ID

23252

Beschrijving

A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00382239

Link

https://clinicaltrials.gov/show/NCT00382239

Trefwoorden

  1. 30-06-17 30-06-17 -
Geüploaded op

30 juni 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT00382239

Eligibility Type 2 Diabetes Mellitus NCT00382239

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes.
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
have a body weight of >=50 kg.
Beschrijving

Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Beschrijving

Drugs, Non-Prescription

Datatype

boolean

Alias
UMLS CUI [1]
C0013231
have participated in this study previously, or any other study using exenatide or other glp-1 analogs.
Beschrijving

Study Subject Participation Status | exenatide | Glucagon-Like Peptide 1 Analog

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0167117
UMLS CUI [3,1]
C0061355
UMLS CUI [3,2]
C0243071
are treated with any exogenous insulin within 3 months of screening.
Beschrijving

Insulin Exogenous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0205228
are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *drugs that directly affect gastrointestinal motility, including nauzelin® (domperidone), primperan®/terperan®
Beschrijving

Pharmaceutical Preparations Affecting Gastrointestinal Motility | Nauzelin | Domperidone | Primperan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0017184
UMLS CUI [2]
C1579773
UMLS CUI [3]
C0013015
UMLS CUI [4]
C0242395
(metoclopramide), ganaton® (itopride), acenalin® (cisapride), gasmotin® (mosapride), or cerekinon® (trimebutine).
Beschrijving

Metoclopramide | itopride | Cisapride | mosapride | Trimebutine

Datatype

boolean

Alias
UMLS CUI [1]
C0025853
UMLS CUI [2]
C0531483
UMLS CUI [3]
C0072916
UMLS CUI [4]
C0526501
UMLS CUI [5]
C0041023
have characteristics contraindicating for concomitant medication, according to product-specific label.
Beschrijving

Medical contraindication Pharmaceutical Preparations

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013227
have severe allergy or hypersensitivity to any drug.
Beschrijving

Drug Allergy Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013182
UMLS CUI [1,2]
C0205082

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00382239

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Body Weight
Item
have a body weight of >=50 kg.
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Drugs, Non-Prescription
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C0013231 (UMLS CUI [1])
Study Subject Participation Status | exenatide | Glucagon-Like Peptide 1 Analog
Item
have participated in this study previously, or any other study using exenatide or other glp-1 analogs.
boolean
C2348568 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C0061355 (UMLS CUI [3,1])
C0243071 (UMLS CUI [3,2])
Insulin Exogenous
Item
are treated with any exogenous insulin within 3 months of screening.
boolean
C0021641 (UMLS CUI [1,1])
C0205228 (UMLS CUI [1,2])
Pharmaceutical Preparations Affecting Gastrointestinal Motility | Nauzelin | Domperidone | Primperan
Item
are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *drugs that directly affect gastrointestinal motility, including nauzelin® (domperidone), primperan®/terperan®
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0017184 (UMLS CUI [1,3])
C1579773 (UMLS CUI [2])
C0013015 (UMLS CUI [3])
C0242395 (UMLS CUI [4])
Metoclopramide | itopride | Cisapride | mosapride | Trimebutine
Item
(metoclopramide), ganaton® (itopride), acenalin® (cisapride), gasmotin® (mosapride), or cerekinon® (trimebutine).
boolean
C0025853 (UMLS CUI [1])
C0531483 (UMLS CUI [2])
C0072916 (UMLS CUI [3])
C0526501 (UMLS CUI [4])
C0041023 (UMLS CUI [5])
Medical contraindication Pharmaceutical Preparations
Item
have characteristics contraindicating for concomitant medication, according to product-specific label.
boolean
C1301624 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Drug Allergy Severe
Item
have severe allergy or hypersensitivity to any drug.
boolean
C0013182 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])

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