ID

23436

Descripción

A Comparison Between Glargine and Detemir Insulin in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00457093

Link

https://clinicaltrials.gov/show/NCT00457093

Palabras clave

Versiones (1)
  1. 4/7/17 4/7/17 -
Subido en

4 de julio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00457093

Inglés

Eligibility Type 2 Diabetes NCT00457093

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
currently on a basal insulin, that is, nph, glargine or detemir
Descripción

Basal insulin | NPH | Glargine | Detemir

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0650607
UMLS CUI [2]
C0021658
UMLS CUI [3]
C0907402
UMLS CUI [4]
C0537270
capable of self monitoring glucose >4/day
Descripción

Blood Glucose Self-Monitoring Ability

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0085732
previously complaint with clinical recommendations
Descripción

Complaint

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277786
subject may be on oral antiglycemic medications but no change in treatment is permitted during study.
Descripción

Oral hypoglycemic | Therapeutic procedure unchanged

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0442739
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
hb a1c >9.0%
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
urinary ketosis
Descripción

Ketosis urinary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022638
UMLS CUI [1,2]
C1524119
currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatine >1.5 mg/dl) glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistance of another)
Descripción

Insulin Sensitivity Alteration Expected | major surgery | Communicable Diseases | Kidney Failure | Creatinine measurement, serum | Glucocorticoids | Hypoglycaemic episode Serious | Assistance Patient need for

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920563
UMLS CUI [1,2]
C1515926
UMLS CUI [1,3]
C1517001
UMLS CUI [2]
C0679637
UMLS CUI [3]
C0009450
UMLS CUI [4]
C0035078
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0017710
UMLS CUI [7,1]
C0745153
UMLS CUI [7,2]
C0205404
UMLS CUI [8,1]
C1269765
UMLS CUI [8,2]
C0686904
currently participating in another clinical trial
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
known or suspected allergy to insulin glargine or detemir
Descripción

Insulin allergy | Hypersensitivity Glargine | Hypersensitivity Detemir | Insulin allergy Suspected | Hypersensitivity Glargine Suspected | Hypersensitivity Detemir Suspected

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571622
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0907402
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0537270
UMLS CUI [4,1]
C0571622
UMLS CUI [4,2]
C0750491
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0907402
UMLS CUI [5,3]
C0750491
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0537270
UMLS CUI [6,3]
C0750491
using other insulins, such as, bolus insulin or premixed insulin
Descripción

Insulin Bolus | premixed insulin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1705509
UMLS CUI [2]
C2069057
sight or hearing impaired
Descripción

Visual Impairment | hearing impairment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3665347
UMLS CUI [2]
C1384666
pregnancy oor nursing of the intention of becoming pregnant or not using adequate contraceptive measures.
Descripción

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Lacking

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332268
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Similar models

Eligibility Type 2 Diabetes NCT00457093

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Basal insulin | NPH | Glargine | Detemir
Item
currently on a basal insulin, that is, nph, glargine or detemir
boolean
C0650607 (UMLS CUI [1])
C0021658 (UMLS CUI [2])
C0907402 (UMLS CUI [3])
C0537270 (UMLS CUI [4])
Blood Glucose Self-Monitoring Ability
Item
capable of self monitoring glucose >4/day
boolean
C0005803 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Complaint
Item
previously complaint with clinical recommendations
boolean
C0277786 (UMLS CUI [1])
Oral hypoglycemic | Therapeutic procedure unchanged
Item
subject may be on oral antiglycemic medications but no change in treatment is permitted during study.
boolean
C0359086 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Glycosylated hemoglobin A
Item
hb a1c >9.0%
boolean
C0019018 (UMLS CUI [1])
Ketosis urinary
Item
urinary ketosis
boolean
C0022638 (UMLS CUI [1,1])
C1524119 (UMLS CUI [1,2])
Insulin Sensitivity Alteration Expected | major surgery | Communicable Diseases | Kidney Failure | Creatinine measurement, serum | Glucocorticoids | Hypoglycaemic episode Serious | Assistance Patient need for
Item
currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatine >1.5 mg/dl) glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistance of another)
boolean
C0920563 (UMLS CUI [1,1])
C1515926 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C0679637 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C0035078 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0017710 (UMLS CUI [6])
C0745153 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C1269765 (UMLS CUI [8,1])
C0686904 (UMLS CUI [8,2])
Study Subject Participation Status
Item
currently participating in another clinical trial
boolean
C2348568 (UMLS CUI [1])
Insulin allergy | Hypersensitivity Glargine | Hypersensitivity Detemir | Insulin allergy Suspected | Hypersensitivity Glargine Suspected | Hypersensitivity Detemir Suspected
Item
known or suspected allergy to insulin glargine or detemir
boolean
C0571622 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0537270 (UMLS CUI [3,2])
C0571622 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0907402 (UMLS CUI [5,2])
C0750491 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C0537270 (UMLS CUI [6,2])
C0750491 (UMLS CUI [6,3])
Insulin Bolus | premixed insulin
Item
using other insulins, such as, bolus insulin or premixed insulin
boolean
C0021641 (UMLS CUI [1,1])
C1705509 (UMLS CUI [1,2])
C2069057 (UMLS CUI [2])
Visual Impairment | hearing impairment
Item
sight or hearing impaired
boolean
C3665347 (UMLS CUI [1])
C1384666 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Lacking
Item
pregnancy oor nursing of the intention of becoming pregnant or not using adequate contraceptive measures.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
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