ID

32981

Beschrijving

Pharmacodynamic and Pharmacokinetic Effects of Insulin Glulisine in Obese Subjects With Type 2 Diabetes After a Standard Meal in Comparison to Insulin Aspart; ODM derived from: https://clinicaltrials.gov/show/NCT01159353

Link

https://clinicaltrials.gov/show/NCT01159353

Trefwoorden

Versies (1)
  1. 22-11-18 22-11-18 -
Houder van rechten

See clinicaltrials.gov

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22 november 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01159353

Engels

Eligibility Type 2 Diabetes Mellitus NCT01159353

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes for at least one year
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treated with oral antidiabetic agents (oads) for at least 6 months
Beschrijving

Antidiabetics Oral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
baseline c-peptide ≥0.1 nmol/l
Beschrijving

C-peptide measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202100
bmi (body mass index) between 30 and 40 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
hba1c (glycosylated hemoglobin) < 8.5%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
type i diabetes mellitus
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
current treatment with insulin
Beschrijving

Insulin regime

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
pregnant and breast-feeding women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
any medication known to influence insulin sensitivity
Beschrijving

Pharmaceutical Preparations Influence Insulin Sensitivity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0920563
current treatment with systemic corticosteroids
Beschrijving

CORTICOSTEROIDS FOR SYSTEMIC USE

Datatype

boolean

Alias
UMLS CUI [1]
C3653708
history of acute metabolic complications in the past 3 months
Beschrijving

Complications Metabolic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0311400
recurrent severe hypoglycaemia or hypoglycaemic unawareness
Beschrijving

Recurrent severe hypoglycemia | Hypoglycaemia unawareness

Datatype

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
active proliferative diabetic retinopathy and known diabetic gastroparesis
Beschrijving

Proliferative diabetic retinopathy | Diabetic gastroparesis

Datatype

boolean

Alias
UMLS CUI [1]
C0154830
UMLS CUI [2]
C0267176
impaired hepatic function, as shown but not limited to alt or ast above 2 times the upper limit of normal
Beschrijving

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
clinically relevant illness such as nephropathy and impaired renal function as shown by clearance < 30 ml/min
Beschrijving

Illness Relevant Clinical | Kidney Diseases | Renal Insufficiency | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
UMLS CUI [2]
C0022658
UMLS CUI [3]
C1565489
UMLS CUI [4]
C0373595
any history or presence of clinically relevant abnormality, medical condition (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease; any acute infectious disease or signs of acute illness making implementation of the protocol or interpretation of the results difficult
Beschrijving

Abnormality Relevant Clinical | Medical condition Relevant Clinical | Cardiovascular Disease | Lung disease | Gastrointestinal Disease | Liver disease | Kidney Disease | Metabolic Disease | Hematological Disease | Nervous system disorder | Mental disorder | Systemic disease | Disorder of eye | Communicable Disease | Acute infectious disease Completion of clinical trial Difficult | Acute infectious disease Interpretation Research results Difficult | Acute illness Completion of clinical trial Difficult | Acute illness Interpretation Research results Difficult

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C0205210
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0023895
UMLS CUI [7]
C0022658
UMLS CUI [8]
C0025517
UMLS CUI [9]
C0018939
UMLS CUI [10]
C0027765
UMLS CUI [11]
C0004936
UMLS CUI [12]
C0442893
UMLS CUI [13]
C0015397
UMLS CUI [14]
C0009450
UMLS CUI [15,1]
C0275518
UMLS CUI [15,2]
C2732579
UMLS CUI [15,3]
C0332218
UMLS CUI [16,1]
C0275518
UMLS CUI [16,2]
C0459471
UMLS CUI [16,3]
C0683954
UMLS CUI [16,4]
C0332218
UMLS CUI [17,1]
C4061114
UMLS CUI [17,2]
C2732579
UMLS CUI [17,3]
C0332218
UMLS CUI [18,1]
C4061114
UMLS CUI [18,2]
C0459471
UMLS CUI [18,3]
C0683954
UMLS CUI [18,4]
C0332218
hypersensitivity to insulins or insulin analogs
Beschrijving

