ID

29226

Beskrivning

Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00698802

Länk

https://clinicaltrials.gov/show/NCT00698802

Nyckelord

Versioner (1)
  1. 2018-03-09 2018-03-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 mars 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT00698802

Engelsk

Eligibility Diabetes NCT00698802

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00698802
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes for at least 12 months
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
current biphasic human insulin (bhi) for at least 3 months - as monotherapy or as the only insulin in combination with oads
Beskrivning

Biphasic Insulins | Antidiabetics Oral | Combined Modality Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0356369
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0009429
body mass index (bmi) less than or equal to 40.0 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
hba1c less than or equal to 9.5%
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
fpg (smpg) less than or equal to 12 mmol/l
Beskrivning

Plasma fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with more than 1iu/kg insulin daily
Beskrivning

Insulin IU/kg Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0439463
UMLS CUI [1,3]
C0332173
treatment with glucagon-like peptide 1 mimetics or dipeptityl peptidase iv inhibitors
Beskrivning

GLP-1 Mimetics | Dipeptidyl Peptidase 4 Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C3273809
UMLS CUI [2]
C2917254
known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator
Beskrivning

Loss of hypoglycemic warning | Recurrent severe hypoglycemia

Datatyp

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2]
C0342316
known or suspected allergy to trial products or related products
Beskrivning

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

Datatyp

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
receipt of any investigational drug within one month prior to this trial
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
any other condition that the investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
Beskrivning

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

Datatyp

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
UMLS CUI [3]
C0425104
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Similar models

Eligibility Diabetes NCT00698802

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00698802
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes for at least 12 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Biphasic Insulins | Antidiabetics Oral | Combined Modality Therapy
Item
current biphasic human insulin (bhi) for at least 3 months - as monotherapy or as the only insulin in combination with oads
boolean
C0356369 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0009429 (UMLS CUI [3])
Body mass index
Item
body mass index (bmi) less than or equal to 40.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c less than or equal to 9.5%
boolean
C0202054 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg (smpg) less than or equal to 12 mmol/l
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin IU/kg Daily
Item
treatment with more than 1iu/kg insulin daily
boolean
C0021641 (UMLS CUI [1,1])
C0439463 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
GLP-1 Mimetics | Dipeptidyl Peptidase 4 Inhibitors
Item
treatment with glucagon-like peptide 1 mimetics or dipeptityl peptidase iv inhibitors
boolean
C3273809 (UMLS CUI [1])
C2917254 (UMLS CUI [2])
Loss of hypoglycemic warning | Recurrent severe hypoglycemia
Item
known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator
boolean
C0342317 (UMLS CUI [1])
C0342316 (UMLS CUI [2])
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])
Investigational New Drugs
Item
receipt of any investigational drug within one month prior to this trial
boolean
C0013230 (UMLS CUI [1])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results | Shift worker
Item
any other condition that the investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
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])
C0425104 (UMLS CUI [3])
Tillbaka till toppen 

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