ID

12773

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01472367

Trefwoorden

  1. 21-12-15 21-12-15 -
Geüploaded op

21 december 2015

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 2 NCT01472367

Eligibility Diabetes Mellitus, Type 2 NCT01472367

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
has type 2 diabetes mellitus (t2dm)
Beschrijving

diabetes mellitus Type 2

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441730
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.
Beschrijving

metformin; insulin; Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0019018
between 10 and 17 years of age on day of signing informed consent with randomization to occur prior to 18th birthday.
Beschrijving

age; informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
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).
Beschrijving

participation family member

Datatype

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0086282
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known type 1 diabetes mellitus or documented evidence of positive diabetes auto-antibodies (if performed when participant was diagnosed with diabetes).
Beschrijving

diabetes mellitusType 1

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441729
known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
Beschrijving

comorbidity

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent.
Beschrijving

hyperglycemia; ketonuria

Datatype

boolean

Alias
UMLS CUI [1]
C0020456
UMLS CUI [2]
C0162275
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).
Beschrijving

Dipeptidyl-Peptidase IV Inhibitors; GLP-1 Receptor Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C1827106
UMLS CUI [2]
C2917359
exhibits abnormal growth patterns or is being treated with growth hormone.
Beschrijving

growth hormone treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0744483
history of idiopathic acute pancreatitis or chronic pancreatitis.
Beschrijving

idiopathic acute pancreatitis; Pancreatitis, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0341461
UMLS CUI [2]
C0149521

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01472367

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
diabetes mellitus Type 2
Item
has type 2 diabetes mellitus (t2dm)
boolean
C0011849 (UMLS CUI [1,1])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])

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