ID

19440

Beskrivning

24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine; ODM derived from: https://clinicaltrials.gov/show/NCT00551538

Länk

https://clinicaltrials.gov/show/NCT00551538

Nyckelord

Versioner (1)
  1. 2017-01-02 2017-01-02 -
Uppladdad den

2 januari 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Type 2 Diabetes NCT00551538

Engelsk

Eligibility Type 2 Diabetes NCT00551538

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
have inadequate overall glycemic control (hemoglobin a1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to visit 1
Beskrivning

Poor glycemic control | Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0342299
UMLS CUI [2]
C0202054
have used:
Beskrivning

Use of

Datatyp

boolean

Alias
UMLS CUI [1]
C1524063
single or multiple oams for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or
Beskrivning

Oral hypoglycemic Single | Oral hypoglycemics multiple | Metformin | Sulfonylurea | Meglitinide | repaglinide | nateglinide | alpha-Glucosidase Inhibitors | Acarbose | miglitol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C0205171
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0439064
UMLS CUI [3]
C0025598
UMLS CUI [4]
C0038766
UMLS CUI [5]
C0065880
UMLS CUI [6]
C0246689
UMLS CUI [7]
C0903898
UMLS CUI [8]
C1299007
UMLS CUI [9]
C0050393
UMLS CUI [10]
C0066535
insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or
Beskrivning

Insulin Once daily | Insulin Twice a day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0556983
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0585361
a combination of the above.
Beskrivning

Combination Pharmaceutical Preparations enumerated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205195
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1707927
are greater than or equal to 21 and less than 80 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
as determined by the investigator, are capable and willing to:
Beskrivning

Capability | Willing

Datatyp

boolean

Alias
UMLS CUI [1]
C2698977
UMLS CUI [2]
C0600109
comply with their prescribed diet and medication regimen,
Beskrivning

Compliance with prescribed diet | Compliance behavior to prescribed medication

Datatyp

boolean

Alias
UMLS CUI [1]
C4039442
UMLS CUI [2]
C2585769
perform self blood glucose monitoring,
Beskrivning

Blood Glucose Self-Monitoring

Datatyp

boolean

Alias
UMLS CUI [1]
C0005803
use the patient diary as required for this protocol,
Beskrivning

Study Protocol Subject Diary Use of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C3890583
UMLS CUI [1,3]
C1524063
participate in two 24 hour inpatient assessments
Beskrivning

Inpatient Assessment 24 Hours | Participation Assessment Two

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021562
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C1442770
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0205448
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
Beskrivning

Thiazolidinediones | pioglitazone | rosiglitazone

Datatyp

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0071097
UMLS CUI [3]
C0289313
are currently treated with a meglitinide without sulfonylurea
Beskrivning

Meglitinide | Sulfonylurea

Datatyp

boolean

Alias
UMLS CUI [1]
C0065880
UMLS CUI [2]
C0038766
have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
Beskrivning

Hypersensitivity Insulin Lispro Mix 25 75 | Intolerance to Insulin Lispro Mix 25 75 | Hypersensitivity Insulin Glargine | Intolerance to Insulin Glargine | Hypersensitivity Metformin | Intolerance to Metformin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0977811
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0977811
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0907402
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0907402
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0025598
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0025598
have plasma creatinine greater than or equal to 1.5 mg/dl (for males) or greater than or equal to 1.4 mg/dl (for females) for patients who will be treated with metformin or; greater than 2 mg/dl for patients treated with other oams, as determined by a local laboratory
Beskrivning

plasma creatinine measurement | Gender | Metformin | Oral hypoglycemics

Datatyp

boolean

Alias
UMLS CUI [1]
C1278055
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0025598
UMLS CUI [4]
C0359086
have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to visit 1
Beskrivning

Systemic Glucocorticoids chronic | Preparations topical | Inhaled drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540777
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1522168
UMLS CUI [3]
C0556393
Tillbaka till toppen

Similar models

Eligibility Type 2 Diabetes NCT00551538

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Poor glycemic control | Glucohemoglobin measurement
Item
have inadequate overall glycemic control (hemoglobin a1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to visit 1
boolean
C0342299 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
Use of
Item
have used:
boolean
C1524063 (UMLS CUI [1])
Oral hypoglycemic Single | Oral hypoglycemics multiple | Metformin | Sulfonylurea | Meglitinide | repaglinide | nateglinide | alpha-Glucosidase Inhibitors | Acarbose | miglitol
Item
single or multiple oams for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or
boolean
C0359086 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C0065880 (UMLS CUI [5])
C0246689 (UMLS CUI [6])
C0903898 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C0050393 (UMLS CUI [9])
C0066535 (UMLS CUI [10])
Insulin Once daily | Insulin Twice a day
Item
insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or
boolean
C0021641 (UMLS CUI [1,1])
C0556983 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C0585361 (UMLS CUI [2,2])
Combination Pharmaceutical Preparations enumerated
Item
a combination of the above.
boolean
C0205195 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1707927 (UMLS CUI [1,3])
Age
Item
are greater than or equal to 21 and less than 80 years of age
boolean
C0001779 (UMLS CUI [1])
Capability | Willing
Item
as determined by the investigator, are capable and willing to:
boolean
C2698977 (UMLS CUI [1])
C0600109 (UMLS CUI [2])
Compliance with prescribed diet | Compliance behavior to prescribed medication
Item
comply with their prescribed diet and medication regimen,
boolean
C4039442 (UMLS CUI [1])
C2585769 (UMLS CUI [2])
Blood Glucose Self-Monitoring
Item
perform self blood glucose monitoring,
boolean
C0005803 (UMLS CUI [1])
Study Protocol Subject Diary Use of
Item
use the patient diary as required for this protocol,
boolean
C2348563 (UMLS CUI [1,1])
C3890583 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
Inpatient Assessment 24 Hours | Participation Assessment Two
Item
participate in two 24 hour inpatient assessments
boolean
C0021562 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0205448 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones | pioglitazone | rosiglitazone
Item
have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study
boolean
C1257987 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
C0289313 (UMLS CUI [3])
Meglitinide | Sulfonylurea
Item
are currently treated with a meglitinide without sulfonylurea
boolean
C0065880 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
Hypersensitivity Insulin Lispro Mix 25 75 | Intolerance to Insulin Lispro Mix 25 75 | Hypersensitivity Insulin Glargine | Intolerance to Insulin Glargine | Hypersensitivity Metformin | Intolerance to Metformin
Item
have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin
boolean
C0020517 (UMLS CUI [1,1])
C0977811 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0977811 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0907402 (UMLS CUI [3,2])
C1744706 (UMLS CUI [4,1])
C0907402 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0025598 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0025598 (UMLS CUI [6,2])
plasma creatinine measurement | Gender | Metformin | Oral hypoglycemics
Item
have plasma creatinine greater than or equal to 1.5 mg/dl (for males) or greater than or equal to 1.4 mg/dl (for females) for patients who will be treated with metformin or; greater than 2 mg/dl for patients treated with other oams, as determined by a local laboratory
boolean
C1278055 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C0359086 (UMLS CUI [4])
Systemic Glucocorticoids chronic | Preparations topical | Inhaled drugs
Item
have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to visit 1
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
C0556393 (UMLS CUI [3])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial