous allowed | Abdominoplasty Previous allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0028754
UMLS CUI [2,1]
C0038640
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0198542
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C0683607
history of major depressive disorder within 2 years before randomisation
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
any lifetime history of a suicidal attempt
Description

Suicide attempt

Data type

boolean

Alias
UMLS CUI [1]
C0038663
female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
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Similar models

Eligibility Obesity NCT02453711

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02453711
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Status pre- Clinical Trial Procedures
Item
informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
Age
Item
male or female, age 18 years or older at the time of signing inform consent
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) equal or above 30.0 kg/m^2 at the screening visit
boolean
C1305855 (UMLS CUI [1])
Weight loss Attempt Quantity Unsuccessful
Item
at least one unsuccessful weight loss attempt per investigator judgement
boolean
C1262477 (UMLS CUI [1,1])
C1516084 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Hemoglobin A1c measurement | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
a hba1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus
boolean
C0474680 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Hypoglycemic Agents
Item
treatment with glucose lowering agent(s) within 90 days before screening
boolean
C0020616 (UMLS CUI [1])
Calcitonin measurement
Item
screening calcitonin equal to or above 50 ng/l (pg/ml)
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Obesity of endocrine origin | Cushing Syndrome
Item
obesity induced by endocrine disorders (e.g. cushing syndrome)
boolean
C0267992 (UMLS CUI [1])
C0010481 (UMLS CUI [2])
Pharmaceutical Preparation Causing Body Weight Change
Item
treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0005911 (UMLS CUI [1,3])
Operative Surgical Procedures Obesity | Suction Lipectomy Previous allowed | Abdominoplasty Previous allowed
Item
previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed)
boolean
C0543467 (UMLS CUI [1,1])
C0028754 (UMLS CUI [1,2])
C0038640 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0198542 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Major Depressive Disorder
Item
history of major depressive disorder within 2 years before randomisation
boolean
C1269683 (UMLS CUI [1])
Suicide attempt
Item
any lifetime history of a suicidal attempt
boolean
C0038663 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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