ID

23252

Description

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

Keywords

  1. 6/30/17 6/30/17 -
Uploaded on

June 30, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes Mellitus NCT00382239

Eligibility Type 2 Diabetes Mellitus NCT00382239

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes.
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

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

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Description

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.
Description

Drugs, Non-Prescription

Data type

boolean

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

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

Data type

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.
Description

Insulin Exogenous

Data type

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®
Description

Pharmaceutical Preparations Affecting Gastrointestinal Motility | Nauzelin | Domperidone | Primperan

Data type

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).
Description

Metoclopramide | itopride | Cisapride | mosapride | Trimebutine

Data type

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.
Description

Medical contraindication Pharmaceutical Preparations

Data type

boolean

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

Drug Allergy Severe

Data type

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)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial