ID

32939

Description

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

Lien

https://clinicaltrials.gov/show/NCT01026194

Mots-clés

  1. 21/11/2018 21/11/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

21 novembre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes Mellitus NCT01026194

Eligibility Type 2 Diabetes Mellitus NCT01026194

Inclusion Criteria
Description

Inclusion Criteria

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

Age

Type de données

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
Description

Diet therapy | Exercise Diabetes Mellitus

Type de données

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%
Description

Hemoglobin A1c measurement

Type de données

boolean

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

Thiazolidinediones

Type de données

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.
Description

Antidiabetics Illicit Absent

Type de données

boolean

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

Exclusion Criteria

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

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

Type de données

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
Description

Treatment Cardiac Arrhythmia

Type de données

boolean

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

Complications of Diabetes Mellitus Serious

Type de données

boolean

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

Alcohol addiction Excessive

Type de données

boolean

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

Liver disease Severe | Kidney Disease Severe

Type de données

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
Description

Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unable

Type de données

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)
Type de données
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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