ID

35741

Beskrivning

Empagliflozin as Adjunctive to inSulin thErapy in Type 1 Diabetes Over 52 Weeks (EASE-2); ODM derived from: https://clinicaltrials.gov/show/NCT02414958

Länk

https://clinicaltrials.gov/show/NCT02414958

Nyckelord

Versioner (1)
  1. 2019-03-19 2019-03-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT02414958

Engelsk

Eligibility Diabetes Mellitus, Type 1 NCT02414958

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patient receiving insulin for the treatment of documented diagnosis of t1dm for at least 1 year at the time of visit 1
Beskrivning

Insulin regime Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011854
UMLS CUI [1,3]
C0872146
fasting c-peptide value of < 0.7 ng/ml (0.23 nmol/l) at visit 2 measured by the central laboratory
Beskrivning

Fasting C-peptide level

Datatyp

boolean

Alias
UMLS CUI [1]
C2208720
use of, and be willing, based on the investigator's judgement, to continue throughout the duration of the trial, either:
Beskrivning

Use of

Datatyp

boolean

Alias
UMLS CUI [1]
C1524063
mdi of insulin consisting of at least one basal insulin injection and at least three daily bolus injections or
Beskrivning

Daily Dose Multiple Injection of insulin | Basal insulin Injection Quantity | Bolus infusion Quantity Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0199782
UMLS CUI [2,1]
C0650607
UMLS CUI [2,2]
C1828121
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1511237
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0332173
csii of any insulin type, with at least 5 months experience of using csii prior to visit 1
Beskrivning

Continuous subcutaneous infusion of insulin Type Any

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0393124
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
hba1c >/= 7.5% and </= 10.0% at visit 5 measured by the central laboratory
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
age >/= 18 years at visit 1
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
additional inclusion criteria may apply
Beskrivning

Inclusion criteria Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of t2dm, maturity onset diabetes of the young (mody), pancreatic surgery or chronic pancreatitis
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent | Maturity onset diabetes mellitus in young | Pancreatic surgery | Pancreatitis, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0342276
UMLS CUI [3]
C2033062
UMLS CUI [4]
C0149521
pancreas, pancreatic islet cells or renal transplant recipient
Beskrivning

Pancreas transplant recipient | Islets of Langerhans Transplant Recipients | Renal transplant recipient

Datatyp

boolean

Alias
UMLS CUI [1]
C2033004
UMLS CUI [2,1]
C0022131
UMLS CUI [2,2]
C0376387
UMLS CUI [3]
C2063399
t1dm treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, glp-1 analogues, sglt-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to visit 1
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Hypoglycemic Agents | Metformin | alpha-Glucosidase Inhibitors | GLP-1 Analogue | SGLT2 Inhibitor | Pramlintide | Insulin By inhalation | Premixed insulin | Exception Basal insulin Subcutaneous | Exception Insulin Bolus

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0020616
UMLS CUI [3]
C0025598
UMLS CUI [4]
C1299007
UMLS CUI [5]
C3273809
UMLS CUI [6]
C3273807
UMLS CUI [7]
C0537551
UMLS CUI [8,1]
C0021641
UMLS CUI [8,2]
C0001559
UMLS CUI [9]
C2069057
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0650607
UMLS CUI [10,3]
C1522438
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0021641
UMLS CUI [11,3]
C1705509
occurrence of severe hypoglycaemia involving coma and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to visit 1
Beskrivning

Hypoglycemia Severe Involving Coma | Hypoglycemia Severe Involving Seizure | Hospitalization Required | Patient need for Emergency treatment Hypoglycemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0009421
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0036572
UMLS CUI [3]
C1708385
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0013969
UMLS CUI [4,3]
C0020615
occurence of severe dka (i.e a ph of <7.0 or prolonged intensive care unit admission exceeding two days) requiring hospitalisation within 3 months prior to visit 1
Beskrivning

Diabetic Ketoacidosis Severe | Finding of pH | Admission to intensive care unit Prolonged | Hospitalization Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011880
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1304686
UMLS CUI [3,1]
C0583239
UMLS CUI [3,2]
C0439590
UMLS CUI [4]
C1708385
additional exclusion criteria may apply
Beskrivning

