ID

17219

Beschrijving

A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00517283

Link

https://clinicaltrials.gov/show/NCT00517283

Trefwoorden

  1. 01-09-16 01-09-16 -
Geüploaded op

1 september 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT00517283

Eligibility Type 2 Diabetes Mellitus NCT00517283

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with at least 1 year history of type 2 diabetes mellitus.
Beschrijving

Type 2 diabetes mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
subjects controlled by oral antidiabetic agents or diet and exercise demonstrated by a screening hba1c ≥7.0% and ≤10.0%.
Beschrijving

HbA1C

Datatype

boolean

Alias
UMLS CUI [1]
C0202054
between the body mass index (bmi) of 19 kg/m2 and 40 kg/m2, inclusive.
Beschrijving

BMI

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
within 4 months of the initial dose of study drug, have received a drug that has not received regulatory approval for any indication.
Beschrijving

Investigational Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
persons who have previously completed or withdrawn from this study or any other study investigating exenatide.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
subjects who are using drugs that significantly affect gastrointestinal motility (including acarbose, metoclopramide, and macrolide antibiotics).
Beschrijving

drugs affecting gastrointestinal motility

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0017184
subjects who intend to start new concomitant medication during the study, including over-the counter medication, apart from occasional intake of paracetamol or vitamin/mineral supplements. anti-emetic medication may be permitted at the investigator's discretion, except those that affect gastrointestinal motility.
Beschrijving

Concomitant medication

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
subjects who have used insulin for more than 4 weeks within 3 months prior to screening.
Beschrijving

Insulin

Datatype

boolean

Alias
UMLS CUI [1]
C0021641
blood donation of more than 500 ml in the last 3 months of screening or any blood donation within the last month.
Beschrijving

blood donation

Datatype

boolean

Alias
UMLS CUI [1]
C0005794

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00517283

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Type 2 diabetes mellitus
Item
subjects with at least 1 year history of type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
HbA1C
Item
subjects controlled by oral antidiabetic agents or diet and exercise demonstrated by a screening hba1c ≥7.0% and ≤10.0%.
boolean
C0202054 (UMLS CUI [1])
BMI
Item
between the body mass index (bmi) of 19 kg/m2 and 40 kg/m2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational Drugs
Item
within 4 months of the initial dose of study drug, have received a drug that has not received regulatory approval for any indication.
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status
Item
persons who have previously completed or withdrawn from this study or any other study investigating exenatide.
boolean
C2348568 (UMLS CUI [1])
drugs affecting gastrointestinal motility
Item
subjects who are using drugs that significantly affect gastrointestinal motility (including acarbose, metoclopramide, and macrolide antibiotics).
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0017184 (UMLS CUI [1,3])
Concomitant medication
Item
subjects who intend to start new concomitant medication during the study, including over-the counter medication, apart from occasional intake of paracetamol or vitamin/mineral supplements. anti-emetic medication may be permitted at the investigator's discretion, except those that affect gastrointestinal motility.
boolean
C2347852 (UMLS CUI [1])
Insulin
Item
subjects who have used insulin for more than 4 weeks within 3 months prior to screening.
boolean
C0021641 (UMLS CUI [1])
blood donation
Item
blood donation of more than 500 ml in the last 3 months of screening or any blood donation within the last month.
boolean
C0005794 (UMLS CUI [1])

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