ID

38992

Description

Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02128932

Link

https://clinicaltrials.gov/show/NCT02128932

Keywords

Versions (1)
  1. 11/18/19 11/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02128932

English

Eligibility Diabetes NCT02128932

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02128932
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, 18 years or older at the time of signing informed consent
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and su (metformin 1500 mg or higher or maximum tolerated dose and su half of maximum allowed dose according to national label or higher) for at least 90 days before screening. stable is defined as unchanged medication and unchanged dose
Description

Insulin Absent | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Stable | Metformin Dose | Metformin Maximum Tolerated Dose | Sulfonylurea | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C3274787
UMLS CUI [3,2]
C0205360
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C0025598
UMLS CUI [5,2]
C0752079
UMLS CUI [6]
C0038766
UMLS CUI [7]
C0009429
hba1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
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 of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
Description

Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
any disorder which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
Description

Disease At risk Patient safety | Disease Protocol Compliance At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C1444641
treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
Description

Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0557978
UMLS CUI [3,3]
C0443303
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0009488
history of chronic or idiopathic acute pancreatitis
Description

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
screening calcitonin value greater than or equal to 50 ng/l
Description

Calcitonin measurement

Data type

boolean

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

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of 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
UMLS CUI [4,1]
C4039247
UMLS CUI [4,2]
C0332307
severe renal impairment defined as estimated glomerular filtration rate (egfr) less than 30 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
Description

Renal Insufficiency Severe | Renal function GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2170215
acute coronary or cerebrovascular event within 90 days before randomisation
Description

Acute Coronary Syndrome | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
heart failure, new york heart association class iv
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Description

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Description

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Data type

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
mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Description

Mental handicap Excludes Comprehension Study Protocol | Mental handicap Excludes Protocol Compliance | Study Protocol Comprehension Unwilling | Protocol Compliance Unwilling | Language Barriers Exclude Comprehension Study Protocol | Language Barriers Exclude Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C1306341
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C2348563
UMLS CUI [3,2]
C0162340
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C0558080
UMLS CUI [5,1]
C0237167
UMLS CUI [5,2]
C0332196
UMLS CUI [5,3]
C0162340
UMLS CUI [5,4]
C2348563
UMLS CUI [6,1]
C0237167
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C0525058
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Similar models

Eligibility Diabetes NCT02128932

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02128932
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
male or female, 18 years or older at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Insulin Absent | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Stable | Metformin Dose | Metformin Maximum Tolerated Dose | Sulfonylurea | Combined Modality Therapy
Item
insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and su (metformin 1500 mg or higher or maximum tolerated dose and su half of maximum allowed dose according to national label or higher) for at least 90 days before screening. stable is defined as unchanged medication and unchanged dose
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2])
C3274787 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0025598 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
C0038766 (UMLS CUI [6])
C0009429 (UMLS CUI [7])
Hemoglobin A1c measurement
Item
hba1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Disease At risk Patient safety | Disease Protocol Compliance At risk
Item
any disorder which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity
Item
treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0557978 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0009488 (UMLS CUI [4,2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin value greater than or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C4039247 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
Renal Insufficiency Severe | Renal function GFR estimation by MDRD
Item
severe renal impairment defined as estimated glomerular filtration rate (egfr) less than 30 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Acute Coronary Syndrome | Cerebrovascular accident
Item
acute coronary or cerebrovascular event within 90 days before randomisation
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
heart failure, new york heart association class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
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])
Mental handicap Excludes Comprehension Study Protocol | Mental handicap Excludes Protocol Compliance | Study Protocol Comprehension Unwilling | Protocol Compliance Unwilling | Language Barriers Exclude Comprehension Study Protocol | Language Barriers Exclude Protocol Compliance
Item
mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C1306341 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C2348563 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0525058 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0237167 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0162340 (UMLS CUI [5,3])
C2348563 (UMLS CUI [5,4])
C0237167 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
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