ID

38873

Beschrijving

Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™); ODM derived from: https://clinicaltrials.gov/show/NCT01135992

Link

https://clinicaltrials.gov/show/NCT01135992

Trefwoorden

Versies (1)
  1. 11-11-19 11-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 november 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes NCT01135992

Engels

Eligibility Diabetes NCT01135992

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01135992
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c maximum 10 % by central laboratory analysis
Beschrijving

Hemoglobin A1c measurement Maximum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C0806909
current treatment with basal-oral therapy (bot) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to visit 1) oad (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination
Beschrijving

Therapy Oral Basal | Insulin Mealtime Absent | Insulin Glargine times per day | Dose unchanged | Combined Modality Therapy | Antidiabetics Oral Stable | Metformin | Pills Releasing Insulin | pioglitazone | sitagliptin | alpha-Glucosidase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0205112
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0587119
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0907402
UMLS CUI [3,2]
C0439511
UMLS CUI [4,1]
C0178602
UMLS CUI [4,2]
C0442739
UMLS CUI [5]
C0009429
UMLS CUI [6,1]
C0935929
UMLS CUI [6,2]
C1527415
UMLS CUI [6,3]
C0205360
UMLS CUI [7]
C0025598
UMLS CUI [8,1]
C0994475
UMLS CUI [8,2]
C1283071
UMLS CUI [8,3]
C0021641
UMLS CUI [9]
C0071097
UMLS CUI [10]
C1565750
UMLS CUI [11]
C1299007
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
use within the last three months prior to visit 1 of: exenatide, liraglutide or thiazoledinediones (tzds) other than pioglitazone
Beschrijving

exenatide | liraglutide | Thiazolidinediones | Exception Pioglitazone

Datatype

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2]
C1456408
UMLS CUI [3]
C1257987
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0071097
cardiovascular disease (cvd) defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty within the last six months prior to visit 1
Beschrijving

Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0581377
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0010055
UMLS CUI [7]
C0162577
recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
Beschrijving

Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Datatype

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0342317
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0011880
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Beschrijving

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
previous participation in this trial. participation is defined as started on trial medication. rescreening of screening failures is allowed only once within the limits of the recruitment period
Beschrijving

StudyStudy Subject Participation Status | Investigational New Drugs Started

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1272689
known or suspected hypersensitivity to trial products or related products
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
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Similar models

Eligibility Diabetes NCT01135992

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01135992
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement Maximum
Item
hba1c maximum 10 % by central laboratory analysis
boolean
C0474680 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
Therapy Oral Basal | Insulin Mealtime Absent | Insulin Glargine times per day | Dose unchanged | Combined Modality Therapy | Antidiabetics Oral Stable | Metformin | Pills Releasing Insulin | pioglitazone | sitagliptin | alpha-Glucosidase Inhibitors
Item
current treatment with basal-oral therapy (bot) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to visit 1) oad (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination
boolean
C0087111 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205112 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2,1])
C0587119 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0907402 (UMLS CUI [3,1])
C0439511 (UMLS CUI [3,2])
C0178602 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])
C0009429 (UMLS CUI [5])
C0935929 (UMLS CUI [6,1])
C1527415 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0025598 (UMLS CUI [7])
C0994475 (UMLS CUI [8,1])
C1283071 (UMLS CUI [8,2])
C0021641 (UMLS CUI [8,3])
C0071097 (UMLS CUI [9])
C1565750 (UMLS CUI [10])
C1299007 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
exenatide | liraglutide | Thiazolidinediones | Exception Pioglitazone
Item
use within the last three months prior to visit 1 of: exenatide, liraglutide or thiazoledinediones (tzds) other than pioglitazone
boolean
C0167117 (UMLS CUI [1])
C1456408 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0071097 (UMLS CUI [4,2])
Cardiovascular Disease | Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
cardiovascular disease (cvd) defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty within the last six months prior to visit 1
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0581377 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0162577 (UMLS CUI [7])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
boolean
C0342316 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0342317 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C0011880 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
StudyStudy Subject Participation Status | Investigational New Drugs Started
Item
previous participation in this trial. participation is defined as started on trial medication. rescreening of screening failures is allowed only once within the limits of the recruitment period
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1272689 (UMLS CUI [2,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
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