ID

20670

Descrição

Insulin Glulisine in Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00360698

Link

https://clinicaltrials.gov/show/NCT00360698

Palavras-chave

Versões (1)
  1. 09/03/2017 09/03/2017 -
Transferido a

9 de março de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00360698

Inglês

Eligibility Diabetes Mellitus, Type 2 NCT00360698

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetes mellitus, type 2
Descrição

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
25 < bmi < 45 kg/m²
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
7,5% < hba1c < 9%
Descrição

Glycosylated hemoglobin A Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
treated with a basal insulin (nph, insulin zinc, insulin glargine or insulin detemir), and at least 1g metformin daily, for more than 3 months
Descrição

Basal insulin | insulin, isophane | Insulin, Lente | Insulin Glargine | insulin detemir | Metformin U/day

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0650607
UMLS CUI [2]
C0021658
UMLS CUI [3]
C0021659
UMLS CUI [4]
C0907402
UMLS CUI [5]
C0537270
UMLS CUI [6,1]
C0025598
UMLS CUI [6,2]
C0456683
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus
Descrição

Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
treatment with oads only
Descrição

Antidiabetics Oral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
treatment with thiazolidinediones, with exenatide or with pramlintide
Descrição

Thiazolidinediones | exenatide | Pramlintide

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0167117
UMLS CUI [3]
C0537551
treatment with an insulin other than basal insulin (premix, rapid insulin, fast-acting insulin analogue)
Descrição

Insulin | Basal insulin | premixed insulin | Insulin, Short-Acting | Insulins and analogues for injection, fast-acting

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0650607
UMLS CUI [3]
C2069057
UMLS CUI [4]
C0356365
UMLS CUI [5]
C3653577
active proliferative diabetic retinopathy,
Descrição

Proliferative diabetic retinopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0154830
pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
Descrição

Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
breast-feeding
Descrição

Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006147
history of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
Descrição

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar

Tipo de dados

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]
C0220807
UMLS CUI [2,4]
C2348205
treatment with systemic corticosteroids in the 3 months prior to study entry
Descrição

CORTICOSTEROIDS FOR SYSTEMIC USE

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3653708
treatment with any investigational product in the 2 months prior to study entry
Descrição

Investigational New Drugs | Investigational Medical Device

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
previous treatment with insulin glulisine
Descrição

Insulin Glulisine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1313386
likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
Descrição

Probability Illicit drug use Patient need for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0033204
UMLS CUI [1,2]
C0281875
UMLS CUI [1,3]
C0686904
clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
Descrição

Cardiovascular Disease | Liver disease | nervous system disorder | Endocrine System Diseases | Disease Major Difficulty with Protocol Compliance | Disease Major Difficulty with research results

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0014130
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205164
UMLS CUI [5,3]
C0332218
UMLS CUI [5,4]
C0525058
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C0205164
UMLS CUI [6,3]
C0332218
UMLS CUI [6,4]
C0683954
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
history of drug or alcohol abuse
Descrição

Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038586
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00360698

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes mellitus, type 2
boolean
C0011860 (UMLS CUI [1])
Body mass index
Item
25 < bmi < 45 kg/m²
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
7,5% < hba1c < 9%
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Basal insulin | insulin, isophane | Insulin, Lente | Insulin Glargine | insulin detemir | Metformin U/day
Item
treated with a basal insulin (nph, insulin zinc, insulin glargine or insulin detemir), and at least 1g metformin daily, for more than 3 months
boolean
C0650607 (UMLS CUI [1])
C0021658 (UMLS CUI [2])
C0021659 (UMLS CUI [3])
C0907402 (UMLS CUI [4])
C0537270 (UMLS CUI [5])
C0025598 (UMLS CUI [6,1])
C0456683 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Antidiabetics Oral
Item
treatment with oads only
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Thiazolidinediones | exenatide | Pramlintide
Item
treatment with thiazolidinediones, with exenatide or with pramlintide
boolean
C1257987 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C0537551 (UMLS CUI [3])
Insulin | Basal insulin | premixed insulin | Insulin, Short-Acting | Insulins and analogues for injection, fast-acting
Item
treatment with an insulin other than basal insulin (premix, rapid insulin, fast-acting insulin analogue)
boolean
C0021641 (UMLS CUI [1])
C0650607 (UMLS CUI [2])
C2069057 (UMLS CUI [3])
C0356365 (UMLS CUI [4])
C3653577 (UMLS CUI [5])
Proliferative diabetic retinopathy
Item
active proliferative diabetic retinopathy,
boolean
C0154830 (UMLS CUI [1])
Pregnancy | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Breast Feeding
Item
breast-feeding
boolean
C0006147 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar
Item
history of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
treatment with systemic corticosteroids in the 3 months prior to study entry
boolean
C3653708 (UMLS CUI [1])
Investigational New Drugs | Investigational Medical Device
Item
treatment with any investigational product in the 2 months prior to study entry
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Insulin Glulisine
Item
previous treatment with insulin glulisine
boolean
C1313386 (UMLS CUI [1])
Probability Illicit drug use Patient need for
Item
likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
boolean
C0033204 (UMLS CUI [1,1])
C0281875 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
Cardiovascular Disease | Liver disease | nervous system disorder | Endocrine System Diseases | Disease Major Difficulty with Protocol Compliance | Disease Major Difficulty with research results
Item
clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C0332218 (UMLS CUI [5,3])
C0525058 (UMLS CUI [5,4])
C0012634 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0332218 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
Liver Dysfunction
Item
impaired hepatic function
boolean
C0086565 (UMLS CUI [1])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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