ID

20675

Beschrijving

Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00382096

Link

https://clinicaltrials.gov/show/NCT00382096

Trefwoorden

  1. 10-03-17 10-03-17 -
Geüploaded op

10 maart 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 2 NCT00382096

Eligibility Diabetes Mellitus, Type 2 NCT00382096

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Gender Nonfertile | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0232919
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
diagnosis of t2dm for at least 4 weeks prior to study entry
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0449238
age 18 - 78 years inclusive
Beschrijving

Age

Datatype

boolean

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

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
hba1c: 7.5 - 11% inclusive
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
pregnant or lactating female
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
a history of type 1 diabetes
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
evidence of significant diabetic complications
Beschrijving

Complications of Diabetes Mellitus Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0332120
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 NCT00382096

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Gender Nonfertile | Childbearing Potential Contraceptive methods
Item
male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0232919 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
diagnosis of t2dm for at least 4 weeks prior to study entry
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Age
Item
age 18 - 78 years inclusive
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of 22 - 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
hba1c: 7.5 - 11% inclusive
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)
Pregnancy | Breast Feeding
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
a history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Complications of Diabetes Mellitus Evidence of
Item
evidence of significant diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
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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