ID

20839

Description

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

Keywords

  1. 3/21/17 3/21/17 -
Uploaded on

March 21, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus NCT00306384

Eligibility Diabetes Mellitus NCT00306384

Inclusion Criteria
Description

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.
Description

Gynaecological status

Data type

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:
Description

Diabetes mellitus type 2 and study participation status

Data type

boolean

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

syr-322-plc-010 - nct00286455

Data type

boolean

syr-322-sulf-007 - nct00286468
Description

syr-322-sulf-007 - nct00286468

Data type

boolean

syr-322-met-008 - nct00286442
Description

syr-322-met-008 - nct00286442

Data type

boolean

syr-322-tzd-009 - nct00286494
Description

syr-322-tzd-009 - nct00286494

Data type

boolean

syr-322-ins-011 - nct00286429
Description

syr-322-ins-011 - nct00286429

Data type

boolean

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

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

Data type

boolean

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

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

Data type

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.
Description

alanine aminotransferase and serum creatinine measurement

Data type

boolean

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

Home glucose monitor

Data type

boolean

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

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Exclusion Criteria
Description

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.
Description

Adverse event

Data type

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:
Description

Pharmacotherapy

Data type

boolean

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

Weight-loss drugs

Data type

boolean

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

Investigational antidiabetics

Data type

boolean

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

Incretin mimetics

Data type

boolean

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

Glucocorticoids

Data type

boolean

Alias
UMLS CUI [1]
C0017710

Similar models

Eligibility Diabetes Mellitus NCT00306384

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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