ID

19440

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00551538

Stichworte

Versionen (1)
  1. 02.01.17 02.01.17 -
Hochgeladen am

2. Januar 2017

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00551538

Englisch

Eligibility Type 2 Diabetes NCT00551538

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

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
Beschreibung

Poor glycemic control | Glucohemoglobin measurement

Datentyp

boolean

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

Use of

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Insulin Once daily | Insulin Twice a day

Datentyp

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.
Beschreibung

Combination Pharmaceutical Preparations enumerated

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

Capability | Willing

Datentyp

boolean

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

Compliance with prescribed diet | Compliance behavior to prescribed medication

Datentyp

boolean

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

Blood Glucose Self-Monitoring

Datentyp

boolean

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

Study Protocol Subject Diary Use of

Datentyp

boolean

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

Inpatient Assessment 24 Hours | Participation Assessment Two

Datentyp

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
Beschreibung

Exclusion Criteria

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

Thiazolidinediones | pioglitazone | rosiglitazone

Datentyp

boolean

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

Meglitinide | Sulfonylurea

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

plasma creatinine measurement | Gender | Metformin | Oral hypoglycemics

Datentyp

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
Beschreibung

Systemic Glucocorticoids chronic | Preparations topical | Inhaled drugs

Datentyp

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
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Ähnliche Modelle

Eligibility Type 2 Diabetes NCT00551538

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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