ID

37383

Beschrijving

Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02081118

Link

https://clinicaltrials.gov/show/NCT02081118

Trefwoorden

  1. 21-07-19 21-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 juli 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT02081118

Eligibility Type 2 Diabetes NCT02081118

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
ages eligible for study : 18 years to 74 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
genders eligible for study : male and female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
diagnosed with t2dm
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
taking a stable dose of metformin monotherapy
Beschrijving

Metformin Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
hba1c levels of between ≥ 7.0% and ≤ 10.0%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
females of childbearing potential who are not pregnant and agree to use a reliable method of birth control
Beschrijving

Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
written informed consent must be obtained
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing (lactating) women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
diagnosis of type 1 diabetes mellitus
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
uncontrolled diabetes defined as a fpg level of > 240 mg/dl at screening
Beschrijving

Diabetic - poor control | Plasma fasting glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0583513
a significant change in body weight in the 3 months before screening
Beschrijving

Body Weight Change

Datatype

boolean

Alias
UMLS CUI [1]
C0005911
any history of gi intolerance
Beschrijving

intolerance gastrointestinal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231199
UMLS CUI [1,2]
C0521362
personal or family history of medullary thyroid cancer (mtc) or a genetic condition that predisposes to mtc
Beschrijving

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Genetic Predisposition Medullary carcinoma of thyroid

Datatype

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0314657
UMLS CUI [3,2]
C0238462
known history of acute or chronic pancreatitis
Beschrijving

Pancreatitis | Pancreatitis, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
a history of alcohol or drug abuse or drug addiction
Beschrijving

Substance Use Disorders | Drug Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C1510472

Similar models

Eligibility Type 2 Diabetes NCT02081118

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
ages eligible for study : 18 years to 74 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
genders eligible for study : male and female
boolean
C0079399 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with t2dm
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Stable
Item
taking a stable dose of metformin monotherapy
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
hba1c levels of between ≥ 7.0% and ≤ 10.0%
boolean
C0474680 (UMLS CUI [1])
Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods
Item
females of childbearing potential who are not pregnant and agree to use a reliable method of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent must be obtained
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
diagnosis of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Diabetic - poor control | Plasma fasting glucose measurement
Item
uncontrolled diabetes defined as a fpg level of > 240 mg/dl at screening
boolean
C0421258 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
Body Weight Change
Item
a significant change in body weight in the 3 months before screening
boolean
C0005911 (UMLS CUI [1])
intolerance gastrointestinal
Item
any history of gi intolerance
boolean
C0231199 (UMLS CUI [1,1])
C0521362 (UMLS CUI [1,2])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Genetic Predisposition Medullary carcinoma of thyroid
Item
personal or family history of medullary thyroid cancer (mtc) or a genetic condition that predisposes to mtc
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0314657 (UMLS CUI [3,1])
C0238462 (UMLS CUI [3,2])
Pancreatitis | Pancreatitis, Chronic
Item
known history of acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Substance Use Disorders | Drug Dependence
Item
a history of alcohol or drug abuse or drug addiction
boolean
C0038586 (UMLS CUI [1])
C1510472 (UMLS CUI [2])

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