ID

17151

Descripción

Insulin Analogue With Continuous Glucose Monitoring System (CGMS) Measurement; ODM derived from: https://clinicaltrials.gov/show/NCT00354939

Link

https://clinicaltrials.gov/show/NCT00354939

Palabras clave

Versiones (1)
  1. 29/8/16 29/8/16 -
Subido en

29 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type 2 NCT00354939

Inglés

Eligibility Diabetes Mellitus Type 2 NCT00354939

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 diabetes mellitus (no history of ketoacidosis)and stable treatment with nph insulin(once or twice daily)and mealtime insulin for at least 3 months.
Descripción

Diabetes Mellitus, Non-Insulin-Dependent | Ketosis | insulin, isophane | Insulin Mealtime | Therapeutic procedure Stable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0022638
UMLS CUI [3]
C0021658
UMLS CUI [4,1]
C0021641
UMLS CUI [4,2]
C0587119
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0205360
hba1c values smaller/equal 8.0%(measured at screening visit, visit 1).
Descripción

Glycosylated hemoglobin A

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019018
ability and willingness to perform continuous and self monitoring blood glucose profiles, using a self monitoring blood glucose meter as well as carrying the continuous blood glucose meter at least two times for 72 hours throughout the study at home.
Descripción

Blood Glucose Self-Monitoring | Blood glucose meter

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005803
UMLS CUI [2]
C0472226
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
all forms of diabetes other than type 2 diabetes mellitus.
Descripción

Diabetes | Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011847
UMLS CUI [2]
C0011860
oral antidiabetic drugs(oads)and/or insulins other than nph and mealtime insulins, except metformin(stable dose for a minimum of 3 months, no dose adjustments during the study).
Descripción

Oral hypoglycemic | Insulin | insulin, isophane | Insulin Mealtime | Metformin | Dosage Stable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0021658
UMLS CUI [4,1]
C0021641
UMLS CUI [4,2]
C0587119
UMLS CUI [5]
C0025598
UMLS CUI [6,1]
C0178602
UMLS CUI [6,2]
C0205360
pregnant(as determined by urine pregnancy test at visit 1)or breast-feeding.
Descripción

Pregnancy Urine pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430056
women of childbearing potential who did not take adequate contraceptive protection such as systemic hormones or who planned to become pregnant during the study.
Descripción

Childbearing Potential Contraceptive methods Lack | Hormonal Contraceptives, Systemic | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0009907
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0032992
likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. systemic corticosteroids).
Descripción

Illicit drug use Study Protocol Patient need for | systemic steroids

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0281875
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0686904
UMLS CUI [2]
C2825233
history of hypersensitivity to the study medication or to drugs with similar chemical structures.
Descripción

Hypersensitivity Investigational New Drug | Hypersensitivity Investigational New Drug Chemical Structure Similar

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0220807
UMLS CUI [2,4]
C2348205
treatment with any investigational drugs in the last month before study entry.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
history of drug or alcohol abuse.
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which required surgical treatment within the study.
Descripción

Operative Surgical Procedures Diabetic Retinopathy | Laser photocoagulation | Vitrectomy | Operative Surgical Procedures Patient need for

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0011884
UMLS CUI [2]
C0441510
UMLS CUI [3]
C0042903
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0686904
clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult.
Descripción

Cardiovascular Diseases Relevant Clinical | Gastrointestinal Diseases | Liver diseases | nervous system disorder | Endocrine System Diseases | Hematological Disease | Systemic disease Major Interferes with Study Protocol | Systemic disease Major Interferes with research results

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0014130
UMLS CUI [6]
C0018939
UMLS CUI [7,1]
C0442893
UMLS CUI [7,2]
C0205164
UMLS CUI [7,3]
C0521102
UMLS CUI [7,4]
C2348563
UMLS CUI [8,1]
C0442893
UMLS CUI [8,2]
C0205164
UMLS CUI [8,3]
C0521102
UMLS CUI [8,4]
C0683954
known impaired hepatic or renal function.
Descripción

