Anglais

Eligibility Diabetes Mellitus, Type 2 NCT01128985

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients must have a diagnosis of t2dm for at least 1 year, but not more than 12 years prior to day -1 of the study and be medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and electrocardiogram (ecg) performed at screening
Description

Non-Insulin-Dependent Diabetes Mellitus Stable Disease length | Physical Examination | Medical History | Safety Laboratory Results | Vital signs | ECG

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0872146
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0262926
UMLS CUI [4,1]
C0036043
UMLS CUI [4,2]
C1254595
UMLS CUI [5]
C0518766
UMLS CUI [6]
C0013798
patients must be on generally stable approved anti-hypeglycemic agent (aha) regimen (i.e., with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to the screening visit
Description

Hypoglycemic Agents Stable | Change of medication Absent | Dosage Change Step Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0580105
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C1261552
UMLS CUI [3,4]
C1265611
patients must have fasting plasma glucose (fpg) concentrations between 7.8 mm (140 mg/dl) and 15 mm (270 mg/dl) on day -2
Description

Plasma fasting glucose measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of clinically significant diabetic complications including retinopathy, nephropathy, or macro albuminuria, neuropathy, gastroparesis, or diabetic ketoacidosis
Description

Complications of Diabetes Mellitus | Retinal Diseases | Kidney Diseases | High urine albumin levels | Neuropathy | Gastroparesis | Diabetic Ketoacidosis

Type de données

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0035309
UMLS CUI [3]
C0022658
UMLS CUI [4]
C1654921
UMLS CUI [5]
C0442874
UMLS CUI [6]
C0152020
UMLS CUI [7]
C0011880
history of type 1 diabetes mellitus (t1dm)
Description

Diabetes Mellitus, Insulin-Dependent

Type de données

boolean

Alias
UMLS CUI [1]
C0011854
history of repeated severe hypoglycemic episodes before screening
Description

Hypoglycaemic episode Severe Repeated

Type de données

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205341
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01128985

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Stable Disease length | Physical Examination | Medical History | Safety Laboratory Results | Vital signs | ECG
Item
all patients must have a diagnosis of t2dm for at least 1 year, but not more than 12 years prior to day -1 of the study and be medically stable on the basis of physical examination, medical history, laboratory safety test results, vital signs and electrocardiogram (ecg) performed at screening
boolean
C0011860 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0036043 (UMLS CUI [4,1])
C1254595 (UMLS CUI [4,2])
C0518766 (UMLS CUI [5])
C0013798 (UMLS CUI [6])
Hypoglycemic Agents Stable | Change of medication Absent | Dosage Change Step Quantity
Item
patients must be on generally stable approved anti-hypeglycemic agent (aha) regimen (i.e., with no change in medication, or only 1 dose step change in dose) for at least 2 months prior to the screening visit
boolean
C0020616 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0580105 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0178602 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C1261552 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Plasma fasting glucose measurement
Item
patients must have fasting plasma glucose (fpg) concentrations between 7.8 mm (140 mg/dl) and 15 mm (270 mg/dl) on day -2
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Complications of Diabetes Mellitus | Retinal Diseases | Kidney Diseases | High urine albumin levels | Neuropathy | Gastroparesis | Diabetic Ketoacidosis
Item
history of clinically significant diabetic complications including retinopathy, nephropathy, or macro albuminuria, neuropathy, gastroparesis, or diabetic ketoacidosis
boolean
C0342257 (UMLS CUI [1])
C0035309 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C1654921 (UMLS CUI [4])
C0442874 (UMLS CUI [5])
C0152020 (UMLS CUI [6])
C0011880 (UMLS CUI [7])
Diabetes Mellitus, Insulin-Dependent
Item
history of type 1 diabetes mellitus (t1dm)
boolean
C0011854 (UMLS CUI [1])
Hypoglycaemic episode Severe Repeated
Item
history of repeated severe hypoglycemic episodes before screening
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
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