ID

38944

Descripción

The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01676116

Link

https://clinicaltrials.gov/show/NCT01676116

Palabras clave

Versiones (1)
  1. 14/11/19 14/11/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

14 de noviembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT01676116

Inglés

Eligibility Diabetes NCT01676116

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01676116
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 diabetes mellitus
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

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

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
treatment with daily glp-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (od) victoza® (liraglutide) or 10 microgram twice daily (bid) byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg od victoza®
Descripción

GLP-1 Receptor Agonist Dose Maximum | Victoza Dose times/day | Liraglutide Dose times/day | Byetta Dose times/day | Exenatide Dose times/day | Victoza Maximum Tolerated Dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2917359
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C2732208
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0439511
UMLS CUI [3,1]
C1456408
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0439511
UMLS CUI [4,1]
C1636686
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0439511
UMLS CUI [5,1]
C0167117
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0439511
UMLS CUI [6,1]
C2732208
UMLS CUI [6,2]
C0752079
(liraglutide) or 5 microgram bid byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (visit 1)
Descripción

Liraglutide Maximum Tolerated Dose | Byetta Maximum Tolerated Dose | Exenatide Maximum Tolerated Dose | Combined Modality Therapy | Metformin Dose U/day | Metformin Maximum Tolerated Dose

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1456408
UMLS CUI [1,2]
C0752079
UMLS CUI [2,1]
C1636686
UMLS CUI [2,2]
C0752079
UMLS CUI [3,1]
C0167117
UMLS CUI [3,2]
C0752079
UMLS CUI [4]
C0009429
UMLS CUI [5,1]
C0025598
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0456683
UMLS CUI [6,1]
C0025598
UMLS CUI [6,2]
C0752079
bmi (body mass index) equal to or below 40 kg/m^2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
any use of oral anti-diabetic drugs (oads) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (visit 1)
Descripción

Antidiabetics Oral | Exception Metformin | Exception Pioglitazone | Exception Sulfonylurea

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0071097
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0038766
use of any drug (except metformin,pioglitazone, sulphonylurea and glp-1 receptor agonist) which in the investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
Descripción

Pharmaceutical Preparations Interfere with Blood glucose level | CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Metformin | Exception Pioglitazone | Exception Sulfonylurea | Exception GLP-1 Receptor Agonis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0392201
UMLS CUI [2]
C3653708
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025598
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0071097
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0038766
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C2917359
treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator)
Descripción

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

Tipo de datos

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 equal to or above 50 ng/l
Descripción

Calcitonin measurement

Tipo de datos

boolean

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

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

Tipo de datos

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
Descripción

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 datos

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
Descripción

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

Tipo de datos

boolean

Alias
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]
C0332121
subjects with a clinically 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 products
Descripción

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 datos

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
Descripción

Pancreatitis, Chronic | Idiopathic acute pancreatitis

Tipo de datos

boolean

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

Eligibility Diabetes NCT01676116

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01676116
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
glycosylated haemoglobin (hba1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
GLP-1 Receptor Agonist Dose Maximum | Victoza Dose times/day | Liraglutide Dose times/day | Byetta Dose times/day | Exenatide Dose times/day | Victoza Maximum Tolerated Dose
Item
treatment with daily glp-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (od) victoza® (liraglutide) or 10 microgram twice daily (bid) byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg od victoza®
boolean
C2917359 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C2732208 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0439511 (UMLS CUI [2,3])
C1456408 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0439511 (UMLS CUI [3,3])
C1636686 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0439511 (UMLS CUI [4,3])
C0167117 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0439511 (UMLS CUI [5,3])
C2732208 (UMLS CUI [6,1])
C0752079 (UMLS CUI [6,2])
Liraglutide Maximum Tolerated Dose | Byetta Maximum Tolerated Dose | Exenatide Maximum Tolerated Dose | Combined Modality Therapy | Metformin Dose U/day | Metformin Maximum Tolerated Dose
Item
(liraglutide) or 5 microgram bid byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (visit 1)
boolean
C1456408 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C1636686 (UMLS CUI [2,1])
C0752079 (UMLS CUI [2,2])
C0167117 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0009429 (UMLS CUI [4])
C0025598 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
C0025598 (UMLS CUI [6,1])
C0752079 (UMLS CUI [6,2])
Body mass index
Item
bmi (body mass index) equal to or below 40 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral | Exception Metformin | Exception Pioglitazone | Exception Sulfonylurea
Item
any use of oral anti-diabetic drugs (oads) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (visit 1)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0071097 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0038766 (UMLS CUI [4,2])
Pharmaceutical Preparations Interfere with Blood glucose level | CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Metformin | Exception Pioglitazone | Exception Sulfonylurea | Exception GLP-1 Receptor Agonis
Item
use of any drug (except metformin,pioglitazone, sulphonylurea and glp-1 receptor agonist) which in the investigator's 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])
C3653708 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0071097 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038766 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C2917359 (UMLS CUI [6,2])
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 equal to or above 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 Treatment required for | Macular retinal edema Treatment required for
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 [2,1])
C0332121 (UMLS CUI [2,2])
C0271051 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
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 clinically 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 products
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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