Hepatic Insufficiency | Renal Insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C1565489
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Diabetes Mellitus Type 2 NCT00354939

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Ketosis | insulin, isophane | Insulin Mealtime | Therapeutic procedure Stable
Item
subjects with type 2 diabetes mellitus (no history of ketoacidosis)and stable treatment with nph insulin(once or twice daily)and mealtime insulin for at least 3 months.
boolean
C0011860 (UMLS CUI [1])
C0022638 (UMLS CUI [2])
C0021658 (UMLS CUI [3])
C0021641 (UMLS CUI [4,1])
C0587119 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
Glycosylated hemoglobin A
Item
hba1c values smaller/equal 8.0%(measured at screening visit, visit 1).
boolean
C0019018 (UMLS CUI [1])
Blood Glucose Self-Monitoring | Blood glucose meter
Item
ability and willingness to perform continuous and self monitoring blood glucose profiles, using a self monitoring blood glucose meter as well as carrying the continuous blood glucose meter at least two times for 72 hours throughout the study at home.
boolean
C0005803 (UMLS CUI [1])
C0472226 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diabetes | Diabetes Mellitus, Non-Insulin-Dependent
Item
all forms of diabetes other than type 2 diabetes mellitus.
boolean
C0011847 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Oral hypoglycemic | Insulin | insulin, isophane | Insulin Mealtime | Metformin | Dosage Stable
Item
oral antidiabetic drugs(oads)and/or insulins other than nph and mealtime insulins, except metformin(stable dose for a minimum of 3 months, no dose adjustments during the study).
boolean
C0359086 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0021658 (UMLS CUI [3])
C0021641 (UMLS CUI [4,1])
C0587119 (UMLS CUI [4,2])
C0025598 (UMLS CUI [5])
C0178602 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
Pregnancy Urine pregnancy test
Item
pregnant(as determined by urine pregnancy test at visit 1)or breast-feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Lack | Hormonal Contraceptives, Systemic | Pregnancy, Planned
Item
women of childbearing potential who did not take adequate contraceptive protection such as systemic hormones or who planned to become pregnant during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0009907 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3])
Illicit drug use Study Protocol Patient need for | systemic steroids
Item
likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. systemic corticosteroids).
boolean
C0281875 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C2825233 (UMLS CUI [2])
Hypersensitivity Investigational New Drug | Hypersensitivity Investigational New Drug Chemical Structure Similar
Item
history of hypersensitivity to the study medication or to drugs with similar chemical structures.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Investigational New Drugs
Item
treatment with any investigational drugs in the last month before study entry.
boolean
C0013230 (UMLS CUI [1])
Substance Use Disorders
Item
history of drug or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
Operative Surgical Procedures Diabetic Retinopathy | Laser photocoagulation | Vitrectomy | Operative Surgical Procedures Patient need for
Item
diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which required surgical treatment within the study.
boolean
C0543467 (UMLS CUI [1,1])
C0011884 (UMLS CUI [1,2])
C0441510 (UMLS CUI [2])
C0042903 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
Cardiovascular Diseases Relevant Clinical | Gastrointestinal Diseases | Liver diseases | nervous system disorder | Endocrine System Diseases | Hematological Disease | Systemic disease Major Interferes with Study Protocol | Systemic disease Major Interferes with research results
Item
clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult.
boolean
C0007222 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0018939 (UMLS CUI [6])
C0442893 (UMLS CUI [7,1])
C0205164 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C2348563 (UMLS CUI [7,4])
C0442893 (UMLS CUI [8,1])
C0205164 (UMLS CUI [8,2])
C0521102 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
Hepatic Insufficiency | Renal Insufficiency
Item
known impaired hepatic or renal function.
boolean
C1306571 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Study Subject Participation Status
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])
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