ID

29197

Beschreibung

Self Titration With Apidra to Reach Target Study (START); ODM derived from: https://clinicaltrials.gov/show/NCT01013571

Link

https://clinicaltrials.gov/show/NCT01013571

Stichworte

Versionen (1)
  1. 06.03.18 06.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

6. März 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01013571

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT01013571

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
run-in phase:
Beschreibung

Run-in Period

Datentyp

boolean

Alias
UMLS CUI [1]
C3274438
t2dm
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
treated for at least 3 months with a basal insulin (insulin glargine, nph, detemir)
Beschreibung

Basal insulin | Insulin Glargine | NPH insulin | Detemir

Datentyp

boolean

Alias
UMLS CUI [1]
C0650607
UMLS CUI [2]
C0907402
UMLS CUI [3]
C0021658
UMLS CUI [4]
C0537270
+/- oral antidiabetic drugs (oads) with an hba1c >7.0% or insulin naive (2-3 oads) with an hba1c >=7.8% (historic hba1c result up to 3 months of screening is acceptable)
Beschreibung

Antidiabetics Oral | Glucohemoglobin measurement | Insulin naive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0202054
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0919936
randomized treatment phase:
Beschreibung

Randomization Treatment Phase

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205390
completed run-in phase
Beschreibung

Run-in Period Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3274438
UMLS CUI [1,2]
C0205197
hba1c >7.0% and >= 1 episode of confirmed nocturnal hypoglycemia (bg <4.0 mmol/l) or >= 2 measurements of fg <=6.0 mmol/l within the previous week patients who completed the run-in phase with hba1c >7.0% and did not meet the randomization criteria will continue titrating insulin glargine and be followed until the end of study.
Beschreibung

Glucohemoglobin measurement | Nocturnal hypoglycemia Episode Quantity | Blood glucose measurement | Fasting Glucose measurement Quantity | Insulin Glargine

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2,1]
C0342315
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0392201
UMLS CUI [4,1]
C0202045
UMLS CUI [4,2]
C1265611
UMLS CUI [5]
C0907402
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
no food intake before lunch (noon)
Beschreibung

Oral food intake Absent Before Lunch

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0518037
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1550741
unstable diet intake or significant changes to current diet regimen
Beschreibung

Diet Intake Unstable | Diet therapy Change

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C0012159
UMLS CUI [2,2]
C0392747
nightshift worker
Beschreibung

Night shift worker

Datentyp

boolean

Alias
UMLS CUI [1]
C0555008
type 1 diabetes mellitus
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
subjects unwilling to inject insulin or perform self-monitoring blood glucose
Beschreibung

Insulin injection Unwilling | Blood Glucose Self-Monitoring Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0199782
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0005803
UMLS CUI [2,2]
C0558080
pregnant, alcohol or drug abuse
Beschreibung

Pregnancy | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0038586
active cancer or any other disease or condition which in the opinion of the investigator would make the subject unsuitable for participation in the study
Beschreibung

Malignant Neoplasms Study Subject Participation Status Inappropriate | Disease Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1548788
any clinical significant laboratory findings that in the judgment of the investigator would preclude safe completion of the study
Beschreibung

Laboratory test findings Clinical Significance Exclude Completion of clinical trial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C2732579
known allergies to study drugs
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschreibung

Study Subject Participation Status Aspect Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1879746
UMLS CUI [1,3]
C1524062
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT01013571

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Run-in Period
Item
run-in phase:
boolean
C3274438 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
t2dm
boolean
C0011860 (UMLS CUI [1])
Basal insulin | Insulin Glargine | NPH insulin | Detemir
Item
treated for at least 3 months with a basal insulin (insulin glargine, nph, detemir)
boolean
C0650607 (UMLS CUI [1])
C0907402 (UMLS CUI [2])
C0021658 (UMLS CUI [3])
C0537270 (UMLS CUI [4])
Antidiabetics Oral | Glucohemoglobin measurement | Insulin naive
Item
+/- oral antidiabetic drugs (oads) with an hba1c >7.0% or insulin naive (2-3 oads) with an hba1c >=7.8% (historic hba1c result up to 3 months of screening is acceptable)
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
C0021641 (UMLS CUI [3,1])
C0919936 (UMLS CUI [3,2])
Randomization Treatment Phase
Item
randomized treatment phase:
boolean
C0034656 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205390 (UMLS CUI [1,3])
Run-in Period Completed
Item
completed run-in phase
boolean
C3274438 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Glucohemoglobin measurement | Nocturnal hypoglycemia Episode Quantity | Blood glucose measurement | Fasting Glucose measurement Quantity | Insulin Glargine
Item
hba1c >7.0% and >= 1 episode of confirmed nocturnal hypoglycemia (bg <4.0 mmol/l) or >= 2 measurements of fg <=6.0 mmol/l within the previous week patients who completed the run-in phase with hba1c >7.0% and did not meet the randomization criteria will continue titrating insulin glargine and be followed until the end of study.
boolean
C0202054 (UMLS CUI [1])
C0342315 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0392201 (UMLS CUI [3])
C0202045 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0907402 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Oral food intake Absent Before Lunch
Item
no food intake before lunch (noon)
boolean
C0518037 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1550741 (UMLS CUI [1,3])
Diet Intake Unstable | Diet therapy Change
Item
unstable diet intake or significant changes to current diet regimen
boolean
C0012155 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0012159 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
Night shift worker
Item
nightshift worker
boolean
C0555008 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Insulin injection Unwilling | Blood Glucose Self-Monitoring Unwilling
Item
subjects unwilling to inject insulin or perform self-monitoring blood glucose
boolean
C0199782 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Pregnancy | Substance Use Disorders
Item
pregnant, alcohol or drug abuse
boolean
C0032961 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Malignant Neoplasms Study Subject Participation Status Inappropriate | Disease Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate
Item
active cancer or any other disease or condition which in the opinion of the investigator would make the subject unsuitable for participation in the study
boolean
C0006826 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1548788 (UMLS CUI [3,3])
Laboratory test findings Clinical Significance Exclude Completion of clinical trial
Item
any clinical significant laboratory findings that in the judgment of the investigator would preclude safe completion of the study
boolean
C0587081 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
Hypersensitivity Investigational New Drugs
Item
known allergies to study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Study Subject Participation Status Aspect Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C1879746 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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