ID

32939

Beschrijving

Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01026194

Link

https://clinicaltrials.gov/show/NCT01026194

Trefwoorden

  1. 21-11-18 21-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 november 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT01026194

Eligibility Type 2 Diabetes Mellitus NCT01026194

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are 20 - 75 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Beschrijving

Diet therapy | Exercise Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C0011849
patients whose hba1c is between 6.5% and 10.0%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
patients who took thiazolidinedione for diabetes over 16 weeks before administration of investigational drug
Beschrijving

Thiazolidinediones

Datatype

boolean

Alias
UMLS CUI [1]
C1257987
patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
Beschrijving

Antidiabetics Illicit Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332266
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc)
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus caused by Pancreatic Insufficiency | Secondary diabetes mellitus | Cushing's disease | Acromegaly

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0030293
UMLS CUI [3]
C0271640
UMLS CUI [4]
C0221406
UMLS CUI [5]
C0001206
patients who are accepting treatments of arrhythmias
Beschrijving

Treatment Cardiac Arrhythmia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0003811
patients with serious diabetic complications
Beschrijving

Complications of Diabetes Mellitus Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205404
patients who are the excessive alcohol addicts
Beschrijving

Alcohol addiction Excessive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001973
UMLS CUI [1,2]
C0442802
patients with severe hepatic disorder or severe renal disorder.
Beschrijving

Liver disease Severe | Kidney Disease Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205082
patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Beschrijving

Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unable

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750492
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C1299582

Similar models

Eligibility Type 2 Diabetes Mellitus NCT01026194

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients who are 20 - 75 years old
boolean
C0001779 (UMLS CUI [1])
Diet therapy | Exercise Diabetes Mellitus
Item
patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
patients whose hba1c is between 6.5% and 10.0%
boolean
C0474680 (UMLS CUI [1])
Thiazolidinediones
Item
patients who took thiazolidinedione for diabetes over 16 weeks before administration of investigational drug
boolean
C1257987 (UMLS CUI [1])
Antidiabetics Illicit Absent
Item
patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
boolean
C0935929 (UMLS CUI [1,1])
C0332266 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus caused by Pancreatic Insufficiency | Secondary diabetes mellitus | Cushing's disease | Acromegaly
Item
patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc)
boolean
C0011854 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0030293 (UMLS CUI [2,3])
C0271640 (UMLS CUI [3])
C0221406 (UMLS CUI [4])
C0001206 (UMLS CUI [5])
Treatment Cardiac Arrhythmia
Item
patients who are accepting treatments of arrhythmias
boolean
C0087111 (UMLS CUI [1,1])
C0003811 (UMLS CUI [1,2])
Complications of Diabetes Mellitus Serious
Item
patients with serious diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Alcohol addiction Excessive
Item
patients who are the excessive alcohol addicts
boolean
C0001973 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
Liver disease Severe | Kidney Disease Severe
Item
patients with severe hepatic disorder or severe renal disorder.
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unable
Item
patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])

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