ID

33038

Beschrijving

Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00628212

Link

https://clinicaltrials.gov/show/NCT00628212

Trefwoorden

  1. 24-11-18 24-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

24 november 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT00628212

Eligibility Type 2 Diabetes NCT00628212

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 Diabetes Mellitus | Exercise Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012159
UMLS CUI [1,2]
C0011849
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C0011849
patients whose hba1c is 6.5 - 9.5%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
Beschrijving

Illicit Drugs Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086190
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, 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 with class iii/iv heart failure symptoms according to new york heart association (nyha) functional classification
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
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 habitual excessive alcohol consumption.
Beschrijving

Alcohol intake above recommended sensible limits

Datatype

boolean

Alias
UMLS CUI [1]
C0560219
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
pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Beschrijving

Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unwilling

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]
C0558080

Similar models

Eligibility Type 2 Diabetes NCT00628212

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 Diabetes Mellitus | 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 [1,1])
C0011849 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
patients whose hba1c is 6.5 - 9.5%
boolean
C0474680 (UMLS CUI [1])
Illicit Drugs Absent
Item
patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
boolean
C0086190 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
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 failure, 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])
Heart failure New York Heart Association Classification
Item
patients with class iii/iv heart failure symptoms according to new york heart association (nyha) functional classification
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (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 intake above recommended sensible limits
Item
patients who are habitual excessive alcohol consumption.
boolean
C0560219 (UMLS CUI [1])
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 Unwilling
Item
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])
C0558080 (UMLS CUI [4,2])

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