ID

23249

Descripción

Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00361738

Link

https://clinicaltrials.gov/show/NCT00361738

Palabras clave

Versiones (1)
  1. 30/6/17 30/6/17 -
Subido en

30 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00361738

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00361738

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus, as defined by the american diabetes association, for at least one year at the time of screening.
Descripción

Non-Insulin-Dependent Diabetes Mellitus disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c measured at visit 1 in the range of ≥ 7.0 and < 9.0 %.
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in the study). no other antidiabetic medications are permitted for 3 months prior to enrollment.
Descripción

Metformin Stable Dose U/day | Antidiabetics Other Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0456683
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2828389
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding women.
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential not protected by medically approved contraceptive method of birth control.
Descripción

Childbearing Potential Contraceptive methods Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
bmi >40kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
diabetes other than type 2 diabetes.
Descripción

Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C2828389
subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis.
Descripción

Brittle diabetes | Hospitalization Due to Diabetic - poor control | Emergency department patient visit Due to Diabetic - poor control | Dehydration Diabetes Related Hospitalization Required | Ketoacidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342302
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0421258
UMLS CUI [3,1]
C0586082
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0421258
UMLS CUI [4,1]
C0011175
UMLS CUI [4,2]
C0011847
UMLS CUI [4,3]
C0439849
UMLS CUI [4,4]
C1708385
UMLS CUI [5]
C0220982
presence or history of cancer within the past five years.
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization.
Descripción

Myocardial Infarction | Cerebrovascular accident | Retinal Diseases Requirement Laser Surgery | Heart failure Hospitalization Required

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0035309
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0023087
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1708385
impaired hepatic tests, impaired renal function.
Descripción

Liver Function Tests Impaired | Renal Insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023901
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C1565489
history or evidence of clinically relevant renal or urological disorder.
Descripción

Kidney Diseases | Urologic Diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0042075
the investigator will evaluate whether there are other reasons why a patient may not participate.
Descripción

Exclusion Criteria Additional

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00361738

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 2 diabetes mellitus, as defined by the american diabetes association, for at least one year at the time of screening.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glycosylated hemoglobin A
Item
hba1c measured at visit 1 in the range of ≥ 7.0 and < 9.0 %.
boolean
C0019018 (UMLS CUI [1])
Metformin Stable Dose U/day | Antidiabetics Other Excluded
Item
stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in the study). no other antidiabetic medications are permitted for 3 months prior to enrollment.
boolean
C0025598 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0935929 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Lacking
Item
women of childbearing potential not protected by medically approved contraceptive method of birth control.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Body mass index
Item
bmi >40kg/m2
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus Excluded
Item
diabetes other than type 2 diabetes.
boolean
C0011849 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Brittle diabetes | Hospitalization Due to Diabetic - poor control | Emergency department patient visit Due to Diabetic - poor control | Dehydration Diabetes Related Hospitalization Required | Ketoacidosis
Item
subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis.
boolean
C0342302 (UMLS CUI [1])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0421258 (UMLS CUI [2,3])
C0586082 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0421258 (UMLS CUI [3,3])
C0011175 (UMLS CUI [4,1])
C0011847 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
C1708385 (UMLS CUI [4,4])
C0220982 (UMLS CUI [5])
Malignant Neoplasms
Item
presence or history of cancer within the past five years.
boolean
C0006826 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Retinal Diseases Requirement Laser Surgery | Heart failure Hospitalization Required
Item
evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0035309 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0023087 (UMLS CUI [3,3])
C0018801 (UMLS CUI [4,1])
C1708385 (UMLS CUI [4,2])
Liver Function Tests Impaired | Renal Insufficiency
Item
impaired hepatic tests, impaired renal function.
boolean
C0023901 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2])
Kidney Diseases | Urologic Diseases
Item
history or evidence of clinically relevant renal or urological disorder.
boolean
C0022658 (UMLS CUI [1])
C0042075 (UMLS CUI [2])
Exclusion Criteria Additional
Item
the investigator will evaluate whether there are other reasons why a patient may not participate.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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