Exclusion Criteria Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT02414958

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin regime Insulin-Dependent Diabetes Mellitus Disease length
Item
male or female patient receiving insulin for the treatment of documented diagnosis of t1dm for at least 1 year at the time of visit 1
boolean
C0557978 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
C0872146 (UMLS CUI [1,3])
Fasting C-peptide level
Item
fasting c-peptide value of < 0.7 ng/ml (0.23 nmol/l) at visit 2 measured by the central laboratory
boolean
C2208720 (UMLS CUI [1])
Use of
Item
use of, and be willing, based on the investigator's judgement, to continue throughout the duration of the trial, either:
boolean
C1524063 (UMLS CUI [1])
Daily Dose Multiple Injection of insulin | Basal insulin Injection Quantity | Bolus infusion Quantity Daily
Item
mdi of insulin consisting of at least one basal insulin injection and at least three daily bolus injections or
boolean
C2348070 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0199782 (UMLS CUI [1,3])
C0650607 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1511237 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
Continuous subcutaneous infusion of insulin Type Any
Item
csii of any insulin type, with at least 5 months experience of using csii prior to visit 1
boolean
C0393124 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
hba1c >/= 7.5% and </= 10.0% at visit 5 measured by the central laboratory
boolean
C0474680 (UMLS CUI [1])
Age
Item
age >/= 18 years at visit 1
boolean
C0001779 (UMLS CUI [1])
Inclusion criteria Additional
Item
additional inclusion criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Maturity onset diabetes mellitus in young | Pancreatic surgery | Pancreatitis, Chronic
Item
history of t2dm, maturity onset diabetes of the young (mody), pancreatic surgery or chronic pancreatitis
boolean
C0011860 (UMLS CUI [1])
C0342276 (UMLS CUI [2])
C2033062 (UMLS CUI [3])
C0149521 (UMLS CUI [4])
Pancreas transplant recipient | Islets of Langerhans Transplant Recipients | Renal transplant recipient
Item
pancreas, pancreatic islet cells or renal transplant recipient
boolean
C2033004 (UMLS CUI [1])
C0022131 (UMLS CUI [2,1])
C0376387 (UMLS CUI [2,2])
C2063399 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Hypoglycemic Agents | Metformin | alpha-Glucosidase Inhibitors | GLP-1 Analogue | SGLT2 Inhibitor | Pramlintide | Insulin By inhalation | Premixed insulin | Exception Basal insulin Subcutaneous | Exception Insulin Bolus
Item
t1dm treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, glp-1 analogues, sglt-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to visit 1
boolean
C0011854 (UMLS CUI [1])
C0020616 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C1299007 (UMLS CUI [4])
C3273809 (UMLS CUI [5])
C3273807 (UMLS CUI [6])
C0537551 (UMLS CUI [7])
C0021641 (UMLS CUI [8,1])
C0001559 (UMLS CUI [8,2])
C2069057 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0650607 (UMLS CUI [10,2])
C1522438 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C0021641 (UMLS CUI [11,2])
C1705509 (UMLS CUI [11,3])
Hypoglycemia Severe Involving Coma | Hypoglycemia Severe Involving Seizure | Hospitalization Required | Patient need for Emergency treatment Hypoglycemia
Item
occurrence of severe hypoglycaemia involving coma and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to visit 1
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0009421 (UMLS CUI [1,4])
C0020615 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0036572 (UMLS CUI [2,4])
C1708385 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C0013969 (UMLS CUI [4,2])
C0020615 (UMLS CUI [4,3])
Diabetic Ketoacidosis Severe | Finding of pH | Admission to intensive care unit Prolonged | Hospitalization Required
Item
occurence of severe dka (i.e a ph of <7.0 or prolonged intensive care unit admission exceeding two days) requiring hospitalisation within 3 months prior to visit 1
boolean
C0011880 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1304686 (UMLS CUI [2])
C0583239 (UMLS CUI [3,1])
C0439590 (UMLS CUI [3,2])
C1708385 (UMLS CUI [4])
Exclusion Criteria Additional
Item
additional exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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