ID

44014

Description

A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00477581

Link

https://clinicaltrials.gov/show/NCT00477581

Keywords

Versions (2)
  1. 9/5/17 9/5/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

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.

Back to model comments
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 NCT00477581

English

Eligibility Type 2 Diabetes Mellitus NCT00477581

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
treatment with metformin for at least 2 months
Description

Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0025598
has hba1c 7.0% to 11.0%, inclusive, at screening
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
body mass index (bmi)25 kg/m^2 to 45 kg/m^2, inclusive
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
list of medications that are not allowed or the patient has been on stable treatment for at least 2 months:
Description

Pharmaceutical Preparations Illicit | Therapeutic procedure Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332266
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205360
hormone replacement therapy (female subjects)
Description

Hormone replacement therapy | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C0079399
oral contraceptives (female subjects)
Description

Gender Oral Contraceptives

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0009905
antihypertensive agents
Description

Antihypertensive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0003364
lipid-lowering agents
Description

Antilipemic agent

Data type

boolean

Alias
UMLS CUI [1]
C0086440
thyroid replacement therapy
Description

Thyroid hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C2242640
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has been treated with exenatide (byetta®) or any dpp-4 inhibitor prior to screening
Description

Exenatide | Byetta | Dipeptidyl-Peptidase IV Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2]
C1636686
UMLS CUI [3]
C1827106
received any study medication or participated in any type of clinical trial within 30 days prior to screening
Description

Investigational New Drugs | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
has donated blood within 60 days of screening visit or is planning to donate blood during the study
Description

Blood Donation | Blood Donation Planned

Data type

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1301732
treated with any of the following medications:
Description

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
sulfonylurea or thiazolidinedione within 3 months of screening;
Description

Sulfonylurea | Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C0038766
UMLS CUI [2]
C1257987
alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (symlin®)within 30 days of screening;
Description

alpha-Glucosidase Inhibitors | Meglitinide | nateglinide | Pramlintide | Symlin

Data type

boolean

Alias
UMLS CUI [1]
C1299007
UMLS CUI [2]
C0065880
UMLS CUI [3]
C0903898
UMLS CUI [4]
C0537551
UMLS CUI [5]
C1174780
insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening;
Description

Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0021641
drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and reglan®(metoclopramide);
Description

Pharmaceutical Preparations Affecting Gastrointestinal Motility | Anticholinergic Agents | Macrolide Antibiotics | Dopamine Antagonists | Opioids | Reglan | Metoclopramide

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0017184
UMLS CUI [2]
C0242896
UMLS CUI [3]
C0003240
UMLS CUI [4]
C0242702
UMLS CUI [5]
C0242402
UMLS CUI [6]
C0034977
UMLS CUI [7]
C0025853
systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including advair®) steroids known to have a high rate of systemic absorption;
Description

Systemic steroids Oral | Systemic steroids Intravenous | Systemic steroids Intramuscular | Inhaled steroids | Steroids Intrapulmonary | Advair | Systemic Absorption Rate High

Data type

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C2825233
UMLS CUI [2,2]
C1522726
UMLS CUI [3,1]
C2825233
UMLS CUI [3,2]
C1556154
UMLS CUI [4]
C2065041
UMLS CUI [5,1]
C0038317
UMLS CUI [5,2]
C1522224
UMLS CUI [6]
C0965130
UMLS CUI [7,1]
C3850076
UMLS CUI [7,2]
C1521828
UMLS CUI [7,3]
C0205250
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00477581

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Metformin
Item
treatment with metformin for at least 2 months
boolean
C0025598 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
has hba1c 7.0% to 11.0%, inclusive, at screening
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi)25 kg/m^2 to 45 kg/m^2, inclusive
boolean
C1305855 (UMLS CUI [1])
Pharmaceutical Preparations Illicit | Therapeutic procedure Stable
Item
list of medications that are not allowed or the patient has been on stable treatment for at least 2 months:
boolean
C0013227 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Hormone replacement therapy | Gender
Item
hormone replacement therapy (female subjects)
boolean
C0282402 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Gender Oral Contraceptives
Item
oral contraceptives (female subjects)
boolean
C0079399 (UMLS CUI [1,1])
C0009905 (UMLS CUI [1,2])
Antihypertensive Agents
Item
antihypertensive agents
boolean
C0003364 (UMLS CUI [1])
Antilipemic agent
Item
lipid-lowering agents
boolean
C0086440 (UMLS CUI [1])
Thyroid hormone replacement therapy
Item
thyroid replacement therapy
boolean
C2242640 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Exenatide | Byetta | Dipeptidyl-Peptidase IV Inhibitors
Item
has been treated with exenatide (byetta®) or any dpp-4 inhibitor prior to screening
boolean
C0167117 (UMLS CUI [1])
C1636686 (UMLS CUI [2])
C1827106 (UMLS CUI [3])
Investigational New Drugs | Study Subject Participation Status
Item
received any study medication or participated in any type of clinical trial within 30 days prior to screening
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Blood Donation | Blood Donation Planned
Item
has donated blood within 60 days of screening visit or is planning to donate blood during the study
boolean
C0005794 (UMLS CUI [1])
C0005794 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Pharmaceutical Preparations
Item
treated with any of the following medications:
boolean
C0013227 (UMLS CUI [1])
Sulfonylurea | Thiazolidinediones
Item
sulfonylurea or thiazolidinedione within 3 months of screening;
boolean
C0038766 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
alpha-Glucosidase Inhibitors | Meglitinide | nateglinide | Pramlintide | Symlin
Item
alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (symlin®)within 30 days of screening;
boolean
C1299007 (UMLS CUI [1])
C0065880 (UMLS CUI [2])
C0903898 (UMLS CUI [3])
C0537551 (UMLS CUI [4])
C1174780 (UMLS CUI [5])
Insulin
Item
insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening;
boolean
C0021641 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Gastrointestinal Motility | Anticholinergic Agents | Macrolide Antibiotics | Dopamine Antagonists | Opioids | Reglan | Metoclopramide
Item
drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and reglan®(metoclopramide);
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0017184 (UMLS CUI [1,3])
C0242896 (UMLS CUI [2])
C0003240 (UMLS CUI [3])
C0242702 (UMLS CUI [4])
C0242402 (UMLS CUI [5])
C0034977 (UMLS CUI [6])
C0025853 (UMLS CUI [7])
Systemic steroids Oral | Systemic steroids Intravenous | Systemic steroids Intramuscular | Inhaled steroids | Steroids Intrapulmonary | Advair | Systemic Absorption Rate High
Item
systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including advair®) steroids known to have a high rate of systemic absorption;
boolean
C2825233 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
C2825233 (UMLS CUI [3,1])
C1556154 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4])
C0038317 (UMLS CUI [5,1])
C1522224 (UMLS CUI [5,2])
C0965130 (UMLS CUI [6])
C3850076 (UMLS CUI [7,1])
C1521828 (UMLS CUI [7,2])
C0205250 (UMLS CUI [7,3])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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