ID

24071

Beschreibung

Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00506662

Link

https://clinicaltrials.gov/show/NCT00506662

Stichworte

Versionen (1)
  1. 24.07.17 24.07.17 -
Hochgeladen am

24. Juli 2017

DOI

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Eligibility Diabetes NCT00506662

Englisch

Eligibility Diabetes NCT00506662

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00506662
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
insulin naive
Beschreibung

Insulin naive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
treatment with oral anti-diabetic drugs (oads) for at least 3 months and not achieving therapeutic targets
Beschreibung

Antidiabetics Oral | Target Therapeutic Unavailable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0302350
UMLS CUI [2,3]
C0686905
hba1c between 8% - 10.5%
Beschreibung

Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
secondary diabetes, mody (maturity onset diabetes of the young)
Beschreibung

Secondary diabetes mellitus | Maturity onset diabetes mellitus in young

Datentyp

boolean

Alias
UMLS CUI [1]
C0271640
UMLS CUI [2]
C0342276
previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the investigator)
Beschreibung

Insulin | Exclusion Insulin short-term Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C0443303
UMLS CUI [2,4]
C0009488
proliferative retinopathy, maculopathy requiring treatment,
Beschreibung

Proliferative retinopathy | Maculopathy Requirement Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0087111
hypoglycaemia unawareness as judged by the investigator, recurrent major hypoglycaemia
Beschreibung

Loss of hypoglycemic warning | Recurrent severe hypoglycemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2]
C0342316
end stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by mdrd (modification of diet in renal disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months
Beschreibung

End Stage Liver Disease | Elevated liver enzymes | Chronic Kidney Failure Modification of diet in renal disease formula | Dialysis | Heart failure | Cardiovascular event | Event Cerebrovascular

Datentyp

boolean

Alias
UMLS CUI [1]
C0745744
UMLS CUI [2]
C0235996
UMLS CUI [3,1]
C0022661
UMLS CUI [3,2]
C3839656
UMLS CUI [4]
C0011946
UMLS CUI [5]
C0018801
UMLS CUI [6]
C1320716
UMLS CUI [7,1]
C0441471
UMLS CUI [7,2]
C1880018
acute disease with poor prognosis
Beschreibung

Disease Prognosis bad

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0278252
history of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
Beschreibung

Alcoholic Intoxication, Chronic | Drug abuse | Mental disorders | Personality Disorders | Condition Interferes with Informed Consent | Condition Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013146
UMLS CUI [3]
C0004936
UMLS CUI [4]
C0031212
UMLS CUI [5,1]
C0348080
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0021430
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C0525058
mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous mmse (mini-mental state examination) in the last six months) and any conditions as judged by the investigator
Beschreibung

Mental handicap Excludes Comprehension | Comprehension Unwilling | Language Barriers Exclude Comprehension | Mental handicap Excludes Compliance behavior | Compliance behavior Unwilling | Language Barriers Exclude Compliance behavior | Mini-mental state examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0162340
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0237167
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0162340
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]
C0237167
UMLS CUI [6,2]
C0332196
UMLS CUI [6,3]
C1321605
UMLS CUI [7]
C0451306
legal incapacity or limited legal capacity (patients under guardianship or curatorship)
Beschreibung

Disability Legal | Limited function/disability Legal | Patient guardianship

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C1301860
UMLS CUI [2,1]
C0497533
UMLS CUI [2,2]
C1301860
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0870627
concomitant medication for alzheimers treatment (memantine, anticholinesterasique treatment)
Beschreibung

Pharmaceutical Preparations Alzheimer's Disease | Memantine | Cholinesterase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0002395
UMLS CUI [2]
C0025242
UMLS CUI [3]
C0008425
participation in another clinical trial less than one month before inclusion in this trial
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
illness requiring repeated hospitalisation
Beschreibung

Illness Requirement Hospitalization Repeated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0019993
UMLS CUI [1,4]
C0205341
known or suspected allergy to the insulin or any compositional component
Beschreibung

Insulin allergy | Hypersensitivity Insulin Component | Insulin allergy Suspected | Hypersensitivity Insulin Component Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0571622
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0021641
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0571622
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0021641
UMLS CUI [4,3]
C1705248
UMLS CUI [4,4]
C0750491
anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
Beschreibung

Pharmaceutical Preparation Interferes with Glucose metabolism | Systemic Corticosteroid Therapy | Prednisone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596620
UMLS CUI [2]
C4053960
UMLS CUI [3]
C0032952
any other condition that the investigator feels would interfere with trial participation or evaluation of results
Beschreibung

Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
terminal illness
Beschreibung

Terminal illness

Datentyp

boolean

Alias
UMLS CUI [1]
C0679247
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Ähnliche Modelle

Eligibility Diabetes NCT00506662

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00506662
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Insulin naive
Item
insulin naive
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Antidiabetics Oral | Target Therapeutic Unavailable
Item
treatment with oral anti-diabetic drugs (oads) for at least 3 months and not achieving therapeutic targets
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0302350 (UMLS CUI [2,2])
C0686905 (UMLS CUI [2,3])
Glycosylated hemoglobin A
Item
hba1c between 8% - 10.5%
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary diabetes mellitus | Maturity onset diabetes mellitus in young
Item
secondary diabetes, mody (maturity onset diabetes of the young)
boolean
C0271640 (UMLS CUI [1])
C0342276 (UMLS CUI [2])
Insulin | Exclusion Insulin short-term Comorbidity
Item
previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the investigator)
boolean
C0021641 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
Proliferative retinopathy | Maculopathy Requirement Therapeutic procedure
Item
proliferative retinopathy, maculopathy requiring treatment,
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Loss of hypoglycemic warning | Recurrent severe hypoglycemia
Item
hypoglycaemia unawareness as judged by the investigator, recurrent major hypoglycaemia
boolean
C0342317 (UMLS CUI [1])
C0342316 (UMLS CUI [2])
End Stage Liver Disease | Elevated liver enzymes | Chronic Kidney Failure Modification of diet in renal disease formula | Dialysis | Heart failure | Cardiovascular event | Event Cerebrovascular
Item
end stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by mdrd (modification of diet in renal disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months
boolean
C0745744 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
C0022661 (UMLS CUI [3,1])
C3839656 (UMLS CUI [3,2])
C0011946 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
C1320716 (UMLS CUI [6])
C0441471 (UMLS CUI [7,1])
C1880018 (UMLS CUI [7,2])
Disease Prognosis bad
Item
acute disease with poor prognosis
boolean
C0012634 (UMLS CUI [1,1])
C0278252 (UMLS CUI [1,2])
Alcoholic Intoxication, Chronic | Drug abuse | Mental disorders | Personality Disorders | Condition Interferes with Informed Consent | Condition Preventing Protocol Compliance
Item
history of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
boolean
C0001973 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0031212 (UMLS CUI [4])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0021430 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Mental handicap Excludes Comprehension | Comprehension Unwilling | Language Barriers Exclude Comprehension | Mental handicap Excludes Compliance behavior | Compliance behavior Unwilling | Language Barriers Exclude Compliance behavior | Mini-mental state examination
Item
mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous mmse (mini-mental state examination) in the last six months) and any conditions as judged by the investigator
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0162340 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0237167 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0162340 (UMLS CUI [3,3])
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])
C0237167 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C1321605 (UMLS CUI [6,3])
C0451306 (UMLS CUI [7])
Disability Legal | Limited function/disability Legal | Patient guardianship
Item
legal incapacity or limited legal capacity (patients under guardianship or curatorship)
boolean
C0231170 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
C0497533 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0870627 (UMLS CUI [3,2])
Pharmaceutical Preparations Alzheimer's Disease | Memantine | Cholinesterase Inhibitors
Item
concomitant medication for alzheimers treatment (memantine, anticholinesterasique treatment)
boolean
C0013227 (UMLS CUI [1,1])
C0002395 (UMLS CUI [1,2])
C0025242 (UMLS CUI [2])
C0008425 (UMLS CUI [3])
Study Subject Participation Status
Item
participation in another clinical trial less than one month before inclusion in this trial
boolean
C2348568 (UMLS CUI [1])
Illness Requirement Hospitalization Repeated
Item
illness requiring repeated hospitalisation
boolean
C0221423 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,4])
Insulin allergy | Hypersensitivity Insulin Component | Insulin allergy Suspected | Hypersensitivity Insulin Component Suspected
Item
known or suspected allergy to the insulin or any compositional component
boolean
C0571622 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0571622 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0021641 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
C0750491 (UMLS CUI [4,4])
Pharmaceutical Preparation Interferes with Glucose metabolism | Systemic Corticosteroid Therapy | Prednisone
Item
anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C4053960 (UMLS CUI [2])
C0032952 (UMLS CUI [3])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
any other condition that the investigator feels would interfere with trial participation or evaluation of results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Terminal illness
Item
terminal illness
boolean
C0679247 (UMLS CUI [1])
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