Information:
Fel:
ID
33683
Beskrivning
A Pharmacokinetic and Pharmacodynamic Study to Determine Blood Levels of JNJ-28431754 (Canagliflozin) in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01128985
Länk
https://clinicaltrials.gov/show/NCT01128985
Nyckelord
Versioner (1)
- 2018-12-19 2018-12-19 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
19 december 2018
DOI
För en begäran logga in.
Licens
Creative Commons BY 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Eligibility Diabetes Mellitus, Type 2 NCT01128985
Eligibility Diabetes Mellitus, Type 2 NCT01128985
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT01128985
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
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])
C0205082 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])