ID

33040

Beschrijving

Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00683657

Link

https://clinicaltrials.gov/show/NCT00683657

Trefwoorden

  1. 2018-11-24 2018-11-24 -
Houder van rechten

See clinicaltrial.gov

Geüploaded op

24 november 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Type 2 Diabetes NCT00683657

Eligibility Type 2 Diabetes NCT00683657

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
≥18- and ≤77-years-old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
taking metformin immediate release (ir) or xr ≥1500 mg for at least 8 weeks as monotherapy
Beschrijving

Metformin Immediate Release | Metformin Extended Release

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C1708470
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C1707968
glycosylated hemoglobin (a1c) ≥7% and ≤10%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) ≤40 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential unable or unwilling to use acceptable birth control
Beschrijving

Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
women who are pregnant or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant cardiovascular history
Beschrijving

Cardiovascular History

Datatype

boolean

Alias
UMLS CUI [1]
C1880008
active liver disease
Beschrijving

Liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
renal impairment
Beschrijving

Renal Insufficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1565489

Similar models

Eligibility Type 2 Diabetes NCT00683657

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
≥18- and ≤77-years-old
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Metformin Immediate Release | Metformin Extended Release
Item
taking metformin immediate release (ir) or xr ≥1500 mg for at least 8 weeks as monotherapy
boolean
C0025598 (UMLS CUI [1,1])
C1708470 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C1707968 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
glycosylated hemoglobin (a1c) ≥7% and ≤10%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) ≤40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling
Item
women of childbearing potential unable or unwilling to use acceptable birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular History
Item
significant cardiovascular history
boolean
C1880008 (UMLS CUI [1])
Liver disease
Item
active liver disease
boolean
C0023895 (UMLS CUI [1])
Renal Insufficiency
Item
renal impairment
boolean
C1565489 (UMLS CUI [1])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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