ID

17305

Descripción

Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00605020

Link

https://clinicaltrials.gov/show/NCT00605020

Palabras clave

Versiones (1)
  1. 6/9/16 6/9/16 -
Subido en

6 de septiembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT00605020

Inglés

Eligibility Diabetes NCT00605020

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00605020
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
duration of type 2 diabetes for at least 6 months since diagnosis
Descripción

Non-Insulin-Dependent Diabetes Mellitus disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
Descripción

Oral hypoglycemic Quantity | Intermediate-acting insulin U/day | Long-Acting Insulin U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0304869
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0304870
UMLS CUI [3,2]
C0456683
bmi below 40 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
hba1c between 7-12%
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
able and willing to perform self-monitoring of capillary blood glucose
Descripción

Self Monitoring Capillary blood glucose measurement Willing

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0588436
UMLS CUI [1,2]
C0457578
UMLS CUI [1,3]
C0600109
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
current antidiabetic treatment with combination of three or more oral antidiabetic drugs
Descripción

Oral hypoglycemic Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C1265611
previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
Descripción

Insulin, Short-Acting | Biphasic Insulins

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0356365
UMLS CUI [2]
C0356369
known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator
Descripción

Loss of hypoglycemic warning | Recurrent severe hypoglycemia

Tipo de datos

boolean

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

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0013230
pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0205412
receipt of any investigational drug within 4 weeks prior to this trial
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
previous participation in this trial
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Diabetes NCT00605020

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00605020
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
duration of type 2 diabetes for at least 6 months since diagnosis
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Oral hypoglycemic Quantity | Intermediate-acting insulin U/day | Long-Acting Insulin U/day
Item
current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0304869 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0304870 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
Body mass index
Item
bmi below 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c between 7-12%
boolean
C0019018 (UMLS CUI [1])
Self Monitoring Capillary blood glucose measurement Willing
Item
able and willing to perform self-monitoring of capillary blood glucose
boolean
C0588436 (UMLS CUI [1,1])
C0457578 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Oral hypoglycemic Quantity
Item
current antidiabetic treatment with combination of three or more oral antidiabetic drugs
boolean
C0359086 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Insulin, Short-Acting | Biphasic Insulins
Item
previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
boolean
C0356365 (UMLS CUI [1])
C0356369 (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 Pharmaceutical Preparations Related Investigational New Drugs
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Inadequate
Item
pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
Investigational New Drugs
Item
receipt of any investigational drug within 4 weeks prior to this trial
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status
Item
previous participation in this trial
boolean
C2348568 (UMLS CUI [1])
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