ID

29120

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00663884

Trefwoorden

Versies (1)
  1. 26-02-18 26-02-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

26 februari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00663884

Engels

Eligibility Diabetes Mellitus, Type 2 NCT00663884

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Diabetes Mellitus, Non-Insulin-Dependent | Age

Datatype

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
Beschrijving

Glucohemoglobin measurement | Antidiabetics Oral Quantity | Insulin Glargine

Datatype

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/㎡
Beschrijving

Outpatients | Body mass index

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Insulin Formulation | Exception Insulin Glargine

Datatype

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
Beschrijving

Fasting blood glucose measurement

Datatype

boolean

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

Insulin C-peptide measurement Stomach empty

Datatype

boolean

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

Gastrointestinal Surgical Procedure

Datatype

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
Beschrijving

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

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Angina, Unstable | Myocardial Infarction

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Life threatening illness | Malignant Neoplasms | Communicable Disease Severe

Datatype

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
Beschrijving

Drug Allergy

Datatype

boolean

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

Pregnancy | Breast Feeding | Pregnancy likely

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Study Subject Participation Status Unsuitable for other reasons

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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