Information:
Fel:
ID
12773
Beskrivning
A Study of the Safety and Efficacy of MK-0431A in Pediatric Participants With Type 2 Diabetes Mellitus (MK-0431A-170); ODM derived from: https://clinicaltrials.gov/show/NCT01472367
Länk
https://clinicaltrials.gov/show/NCT01472367
Nyckelord
Versioner (1)
- 2015-12-21 2015-12-21 -
Uppladdad den
21 december 2015
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01472367
Eligibility Diabetes Mellitus, Type 2 NCT01472367
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus, Type 2 NCT01472367
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
diabetes mellitus Type 2
Item
has type 2 diabetes mellitus (t2dm)
boolean
C0011849 (UMLS CUI [1,1])
C0441730 (UMLS CUI [1,2])
C0441730 (UMLS CUI [1,2])
metformin; insulin; Glycosylated hemoglobin A
Item
is on metformin monotherapy (≥1500 mg/day) for ≥12 weeks with a1c ≥6.5% and ≤10.0% or is on stable doses of metformin (≥1500 mg/day) and insulin for ≥12 weeks with an a1c ≥7.0% and ≤10%. note: participants on a daily dose of metformin greater than or equal to 1000 mg/day, but less than 1500 mg/day may be eligible if there is documentation that higher doses are not tolerated.
boolean
C0025598 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0019018 (UMLS CUI [3])
C0021641 (UMLS CUI [2])
C0019018 (UMLS CUI [3])
age; informed consent
Item
between 10 and 17 years of age on day of signing informed consent with randomization to occur prior to 18th birthday.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0021430 (UMLS CUI [2])
participation family member
Item
participant and a family member or adult closely involved in the daily activities will participate in the participant's treatment and study protocol (i.e., available for telephone calls, study visits and administration of study medication as needed).
boolean
C0679823 (UMLS CUI [1,1])
C0086282 (UMLS CUI [1,2])
C0086282 (UMLS CUI [1,2])
diabetes mellitusType 1
Item
known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when participant was diagnosed with diabetes).
boolean
C0011849 (UMLS CUI [1,1])
C0441729 (UMLS CUI [1,2])
C0441729 (UMLS CUI [1,2])
comorbidity
Item
known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
boolean
C0009488 (UMLS CUI [1])
hyperglycemia; ketonuria
Item
symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent.
boolean
C0020456 (UMLS CUI [1])
C0162275 (UMLS CUI [2])
C0162275 (UMLS CUI [2])
Dipeptidyl-Peptidase IV Inhibitors; GLP-1 Receptor Agonist
Item
participant has previously taken a dipeptidyl peptidase-iv (dpp-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or glucagon-like peptide-1 (glp-1) receptor agonist (such as exenatide or liraglutide).
boolean
C1827106 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
C2917359 (UMLS CUI [2])
growth hormone treatment
Item
exhibits abnormal growth patterns or is being treated with growth hormone.
boolean
C0744483 (UMLS CUI [1])
idiopathic acute pancreatitis; Pancreatitis, Chronic
Item
history of idiopathic acute pancreatitis or chronic pancreatitis.
boolean
C0341461 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
C0149521 (UMLS CUI [2])