ID

20690

Beschrijving

Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as Add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00396227

Link

https://clinicaltrials.gov/show/NCT00396227

Trefwoorden

  1. 11-03-17 11-03-17 -
Geüploaded op

11 maart 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 2 NCT00396227

Eligibility Diabetes Mellitus, Type 2 NCT00396227

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to visit 1 (week-2)
Beschrijving

Metformin Dose Stable U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
agreement to maintain the same dose of metformin from screening to the end of the study
Beschrijving

Metformin Dose Maintenance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0024501
age in the range of 18-80 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi) in the range of 22-40 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
hba1c in the range of 7.0 to 10%
Beschrijving

Glycosylated hemoglobin A Percentage

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
fpg <270 mg/dl (15 mmol/l)
Beschrijving

Plasma fasting glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of type 1 diabetes
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
liver disease
Beschrijving

Liver disease

Datatype

boolean

Alias
UMLS CUI [1]
C0023895
treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to visit 1
Beschrijving

Insulin | Antidiabetics Oral | Metformin

Datatype

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0025598
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Clinical Trial Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00396227

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Metformin Dose Stable U/day
Item
patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to visit 1 (week-2)
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
Metformin Dose Maintenance
Item
agreement to maintain the same dose of metformin from screening to the end of the study
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0024501 (UMLS CUI [1,3])
Age
Item
age in the range of 18-80 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) in the range of 22-40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
hba1c in the range of 7.0 to 10%
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fpg <270 mg/dl (15 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
a history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Liver disease
Item
liver disease
boolean
C0023895 (UMLS CUI [1])
Insulin | Antidiabetics Oral | Metformin
Item
treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to visit 1
boolean
C0021641 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])

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