ID

34599

Beschrijving

Evaluation of Dapagliflozin Taken Twice-daily; ODM derived from: https://clinicaltrials.gov/show/NCT01217892

Link

https://clinicaltrials.gov/show/NCT01217892

Trefwoorden

  1. 19-01-19 19-01-19 -
Houder van rechten

see on clinicaltrials.gov

Geüploaded op

19 januari 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT01217892

Eligibility Type 2 Diabetes NCT01217892

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of informed consent prior to any study specific procedures
Beschrijving

ID.1

Datatype

boolean

diagnosis of t2dm
Beschrijving

ID.2

Datatype

boolean

current antihyperglycaemic treatment with metformin immediate release formulation monotherapy >/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. other treatment with oads within the 10 weeks prior to enrolment is not permitted.
Beschrijving

ID.3

Datatype

boolean

hba1c ≥ 6.7% and ≤10.5%, based on central laboratory values from screening visit, and enrolment visit 1.
Beschrijving

ID.4

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of type 1 diabetes mellitus, known diagnosis of maturity onset diabetes of the young (mody) or secondary causes of diabetes mellitus
Beschrijving

ID.5

Datatype

boolean

history of diabetic ketoacidosis
Beschrijving

ID.6

Datatype

boolean

symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
Beschrijving

ID.7

Datatype

boolean

fpg >270 mg/dl (>15.0 mmol/l)
Beschrijving

ID.8

Datatype

boolean

bmi >45 kg/m2
Beschrijving

ID.9

Datatype

boolean

Similar models

Eligibility Type 2 Diabetes NCT01217892

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
provision of informed consent prior to any study specific procedures
boolean
ID.2
Item
diagnosis of t2dm
boolean
ID.3
Item
current antihyperglycaemic treatment with metformin immediate release formulation monotherapy >/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. other treatment with oads within the 10 weeks prior to enrolment is not permitted.
boolean
ID.4
Item
hba1c ≥ 6.7% and ≤10.5%, based on central laboratory values from screening visit, and enrolment visit 1.
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
diagnosis of type 1 diabetes mellitus, known diagnosis of maturity onset diabetes of the young (mody) or secondary causes of diabetes mellitus
boolean
ID.6
Item
history of diabetic ketoacidosis
boolean
ID.7
Item
symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
boolean
ID.8
Item
fpg >270 mg/dl (>15.0 mmol/l)
boolean
ID.9
Item
bmi >45 kg/m2
boolean

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