ID

32934

Beschreibung

Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00974090

Link

https://clinicaltrials.gov/show/NCT00974090

Stichworte

Versionen (2)
  1. 20.11.18 20.11.18 -
  2. 21.11.18 21.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

21. November 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00974090

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00974090

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

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
Beschreibung

Diet therapy | Exercise Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C0011849
patients whose hba1c is between 7.0% and 10.0%
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
patients who took sulfonylurea for diabetes over 12 weeks before administration of investigational drug
Beschreibung

Sulfonylurea

Datentyp

boolean

Alias
UMLS CUI [1]
C0038766
patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
Beschreibung

Antidiabetics Illicit Absent

Datentyp

boolean

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

Exclusion Criteria

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

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

Datentyp

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 nyha functional classification
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
patients who are gastrointestinal disorder (diarrhea, vomiting)
Beschreibung

Gastrointestinal Disease | Diarrhea | Vomiting

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0011991
UMLS CUI [3]
C0042963
patients with serious diabetic complications
Beschreibung

Complications of Diabetes Mellitus Serious

Datentyp

boolean

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

Alcohol addiction Excessive

Datentyp

boolean

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

Liver disease Severe | Kidney Disease Severe

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding | Pregnancy Probably | Contraceptive methods Unable

Datentyp

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
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00974090

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 7.0% and 10.0%
boolean
C0474680 (UMLS CUI [1])
Sulfonylurea
Item
patients who took sulfonylurea for diabetes over 12 weeks before administration of investigational drug
boolean
C0038766 (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])
Heart failure New York Heart Association Classification
Item
patients with class iii/iv heart failure symptoms according to nyha functional classification
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Gastrointestinal Disease | Diarrhea | Vomiting
Item
patients who are gastrointestinal disorder (diarrhea, vomiting)
boolean
C0017178 (UMLS CUI [1])
C0011991 (UMLS CUI [2])
C0042963 (UMLS CUI [3])
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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