ID

38839

Beschreibung

Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01194258

Link

https://clinicaltrials.gov/show/NCT01194258

Stichworte

Versionen (1)
  1. 08.11.19 08.11.19 -
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See clinicaltrials.gov

Hochgeladen am

8. November 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type II NCT01194258

Englisch

Eligibility Diabetes Mellitus, Type II NCT01194258

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females ≥18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes mellitus (t2dm) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Insulin regime | Insulin During meal

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0557978
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0587120
body mass index (bmi) of 23.0 to 45.0 kilograms per meter squared (kg/m^2)
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
glycosylated hemoglobin (hba1c) level 7.0 to 8.5%, inclusive
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
fasting c-peptide <0.6 nanograms per milliliter (ng/ml)
Beschreibung

Fasting C-peptide level

Datentyp

boolean

Alias
UMLS CUI [1]
C2208720
willingness to use insulin glargine twice a day as basal insulin for the duration of the study
Beschreibung

Insulin Glargine times per day | Basal insulin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0907402
UMLS CUI [1,2]
C0439511
UMLS CUI [2]
C0650607
willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (cgm) during the study
Beschreibung

Avoidance Insulin pump | Avoidance Continuous glucose monitoring

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C1140609
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C4523945
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to any component of any of the study drugs
Beschreibung

Hypersensitivity Investigational New Drug Component | Hypersensitivity Suspected Investigational New Drug Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [2,4]
C1705248
exclusive use of pre-mixed insulins
Beschreibung

Use of Premixed insulin Exclusive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C2069057
UMLS CUI [1,3]
C1548966
use of pramlintide, exenatide, and/or liraglutide within 30 days of screening
Beschreibung

Pramlintide | exenatide | liraglutide

Datentyp

boolean

Alias
UMLS CUI [1]
C0537551
UMLS CUI [2]
C0167117
UMLS CUI [3]
C1456408
use of sulfonylureas within two months of screening
Beschreibung

Sulfonylureas

Datentyp

boolean

Alias
UMLS CUI [1]
C0038766
use of drugs (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, during the study or within 30 days of screening
Beschreibung

Pharmaceutical Preparation Interferes with Interpretation Research results | Adrenal Cortex Hormones | Antimetabolites | Pharmaceutical Preparation Interferes with Insulin use | Pharmaceutical Preparation Interferes with Glucose utilization | Pharmaceutical Preparation Interferes with Recovery Hypoglycemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0459471
UMLS CUI [1,4]
C0683954
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0003376
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0240016
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0017725
UMLS CUI [5,4]
C0042153
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2004454
UMLS CUI [6,4]
C0020615
recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator
Beschreibung

Recurrent severe hypoglycemia | Loss of hypoglycemic warning

Datentyp

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type II NCT01194258

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males or females ≥18 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Insulin regime | Insulin During meal
Item
type 2 diabetes mellitus (t2dm) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months
boolean
C0011860 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
C0021641 (UMLS CUI [3,1])
C0587120 (UMLS CUI [3,2])
Body mass index
Item
body mass index (bmi) of 23.0 to 45.0 kilograms per meter squared (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated hemoglobin (hba1c) level 7.0 to 8.5%, inclusive
boolean
C0474680 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting c-peptide <0.6 nanograms per milliliter (ng/ml)
boolean
C2208720 (UMLS CUI [1])
Insulin Glargine times per day | Basal insulin
Item
willingness to use insulin glargine twice a day as basal insulin for the duration of the study
boolean
C0907402 (UMLS CUI [1,1])
C0439511 (UMLS CUI [1,2])
C0650607 (UMLS CUI [2])
Avoidance Insulin pump | Avoidance Continuous glucose monitoring
Item
willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (cgm) during the study
boolean
C0870186 (UMLS CUI [1,1])
C1140609 (UMLS CUI [1,2])
C0870186 (UMLS CUI [2,1])
C4523945 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drug Component | Hypersensitivity Suspected Investigational New Drug Component
Item
known or suspected allergy to any component of any of the study drugs
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C1705248 (UMLS CUI [2,4])
Use of Premixed insulin Exclusive
Item
exclusive use of pre-mixed insulins
boolean
C1524063 (UMLS CUI [1,1])
C2069057 (UMLS CUI [1,2])
C1548966 (UMLS CUI [1,3])
Pramlintide | exenatide | liraglutide
Item
use of pramlintide, exenatide, and/or liraglutide within 30 days of screening
boolean
C0537551 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C1456408 (UMLS CUI [3])
Sulfonylureas
Item
use of sulfonylureas within two months of screening
boolean
C0038766 (UMLS CUI [1])
Pharmaceutical Preparation Interferes with Interpretation Research results | Adrenal Cortex Hormones | Antimetabolites | Pharmaceutical Preparation Interferes with Insulin use | Pharmaceutical Preparation Interferes with Glucose utilization | Pharmaceutical Preparation Interferes with Recovery Hypoglycemia
Item
use of drugs (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, during the study or within 30 days of screening
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,3])
C0683954 (UMLS CUI [1,4])
C0001617 (UMLS CUI [2])
C0003376 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0240016 (UMLS CUI [4,3])
C0013227 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0017725 (UMLS CUI [5,3])
C0042153 (UMLS CUI [5,4])
C0013227 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2004454 (UMLS CUI [6,3])
C0020615 (UMLS CUI [6,4])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
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