ID

38966

Description

Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01885208

Link

https://clinicaltrials.gov/show/NCT01885208

Keywords

Versions (1)
  1. 11/16/19 11/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01885208

English

Eligibility Diabetes NCT01885208

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01885208
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 oads (metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (tzd) and sulfonylureas (sus) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. stable is defined as unchanged medication and unchanged dose
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Stable | Antidiabetics Oral Quantity | Metformin Dose | Metformin Maximum Tolerated Dose | Thiazolidinediones | Sulfonylurea

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C3274787
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0178602
UMLS CUI [5,1]
C0025598
UMLS CUI [5,2]
C0752079
UMLS CUI [6]
C1257987
UMLS CUI [7]
C0038766
hba1c 7.0 - 10.5 % (53 - 91 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
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice)
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 chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
Description

Chronic disease At risk Patient safety | Disease Severe At risk Patient safety | Chronic disease At risk Protocol Compliance | Disease Severe At risk Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C1444641
UMLS CUI [4,4]
C0525058
treatment with 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 inter-current 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 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 (mtc) or multiple endocrine neoplasia syndrome type 2 (men 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
impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
Description

Renal Insufficiency | Renal function GFR estimation by MDRD

Data type

boolean

Alias
UMLS CUI [1]
C1565489
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 (nyha) class iv
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
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Similar models

Eligibility Diabetes NCT01885208

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01885208
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Therapy Stable | Antidiabetics Oral Quantity | Metformin Dose | Metformin Maximum Tolerated Dose | Thiazolidinediones | Sulfonylurea
Item
subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 oads (metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (tzd) and sulfonylureas (sus) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. stable is defined as unchanged medication and unchanged dose
boolean
C0011860 (UMLS CUI [1])
C3274787 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0025598 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0025598 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
C1257987 (UMLS CUI [6])
C0038766 (UMLS CUI [7])
Hemoglobin A1c measurement
Item
hba1c 7.0 - 10.5 % (53 - 91 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
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice)
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])
Chronic disease At risk Patient safety | Disease Severe At risk Patient safety | Chronic disease At risk Protocol Compliance | Disease Severe At risk Protocol Compliance
Item
any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
boolean
C0008679 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0008679 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
Hypoglycemic Agents | Exception Inclusion criteria | Exception Insulin regime short-term | Relationship Comorbidity
Item
treatment with 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 inter-current 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 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 | Family history of multiple endocrine neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 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 | Renal function GFR estimation by MDRD
Item
impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m^2 per modification of diet in renal disease (mdrd) formula (4 variable version)
boolean
C1565489 (UMLS CUI [1])
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 (nyha) class iv
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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