ID

29213

Beschreibung

Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00447382

Link

https://clinicaltrials.gov/show/NCT00447382

Stichworte

Versionen (1)
  1. 08.03.18 08.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. März 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT00447382

Englisch

Eligibility Diabetes NCT00447382

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00447382
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 1 diabetes for at least 12 months
Beschreibung

Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
basal-bolus treatment for at least 3 months
Beschreibung

Basal insulin Bolus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C1705509
body mass index (bmi) less than or equal to 35.0 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
hba1c (glycosylated haemoglobin) less than or equal to 12.0%
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to trial products or related products
Beschreibung

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

Datentyp

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
pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
receipt of any trial drug within 1 month prior to this trial
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Beschreibung

Mental handicap Excludes Comprehension Study Protocol | Comprehension Study Protocol Unwilling | Language problems Exclude Comprehension Study Protocol | Mental handicap Excludes Compliance behavior | Compliance behavior Unwilling | Language problems Exclude Compliance behavior

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C1405458
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0162340
UMLS CUI [3,4]
C2348563
UMLS CUI [4,1]
C1306341
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C1321605
UMLS CUI [5,1]
C1321605
UMLS CUI [5,2]
C0558080
UMLS CUI [6,1]
C1405458
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C1321605
conditions that may interfere with trial participation as judged by investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)
Beschreibung

Condition Interferes with Study Subject Participation Status | Proliferative retinopathy | Disorder of macula of retina Treatment required for | Recurrent severe hypoglycemia | Liver Dysfunction | Renal Insufficiency | Cardiac problem | Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2]
C0339467
UMLS CUI [3,1]
C0730362
UMLS CUI [3,2]
C0332121
UMLS CUI [4]
C0342316
UMLS CUI [5]
C0086565
UMLS CUI [6]
C1565489
UMLS CUI [7]
C0262402
UMLS CUI [8]
C1868885
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Ähnliche Modelle

Eligibility Diabetes NCT00447382

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00447382
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length
Item
type 1 diabetes for at least 12 months
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Basal insulin Bolus
Item
basal-bolus treatment for at least 3 months
boolean
C0650607 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
Body mass index
Item
body mass index (bmi) less than or equal to 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin) less than or equal to 12.0%
boolean
C0202054 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy 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])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Investigational New Drugs
Item
receipt of any trial drug within 1 month prior to this trial
boolean
C0013230 (UMLS CUI [1])
Mental handicap Excludes Comprehension Study Protocol | Comprehension Study Protocol Unwilling | Language problems Exclude Comprehension Study Protocol | Mental handicap Excludes Compliance behavior | Compliance behavior Unwilling | Language problems Exclude Compliance behavior
Item
mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1405458 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0162340 (UMLS CUI [3,3])
C2348563 (UMLS CUI [3,4])
C1306341 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C1321605 (UMLS CUI [4,3])
C1321605 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C1405458 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C1321605 (UMLS CUI [6,3])
Condition Interferes with Study Subject Participation Status | Proliferative retinopathy | Disorder of macula of retina Treatment required for | Recurrent severe hypoglycemia | Liver Dysfunction | Renal Insufficiency | Cardiac problem | Uncontrolled hypertension
Item
conditions that may interfere with trial participation as judged by investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0339467 (UMLS CUI [2])
C0730362 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0342316 (UMLS CUI [4])
C0086565 (UMLS CUI [5])
C1565489 (UMLS CUI [6])
C0262402 (UMLS CUI [7])
C1868885 (UMLS CUI [8])
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