ID

37317

Beskrivning

Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02081599

Länk

https://clinicaltrials.gov/show/NCT02081599

Nyckelord

Versioner (1)
  1. 2019-07-16 2019-07-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02081599

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT02081599

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug
Beskrivning

Insulin Dose Stable | Insulin regime Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0205360
patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
Beskrivning

Diet therapy | Therapeutic exercise Duration Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2,1]
C1455811
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0011849
patients whose hba1c is between 7.5% and 10.5%
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

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

Absence Antidiabetics Illicit

Datatyp

boolean

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

Exclusion Criteria

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

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0030274
UMLS CUI [2,4]
C0221099
UMLS CUI [3]
C0271640
UMLS CUI [4]
C0221406
UMLS CUI [5]
C0001206
patients who are accepting treatments of arrhythmias
Beskrivning

Treatment Cardiac Arrhythmia

Datatyp

boolean

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

Complications of Diabetes Mellitus Serious

Datatyp

boolean

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

Alcohol addiction Excessive

Datatyp

boolean

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

Liver disease Severe | Kidney Disease Severe

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding | Pregnancy Probably | Patients Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750492
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0558080
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02081599

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin Dose Stable | Insulin regime Stable
Item
patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational drug
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0557978 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Diet therapy | Therapeutic exercise Duration 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])
C1455811 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0011849 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
patients whose hba1c is between 7.5% and 10.5%
boolean
C0474680 (UMLS CUI [1])
Absence Antidiabetics Illicit
Item
patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.
boolean
C0332197 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C0332266 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus caused by Pancreas Impairment | 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])
C0030274 (UMLS CUI [2,3])
C0221099 (UMLS CUI [2,4])
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 | Patients Contraceptive methods Unwilling
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])
C0030705 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
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