ID

38896

Description

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01392573

Link

https://clinicaltrials.gov/show/NCT01392573

Keywords

Versions (1)
  1. 11/12/19 11/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01392573

English

Eligibility Diabetes NCT01392573

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01392573
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
hba1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
subjects on stable daily doses for at least 90 days prior to trial start of: basal insulin (total daily basal insulin dose within the range of 20-40u in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and su (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
Description

Basal insulin Cumulative Dose U/day | Combined Modality Therapy | Metformin Dose U/day | Metformin Maximum Tolerated Dose | Sulfonylurea | Glinide [

Data type

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0456683
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0456683
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0752079
UMLS CUI [5]
C0038766
UMLS CUI [6]
C2266929
bmi (body mass index) more than or equal to 27 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with glucagon like peptide-1 (glp-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (dpp-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
Description

GLP-1 Receptor Agonist | exenatide | liraglutide | Dipeptidyl Peptidase 4 Inhibitors | Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1456408
UMLS CUI [4]
C2917254
UMLS CUI [5]
C1257987
impaired liver function
Description

Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
impaired renal function
Description

Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C1565489
screening calcitonin equal to or above 50 ng/l
Description

Calcitonin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201924
subjects with personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 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
cardiac disorder defined as: congestive heart failure (nyha class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures
Description

Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Myocardial Infarction | Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0027051
UMLS CUI [6,1]
C0877341
UMLS CUI [6,2]
C1301732
UMLS CUI [7,1]
C3495793
UMLS CUI [7,2]
C1301732
UMLS CUI [8,1]
C1096418
UMLS CUI [8,2]
C1301732
severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm hg or diastolic blood pressure equal to or above 100 mm hg)
Description

Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0332155
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
Description

Treatment required for Proliferative retinopathy | Treatment required for Disorder of macula of retina | Treatment required for Macular retinal edema

Data type

boolean

Alias
UMLS CUI [1,1]
C0332121
UMLS CUI [1,2]
C0339467
UMLS CUI [2,1]
C0332121
UMLS CUI [2,2]
C0730362
UMLS CUI [3,1]
C0332121
UMLS CUI [3,2]
C0271051
history of chronic pancreatitis or idiopathic acute pancreatitis
Description

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0341461
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Similar models

Eligibility Diabetes NCT01392573

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01392573
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
subjects with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin) 7.5-10.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Basal insulin Cumulative Dose U/day | Combined Modality Therapy | Metformin Dose U/day | Metformin Maximum Tolerated Dose | Sulfonylurea | Glinide [
Item
subjects on stable daily doses for at least 90 days prior to trial start of: basal insulin (total daily basal insulin dose within the range of 20-40u in combination with: metformin (1500 mg or more or max. tolerated dose) or metformin (1500 mg or more or max. tolerated dose) and su (sulfonylurea) (equal to or more than half of the max. approved dose according to local label) or metformin and glinides (equal to or more than half of the max. approved dose according to local label)
boolean
C0650607 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0009429 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C0025598 (UMLS CUI [4,1])
C0752079 (UMLS CUI [4,2])
C0038766 (UMLS CUI [5])
C2266929 (UMLS CUI [6])
Body mass index
Item
bmi (body mass index) more than or equal to 27 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
GLP-1 Receptor Agonist | exenatide | liraglutide | Dipeptidyl Peptidase 4 Inhibitors | Thiazolidinediones
Item
treatment with glucagon like peptide-1 (glp-1) receptor agonists (e.g. exenatide, liraglutide), dipeptidyl peptidase 4 (dpp-4) inhibitors and/or thiazolidinediones within 90 days prior to trial start
boolean
C2917359 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
C2917254 (UMLS CUI [4])
C1257987 (UMLS CUI [5])
Liver Dysfunction
Item
impaired liver function
boolean
C0086565 (UMLS CUI [1])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Calcitonin measurement
Item
screening calcitonin equal to or above 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type
Item
subjects with personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Myocardial Infarction | Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned
Item
cardiac disorder defined as: congestive heart failure (nyha class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 52 weeks prior to trial start and/or planned coronary, carotid or peripheral artery revascularisation procedures
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0877341 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
C3495793 (UMLS CUI [7,1])
C1301732 (UMLS CUI [7,2])
C1096418 (UMLS CUI [8,1])
C1301732 (UMLS CUI [8,2])
Uncontrolled hypertension Severe Treated | Uncontrolled hypertension Severe Untreated | Systolic Pressure | Diastolic blood pressure
Item
severe uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mm hg or diastolic blood pressure equal to or above 100 mm hg)
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Treatment required for Proliferative retinopathy | Treatment required for Disorder of macula of retina | Treatment required for Macular retinal edema
Item
acute treatment required proliferative retinopathy or maculopathy (macular oedema) according to physician's opinion
boolean
C0332121 (UMLS CUI [1,1])
C0339467 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2,1])
C0730362 (UMLS CUI [2,2])
C0332121 (UMLS CUI [3,1])
C0271051 (UMLS CUI [3,2])
Pancreatitis, Chronic | Idiopathic acute pancreatitis
Item
history of chronic pancreatitis or idiopathic acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0341461 (UMLS CUI [2])
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