ID

29229

Descrição

Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00789191

Link

https://clinicaltrials.gov/show/NCT00789191

Palavras-chave

Versões (1)
  1. 10/03/2018 10/03/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

10 de março de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT00789191

Inglês

Eligibility Diabetes NCT00789191

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00789191
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes for at least 6 months before trial start
Descrição

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treatment with at least 1000 mg metformin per day for at least 3 months
Descrição

Metformin U/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0456683
insulin-naive (short-term insulin treatment of up to 14 days is allowed)
Descrição

Insulin naive | Insulin short-term allowed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
dpp-4 (dipeptidyl peptidase-4) inhibitor naive
Descrição

Dipeptidyl Peptidase-4 Inhibitor naive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3537225
UMLS CUI [1,2]
C0919936
hba1c (glycosylated haemoglobin a1c) between 7.5-10.0% by central laboratory analysis
Descrição

Glucohemoglobin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0202054
bmi (body mass index) lesser than or equal to 45.0 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
able and willing to take one subcutaneous injection every day
Descrição

Subcutaneous Injections Quantity per day Able | Subcutaneous Injections Quantity per day Willing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021499
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0439505
UMLS CUI [1,4]
C0085732
UMLS CUI [2,1]
C0021499
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0439505
UMLS CUI [2,4]
C0600109
able and willing to perform mandatory smpg (self measured plasma glucose) measurements
Descrição

Plasma Glucose Measurement Self Able | Plasma Glucose Measurement Self Willing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0202042
UMLS CUI [1,2]
C0036588
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0202042
UMLS CUI [2,2]
C0036588
UMLS CUI [2,3]
C0600109
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy or intolerance to any of the trial products or related products
Descrição

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

Tipo de dados

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]
C1744706
UMLS CUI [3,2]
C0013230
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0439849
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0750491
UMLS CUI [5,3]
C0013227
UMLS CUI [5,4]
C0439849
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0013227
UMLS CUI [6,3]
C0439849
severe hypertension
Descrição

Hypertension, severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4013784
treatment with thiazolidinedione (tzd) or glp-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
Descrição

Thiazolidinediones | GLP-1 Mimetics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C3273809
cardiac disease, within the last 12 months
Descrição

Heart Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018799
impaired hepatic function
Descrição

Liver Dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086565
impaired renal function
Descrição

Renal Insufficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
proliferative retinopathy or macular oedema requiring acute treatment
Descrição

Proliferative retinopathy Treatment required for | Macular retinal edema Treatment required for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0271051
UMLS CUI [2,2]
C0332121
female of childbearing potential
Descrição

Childbearing Potential

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3831118
known or suspected abuse of alcohol, narcotics or illicit substances
Descrição

Alcohol abuse | Narcotic Abuse | DRUG ABUSE ILLICIT | Alcohol abuse Suspected | Narcotic Abuse Suspected | DRUG ABUSE ILLICIT Suspected

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0524661
UMLS CUI [3]
C0743253
UMLS CUI [4,1]
C0085762
UMLS CUI [4,2]
C0750491
UMLS CUI [5,1]
C0524661
UMLS CUI [5,2]
C0750491
UMLS CUI [6,1]
C0743253
UMLS CUI [6,2]
C0750491
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Similar models

Eligibility Diabetes NCT00789191

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00789191
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for at least 6 months before trial start
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metformin U/day
Item
treatment with at least 1000 mg metformin per day for at least 3 months
boolean
C0025598 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Insulin naive | Insulin short-term allowed
Item
insulin-naive (short-term insulin treatment of up to 14 days is allowed)
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Dipeptidyl Peptidase-4 Inhibitor naive
Item
dpp-4 (dipeptidyl peptidase-4) inhibitor naive
boolean
C3537225 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c (glycosylated haemoglobin a1c) between 7.5-10.0% by central laboratory analysis
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) lesser than or equal to 45.0 kg/m2
boolean
C1305855 (UMLS CUI [1])
Subcutaneous Injections Quantity per day Able | Subcutaneous Injections Quantity per day Willing
Item
able and willing to take one subcutaneous injection every day
boolean
C0021499 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
C0021499 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439505 (UMLS CUI [2,3])
C0600109 (UMLS CUI [2,4])
Plasma Glucose Measurement Self Able | Plasma Glucose Measurement Self Willing
Item
able and willing to perform mandatory smpg (self measured plasma glucose) measurements
boolean
C0202042 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0202042 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Intolerance to Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related | Intolerance to Pharmaceutical Preparations Related
Item
known or suspected allergy or intolerance to any of the 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])
C1744706 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C0439849 (UMLS CUI [5,4])
C1744706 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C0439849 (UMLS CUI [6,3])
Hypertension, severe
Item
severe hypertension
boolean
C4013784 (UMLS CUI [1])
Thiazolidinediones | GLP-1 Mimetics
Item
treatment with thiazolidinedione (tzd) or glp-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
boolean
C1257987 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
Heart Disease
Item
cardiac disease, within the last 12 months
boolean
C0018799 (UMLS CUI [1])
Liver Dysfunction
Item
impaired hepatic function
boolean
C0086565 (UMLS CUI [1])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Proliferative retinopathy Treatment required for | Macular retinal edema Treatment required for
Item
proliferative retinopathy or macular oedema requiring acute treatment
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0271051 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Childbearing Potential
Item
female of childbearing potential
boolean
C3831118 (UMLS CUI [1])
Alcohol abuse | Narcotic Abuse | DRUG ABUSE ILLICIT | Alcohol abuse Suspected | Narcotic Abuse Suspected | DRUG ABUSE ILLICIT Suspected
Item
known or suspected abuse of alcohol, narcotics or illicit substances
boolean
C0085762 (UMLS CUI [1])
C0524661 (UMLS CUI [2])
C0743253 (UMLS CUI [3])
C0085762 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0524661 (UMLS CUI [5,1])
C0750491 (UMLS CUI [5,2])
C0743253 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
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