ID

20839

Descrição

Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00306384

Link

https://clinicaltrials.gov/show/NCT00306384

Palavras-chave

  1. 21/03/2017 21/03/2017 -
Transferido a

21 de março de 2017

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus NCT00306384

Eligibility Diabetes Mellitus NCT00306384

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
Descrição

Gynaecological status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
type 2 diabetes mellitus and was enrolled in one of the following 7 controlled phase iii studies. the study will be open to all patients who completed one of these studies through the end-of-treatment visit:
Descrição

Diabetes mellitus type 2 and study participation status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C2348568
syr-322-plc-010 - nct00286455
Descrição

syr-322-plc-010 - nct00286455

Tipo de dados

boolean

syr-322-sulf-007 - nct00286468
Descrição

syr-322-sulf-007 - nct00286468

Tipo de dados

boolean

syr-322-met-008 - nct00286442
Descrição

syr-322-met-008 - nct00286442

Tipo de dados

boolean

syr-322-tzd-009 - nct00286494
Descrição

syr-322-tzd-009 - nct00286494

Tipo de dados

boolean

syr-322-ins-011 - nct00286429
Descrição

syr-322-ins-011 - nct00286429

Tipo de dados

boolean

01-05-tl-322opi-001 - nct00328627
Descrição

01-05-tl-322opi-001 - nct00328627

Tipo de dados

boolean

01-06-tl-322opi-002 - nct00395512
Descrição

01-06-tl-322opi-002 - nct00395512

Tipo de dados

boolean

alanine aminotransferase less than or equal to 3 times the upper limit of normal and serum creatinine less than or equal to 2.0 mg per dl.
Descrição

alanine aminotransferase and serum creatinine measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201976
able and willing to monitor own blood glucose concentrations with a home glucose monitor.
Descrição

Home glucose monitor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0917953
no major illness or debility that in the investigator's opinion prohibits the patient from completing the study.
Descrição

Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
the occurrence of any adverse event or condition during the controlled phase iii studies, which, in the opinion of the investigator, should exclude the patient from participating in the open-label extension.
Descrição

Adverse event

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0877248
is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Descrição

Pharmacotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013216
weight-loss drugs
Descrição

Weight-loss drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0376606
investigational antidiabetics, additional dipeptidyl peptidase-4 (dpp-4) and glucagon-like peptide-1 (glp 1) inhibitors
Descrição

Investigational antidiabetics

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0304229
incretin mimetics,
Descrição

Incretin mimetics

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3839883
oral or systemically injected glucocorticoids.
Descrição

Glucocorticoids

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0017710

Similar models

Eligibility Diabetes Mellitus NCT00306384

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gynaecological status
Item
females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Diabetes mellitus type 2 and study participation status
Item
type 2 diabetes mellitus and was enrolled in one of the following 7 controlled phase iii studies. the study will be open to all patients who completed one of these studies through the end-of-treatment visit:
boolean
C0011860 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
syr-322-plc-010 - nct00286455
Item
syr-322-plc-010 - nct00286455
boolean
syr-322-sulf-007 - nct00286468
Item
syr-322-sulf-007 - nct00286468
boolean
syr-322-met-008 - nct00286442
Item
syr-322-met-008 - nct00286442
boolean
syr-322-tzd-009 - nct00286494
Item
syr-322-tzd-009 - nct00286494
boolean
syr-322-ins-011 - nct00286429
Item
syr-322-ins-011 - nct00286429
boolean
01-05-tl-322opi-001 - nct00328627
Item
01-05-tl-322opi-001 - nct00328627
boolean
01-06-tl-322opi-002 - nct00395512
Item
01-06-tl-322opi-002 - nct00395512
boolean
alanine aminotransferase and serum creatinine measurement
Item
alanine aminotransferase less than or equal to 3 times the upper limit of normal and serum creatinine less than or equal to 2.0 mg per dl.
boolean
C0201836 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Home glucose monitor
Item
able and willing to monitor own blood glucose concentrations with a home glucose monitor.
boolean
C0917953 (UMLS CUI [1])
Comorbidity
Item
no major illness or debility that in the investigator's opinion prohibits the patient from completing the study.
boolean
C0009488 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adverse event
Item
the occurrence of any adverse event or condition during the controlled phase iii studies, which, in the opinion of the investigator, should exclude the patient from participating in the open-label extension.
boolean
C0877248 (UMLS CUI [1])
Pharmacotherapy
Item
is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
boolean
C0013216 (UMLS CUI [1])
Weight-loss drugs
Item
weight-loss drugs
boolean
C0376606 (UMLS CUI [1])
Investigational antidiabetics
Item
investigational antidiabetics, additional dipeptidyl peptidase-4 (dpp-4) and glucagon-like peptide-1 (glp 1) inhibitors
boolean
C0935929 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Incretin mimetics
Item
incretin mimetics,
boolean
C3839883 (UMLS CUI [1])
Glucocorticoids
Item
oral or systemically injected glucocorticoids.
boolean
C0017710 (UMLS CUI [1])

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