Information:
Fel:
ID
35752
Beskrivning
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02000700
Länk
https://clinicaltrials.gov/show/NCT02000700
Nyckelord
Versioner (1)
- 2019-03-20 2019-03-20 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
20 mars 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02000700
Eligibility Diabetes Mellitus, Type 2 NCT02000700
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT02000700
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Metformin IR Stable U/day
Item
be on a stable regimen of metformin immediate release (ir) monotherapy of at least 1,000 mg/day for at least 8 weeks before screening
boolean
C0025598 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C1708470 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Ability to swallow Tablets
Item
able to swallow whole tablets
boolean
C0566355 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
Autoimmunity Pancreatic Absent
Item
absence of pancreatic autoimmunity
boolean
C0004368 (UMLS CUI [1,1])
C0030274 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0030274 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Agreement Fasting fingerstick blood glucose measurement Self Monitoring
Item
participants and their caregivers must agree to perform the fasting fingerstick glucose self-monitoring during the study
boolean
C0680240 (UMLS CUI [1,1])
C2317664 (UMLS CUI [1,2])
C0588436 (UMLS CUI [1,3])
C2317664 (UMLS CUI [1,2])
C0588436 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
history of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Maturity onset diabetes mellitus in young | Secondary diabetes mellitus
Item
history of maturity onset diabetes of the young (mody) and any secondary form of diabetes
boolean
C0342276 (UMLS CUI [1])
C0271640 (UMLS CUI [2])
C0271640 (UMLS CUI [2])
Illness Clinical Significance | Lung disease | Renal Insufficiency | Hepatic Insufficiency | Thyroid Disease Uncontrolled
Item
current clinically significant medical illness e.g., significant pulmonary disease, renal or hepatic insufficiency, uncontrolled thyroid disease
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C1306571 (UMLS CUI [4])
C0040128 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C2826293 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C1306571 (UMLS CUI [4])
C0040128 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
Abnormal systolic arterial pressure | Abnormal diastolic arterial pressure | Gender | Age | Body Height
Item
systolic or diastolic blood pressure outside the range considered normal for the participant sex, age and height
boolean
C0277883 (UMLS CUI [1])
C0277888 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0005890 (UMLS CUI [5])
C0277888 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0005890 (UMLS CUI [5])
Pregnancy
Item
for females, participants will be excluded if pregnant
boolean
C0032961 (UMLS CUI [1])