ID

44014

Descrição

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

Palavras-chave

Versões (2)
  1. 05/09/2017 05/09/2017 -
  2. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00477581

Inglês

Eligibility Type 2 Diabetes Mellitus NCT00477581

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Metformin

Tipo de dados

boolean

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

Glycosylated hemoglobin A

Tipo de dados

boolean

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

Body mass index

Tipo de dados

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:
Descrição

Pharmaceutical Preparations Illicit | Therapeutic procedure Stable

Tipo de dados

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)
Descrição

Hormone replacement therapy | Gender

Tipo de dados

boolean

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

Gender Oral Contraceptives

Tipo de dados

boolean

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

Antihypertensive Agents

Tipo de dados

boolean

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

Antilipemic agent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086440
thyroid replacement therapy
Descrição

Thyroid hormone replacement therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2242640
Exclusion Criteria
Descrição

Exclusion Criteria

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

Exenatide | Byetta | Dipeptidyl-Peptidase IV Inhibitors

Tipo de dados

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
Descrição

Investigational New Drugs | Study Subject Participation Status

Tipo de dados

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
Descrição

Blood Donation | Blood Donation Planned

Tipo de dados

boolean

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

Pharmaceutical Preparations

Tipo de dados

boolean

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

Sulfonylurea | Thiazolidinediones

Tipo de dados

boolean

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

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

Tipo de dados

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;
Descrição

Insulin

Tipo de dados

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);
Descrição

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

Tipo de dados

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;
Descrição

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

Tipo de dados

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
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Eligibility Type 2 Diabetes Mellitus NCT00477581

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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