Insulin allergy | Hypersensitivity Insulin Analog

Datatype

boolean

Alias
UMLS CUI [1]
C0571622
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2825028
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschrijving

Study Subject Participation Status Considerations Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0518609
UMLS CUI [1,3]
C1524062
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT01159353

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
patients with type 2 diabetes for at least one year
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Antidiabetics Oral
Item
treated with oral antidiabetic agents (oads) for at least 6 months
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C-peptide measurement
Item
baseline c-peptide ≥0.1 nmol/l
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index) between 30 and 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c (glycosylated hemoglobin) < 8.5%
boolean
C0474680 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type i diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Insulin regime
Item
current treatment with insulin
boolean
C0557978 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant and breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmaceutical Preparations Influence Insulin Sensitivity
Item
any medication known to influence insulin sensitivity
boolean
C0013227 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0920563 (UMLS CUI [1,3])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
current treatment with systemic corticosteroids
boolean
C3653708 (UMLS CUI [1])
Complications Metabolic
Item
history of acute metabolic complications in the past 3 months
boolean
C0009566 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
Recurrent severe hypoglycemia | Hypoglycaemia unawareness
Item
recurrent severe hypoglycaemia or hypoglycaemic unawareness
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Proliferative diabetic retinopathy | Diabetic gastroparesis
Item
active proliferative diabetic retinopathy and known diabetic gastroparesis
boolean
C0154830 (UMLS CUI [1])
C0267176 (UMLS CUI [2])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
impaired hepatic function, as shown but not limited to alt or ast above 2 times the upper limit of normal
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Illness Relevant Clinical | Kidney Diseases | Renal Insufficiency | Creatinine clearance measurement
Item
clinically relevant illness such as nephropathy and impaired renal function as shown by clearance < 30 ml/min
boolean
C0221423 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
Abnormality Relevant Clinical | Medical condition Relevant Clinical | Cardiovascular Disease | Lung disease | Gastrointestinal Disease | Liver disease | Kidney Disease | Metabolic Disease | Hematological Disease | Nervous system disorder | Mental disorder | Systemic disease | Disorder of eye | Communicable Disease | Acute infectious disease Completion of clinical trial Difficult | Acute infectious disease Interpretation Research results Difficult | Acute illness Completion of clinical trial Difficult | Acute illness Interpretation Research results Difficult
Item
any history or presence of clinically relevant abnormality, medical condition (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, ocular or infectious disease; any acute infectious disease or signs of acute illness making implementation of the protocol or interpretation of the results difficult
boolean
C1704258 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
C0007222 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0025517 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0027765 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
C0442893 (UMLS CUI [12])
C0015397 (UMLS CUI [13])
C0009450 (UMLS CUI [14])
C0275518 (UMLS CUI [15,1])
C2732579 (UMLS CUI [15,2])
C0332218 (UMLS CUI [15,3])
C0275518 (UMLS CUI [16,1])
C0459471 (UMLS CUI [16,2])
C0683954 (UMLS CUI [16,3])
C0332218 (UMLS CUI [16,4])
C4061114 (UMLS CUI [17,1])
C2732579 (UMLS CUI [17,2])
C0332218 (UMLS CUI [17,3])
C4061114 (UMLS CUI [18,1])
C0459471 (UMLS CUI [18,2])
C0683954 (UMLS CUI [18,3])
C0332218 (UMLS CUI [18,4])
Insulin allergy | Hypersensitivity Insulin Analog
Item
hypersensitivity to insulins or insulin analogs
boolean
C0571622 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C2825028 (UMLS CUI [2,2])
Study Subject Participation Status Considerations Additional
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 [1,1])
C0518609 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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