ID

38940

Descrição

The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01618162

Link

https://clinicaltrials.gov/show/NCT01618162

Palavras-chave

Versões (1)
  1. 14/11/2019 14/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

14 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT01618162

Inglês

Eligibility Diabetes NCT01618162

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01618162
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 diabetes mellitus
Descrição

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
hba1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (visit 1)
Descrição

Sulfonylurea Dose Stable Daily | Metformin Dose | Metformin Maximum Tolerated Dose | Metformin Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0038766
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0332173
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0752079
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0332197
body mass index (bmi) below or equal to 40 kg/m^2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any use of oral anti-diabetic drugs (oads) (other than su in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (visit 1)
Descrição

Antidiabetics Oral | Exception Sulfonylurea | Exception Combined Modality Therapy Metformin

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0038766
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0009429
UMLS CUI [3,3]
C0025598
use of any drug (other than su in monotherapy or in combination with metformin), which in the investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
Descrição

Pharmaceutical Preparations Interfere with Blood glucose level | Exception Sulfonylurea | Exception Combined Modality Therapy Metformin | CORTICOSTEROIDS FOR SYSTEMIC USE

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0392201
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0038766
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0009429
UMLS CUI [3,3]
C0025598
UMLS CUI [4]
C3653708
previous treatment with glucagon-like peptide-1 (glp-1) receptor agonist (e.g. exenatide, liraglutide)
Descrição

GLP-1 Receptor Agonist | exenatide | liraglutide

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1456408
treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator)
Descrição

Insulin regime | Treatment short-term allowed | Etiology Comorbidity | Etiology Gestational Diabetes

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0009488
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0085207
screening calcitonin above or equal to 50 ng/l
Descrição

Calcitonin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201924
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men2)
Descrição

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type

Tipo de dados

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
cardiovascular disorders defined as: congestive heart failure (new york heart association (nyha) class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (visit 1) and/or planned coronary,carotid or peripheral artery revascularisation procedures
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
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
proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the investigator's opinion
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2]
C0730362
UMLS CUI [3]
C0271051
subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus),neurological, genitourinary or haematological system that in the opinion of the investigator,may confound the results of the trial or pose additional risk in administering trial product
Descrição

Disease Interferes with Research results | Disease Investigational New Drugs At risk | Gastrointestinal Disease | Lung disease | Endocrine System Disease | Exception Non-Insulin-Dependent Diabetes Mellitus | Nervous system disorder | Disorder of the genitourinary system | Hematological Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1444641
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0014130
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0011860
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0080276
UMLS CUI [9]
C0018939
history of chronic pancreatitis or idiopathic acute pancreatitis
Descrição

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Tipo de dados

boolean

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

Eligibility Diabetes NCT01618162

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01618162
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
subjects with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Sulfonylurea Dose Stable Daily | Metformin Dose | Metformin Maximum Tolerated Dose | Metformin Absent
Item
subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (visit 1)
boolean
C0038766 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Body mass index
Item
body mass index (bmi) below or equal to 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | Exception Sulfonylurea | Exception Combined Modality Therapy Metformin
Item
any use of oral anti-diabetic drugs (oads) (other than su in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (visit 1)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0009429 (UMLS CUI [3,2])
C0025598 (UMLS CUI [3,3])
Pharmaceutical Preparations Interfere with Blood glucose level | Exception Sulfonylurea | Exception Combined Modality Therapy Metformin | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
use of any drug (other than su in monotherapy or in combination with metformin), which in the investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0392201 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0009429 (UMLS CUI [3,2])
C0025598 (UMLS CUI [3,3])
C3653708 (UMLS CUI [4])
GLP-1 Receptor Agonist | exenatide | liraglutide
Item
previous treatment with glucagon-like peptide-1 (glp-1) receptor agonist (e.g. exenatide, liraglutide)
boolean
C2917359 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
Insulin regime | Treatment short-term allowed | Etiology Comorbidity | Etiology Gestational Diabetes
Item
treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator)
boolean
C0557978 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0009488 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0085207 (UMLS CUI [4,2])
Calcitonin measurement
Item
screening calcitonin above 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 (mtc) or multiple endocrine neoplasia type 2 (men2)
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])
Cardiovascular Diseases | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cerebrovascular accident | Myocardial Infarction | Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned
Item
cardiovascular disorders defined as: congestive heart failure (new york heart association (nyha) class iii-iv), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (visit 1) and/or planned coronary,carotid or peripheral artery revascularisation procedures
boolean
C0007222 (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])
Proliferative retinopathy Treatment required for | Disorder of macula of retina | Macular retinal edema
Item
proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the investigator's opinion
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2])
C0271051 (UMLS CUI [3])
Disease Interferes with Research results | Disease Investigational New Drugs At risk | Gastrointestinal Disease | Lung disease | Endocrine System Disease | Exception Non-Insulin-Dependent Diabetes Mellitus | Nervous system disorder | Disorder of the genitourinary system | Hematological Disease
Item
subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus),neurological, genitourinary or haematological system that in the opinion of the investigator,may confound the results of the trial or pose additional risk in administering trial product
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0017178 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0011860 (UMLS CUI [6,2])
C0027765 (UMLS CUI [7])
C0080276 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
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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