ID

29120

Descrição

Glufast On Insulin Glargine Trial in Type 2 DM; ODM derived from: https://clinicaltrials.gov/show/NCT00663884

Link

https://clinicaltrials.gov/show/NCT00663884

Palavras-chave

Versões (1)
  1. 26/02/2018 26/02/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de fevereiro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00663884

Inglês

Eligibility Diabetes Mellitus, Type 2 NCT00663884

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
the type 2 diabetic patients aged between 30 and 70
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0001779
the patients whose hb1ac is over 7.0% despite administration of two or more oral antidiabetic drugs over 6 months or only insulin glargine over 3 months before registration
Descrição

Glucohemoglobin measurement | Antidiabetics Oral Quantity | Insulin Glargine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0907402
outpatients whose bmi is between 21 and 40 kg/㎡
Descrição

Outpatients | Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C1305855
the patients who consented to participate in the clinical study in writing
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patients who have been using insulin formulation except insulin glargine
Descrição

Insulin Formulation | Exception Insulin Glargine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0524527
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0907402
the patients whose fasting blood glucose is over 270 mg/dl
Descrição

Fasting blood glucose measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428568
the patients whose c-peptide is under 1ng/ml on an empty stomach
Descrição

Insulin C-peptide measurement Stomach empty

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0202100
UMLS CUI [1,2]
C3686898
the patients who was surgically operated of gastrointestinal tract
Descrição

Gastrointestinal Surgical Procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524722
the patients who need additional treatment or who underwent operation within 3 months for severe complication such as diabetic foot ulcer, retinopathy and neuropathy
Descrição

Additional Therapy Severe complication | Operative Surgical Procedures Severe complication | Diabetic foot ulcer | Retinal Disease | Neuropathy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1706712
UMLS CUI [1,2]
C3495031
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C3495031
UMLS CUI [3]
C1456868
UMLS CUI [4]
C0035309
UMLS CUI [5]
C0442874
the patients with severe hepatic dysfunction : uncompensated hepatic cirrhosis, or the case where aspartate aminotransferase (ast) or alanine aminotransferase (alt) is over 2.5 times higher than the normal limit ( ≥ 2.5 x normal ranges)
Descrição

Liver Dysfunction Severe | Liver Cirrhosis Uncompensated | Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0205433
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
the patients with unstable angina or acute myocardial infarction occurred within 3months
Descrição

Angina, Unstable | Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
the patients with renal failure or severe hypertension : diastolic blood pressure is over 110mmhg despite drug treatment
Descrição

Kidney Failure | Hypertension, severe | Diastolic blood pressure | Pharmacotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C4013784
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0013216
the patients who have a life-threatening disease such as cancer or severe infection
Descrição

Life threatening illness | Malignant Neoplasms | Communicable Disease Severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205082
the patients with a history of drug allergy
Descrição

Drug Allergy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013182
pregnant or breast feeding or the women who are likely to be pregnant
Descrição

Pregnancy | Breast Feeding | Pregnancy likely

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750492
the patients who need oral or parenteral corticosteroids
Descrição

Patient need for Adrenal Cortex Hormones Oral | Patient need for Adrenal Cortex Hormones Parenteral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C1527415
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0001617
UMLS CUI [2,3]
C1518896
the patients who were judged to be unsuitable to the clinical study by other reasons
Descrição

Study Subject Participation Status Unsuitable for other reasons

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3844399
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00663884

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Age
Item
the type 2 diabetic patients aged between 30 and 70
boolean
C0011860 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Glucohemoglobin measurement | Antidiabetics Oral Quantity | Insulin Glargine
Item
the patients whose hb1ac is over 7.0% despite administration of two or more oral antidiabetic drugs over 6 months or only insulin glargine over 3 months before registration
boolean
C0202054 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0907402 (UMLS CUI [3])
Outpatients | Body mass index
Item
outpatients whose bmi is between 21 and 40 kg/㎡
boolean
C0029921 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Informed Consent
Item
the patients who consented to participate in the clinical study in writing
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin Formulation | Exception Insulin Glargine
Item
the patients who have been using insulin formulation except insulin glargine
boolean
C0021641 (UMLS CUI [1,1])
C0524527 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
Fasting blood glucose measurement
Item
the patients whose fasting blood glucose is over 270 mg/dl
boolean
C0428568 (UMLS CUI [1])
Insulin C-peptide measurement Stomach empty
Item
the patients whose c-peptide is under 1ng/ml on an empty stomach
boolean
C0202100 (UMLS CUI [1,1])
C3686898 (UMLS CUI [1,2])
Gastrointestinal Surgical Procedure
Item
the patients who was surgically operated of gastrointestinal tract
boolean
C0524722 (UMLS CUI [1])
Additional Therapy Severe complication | Operative Surgical Procedures Severe complication | Diabetic foot ulcer | Retinal Disease | Neuropathy
Item
the patients who need additional treatment or who underwent operation within 3 months for severe complication such as diabetic foot ulcer, retinopathy and neuropathy
boolean
C1706712 (UMLS CUI [1,1])
C3495031 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C3495031 (UMLS CUI [2,2])
C1456868 (UMLS CUI [3])
C0035309 (UMLS CUI [4])
C0442874 (UMLS CUI [5])
Liver Dysfunction Severe | Liver Cirrhosis Uncompensated | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
the patients with severe hepatic dysfunction : uncompensated hepatic cirrhosis, or the case where aspartate aminotransferase (ast) or alanine aminotransferase (alt) is over 2.5 times higher than the normal limit ( ≥ 2.5 x normal ranges)
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0205433 (UMLS CUI [2,2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
Angina, Unstable | Myocardial Infarction
Item
the patients with unstable angina or acute myocardial infarction occurred within 3months
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Kidney Failure | Hypertension, severe | Diastolic blood pressure | Pharmacotherapy
Item
the patients with renal failure or severe hypertension : diastolic blood pressure is over 110mmhg despite drug treatment
boolean
C0035078 (UMLS CUI [1])
C4013784 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0013216 (UMLS CUI [4])
Life threatening illness | Malignant Neoplasms | Communicable Disease Severe
Item
the patients who have a life-threatening disease such as cancer or severe infection
boolean
C3846017 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Drug Allergy
Item
the patients with a history of drug allergy
boolean
C0013182 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy likely
Item
pregnant or breast feeding or the women who are likely to be pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
Patient need for Adrenal Cortex Hormones Oral | Patient need for Adrenal Cortex Hormones Parenteral
Item
the patients who need oral or parenteral corticosteroids
boolean
C0686904 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0001617 (UMLS CUI [2,2])
C1518896 (UMLS CUI [2,3])
Study Subject Participation Status Unsuitable for other reasons
Item
the patients who were judged to be unsuitable to the clinical study by other reasons
boolean
C2348568 (UMLS CUI [1,1])
C3844399 (UMLS CUI [1,2])
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