ID

35785

Beskrivning

Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02489968

Länk

https://clinicaltrials.gov/show/NCT02489968

Nyckelord

Versioner (1)
  1. 2019-03-22 2019-03-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02489968

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT02489968

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes prior to informed consent
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:
Beskrivning

Diet therapy | Exercise

Datatyp

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
Beskrivning

Antidiabetics Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332197
pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to the informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent). individual antidiabetic drug will have to be discontinued at visit 1.
Beskrivning

Antidiabetics Oral Quantity | Sulfonylurea | Antidiabetics Dose Stable | Thiazolidinediones unchanged | Antidiabetics Specific To be stopped

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0038766
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C1257987
UMLS CUI [4,2]
C0442739
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C0205369
UMLS CUI [5,3]
C1272691
haemoglobin a1c (hba1c) at visit 1 (screening)
Beskrivning

Glycosylated hemoglobin A

Datatyp

boolean

Alias
UMLS CUI [1]
C0019018
for patients without antidiabetic therapy : hba1c >=8.0 to =<10.5%
Beskrivning

Hemoglobin A1c measurement | Antidiabetics Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0332197
for patients with one oral antidiabetic drug : hba1c >=7.5 to =<10.5%
Beskrivning

Hemoglobin A1c measurement | Antidiabetics Oral Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
hba1c >=7.5 to =<10.0% at visit 4 for randomisation into the double blind treatment period
Beskrivning

Hemoglobin A1c measurement | Randomization Double-Blind Method

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0013072
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled hyperglycaemia with a glucose level >270 mg/dl (>15.0 mmol/l) during the open label stabilisation period and placebo run in period
Beskrivning

Hyperglycemia Uncontrolled | Glucose level

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0428548
impaired renal function, defined as estimated glomerular filtration rate (egfr) <45 ml/min/1.73m2 (modification of diet in renal disease (mdrd) formula)
Beskrivning

Renal Insufficiency | Renal function GFR estimation by MDRD

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2170215
acute coronary syndrome, stroke or transient ischemic attack (tia) within 12 weeks prior to informed consent
Beskrivning

Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
indication of liver disease, defined by serum levels of either alanine transaminase (alt), aspartate transaminase (ast), or alkaline phosphatase (alp) above 3 x upper limit of normal (uln)
Beskrivning

Indication Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151849
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02489968

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes prior to informed consent
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Exercise
Item
male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
Antidiabetics Absent
Item
drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
boolean
C0935929 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Antidiabetics Oral Quantity | Sulfonylurea | Antidiabetics Dose Stable | Thiazolidinediones unchanged | Antidiabetics Specific To be stopped
Item
pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to the informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent). individual antidiabetic drug will have to be discontinued at visit 1.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1257987 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C0205369 (UMLS CUI [5,2])
C1272691 (UMLS CUI [5,3])
Glycosylated hemoglobin A
Item
haemoglobin a1c (hba1c) at visit 1 (screening)
boolean
C0019018 (UMLS CUI [1])
Hemoglobin A1c measurement | Antidiabetics Absent
Item
for patients without antidiabetic therapy : hba1c >=8.0 to =<10.5%
boolean
C0474680 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hemoglobin A1c measurement | Antidiabetics Oral Quantity
Item
for patients with one oral antidiabetic drug : hba1c >=7.5 to =<10.5%
boolean
C0474680 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hemoglobin A1c measurement | Randomization Double-Blind Method
Item
hba1c >=7.5 to =<10.0% at visit 4 for randomisation into the double blind treatment period
boolean
C0474680 (UMLS CUI [1])
C0034656 (UMLS CUI [2,1])
C0013072 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hyperglycemia Uncontrolled | Glucose level
Item
uncontrolled hyperglycaemia with a glucose level >270 mg/dl (>15.0 mmol/l) during the open label stabilisation period and placebo run in period
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0428548 (UMLS CUI [2])
Renal Insufficiency | Renal function GFR estimation by MDRD
Item
impaired renal function, defined as estimated glomerular filtration rate (egfr) <45 ml/min/1.73m2 (modification of diet in renal disease (mdrd) formula)
boolean
C1565489 (UMLS CUI [1])
C2170215 (UMLS CUI [2])
Acute Coronary Syndrome | Cerebrovascular accident | Transient Ischemic Attack
Item
acute coronary syndrome, stroke or transient ischemic attack (tia) within 12 weeks prior to informed consent
boolean
C0948089 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Indication Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
indication of liver disease, defined by serum levels of either alanine transaminase (alt), aspartate transaminase (ast), or alkaline phosphatase (alp) above 3 x upper limit of normal (uln)
boolean
C3146298 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
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