ID

32981

Description

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

Keywords

Versions (1)
  1. 11/22/18 11/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 22, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes Mellitus NCT01159353

English

Eligibility Type 2 Diabetes Mellitus NCT01159353

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

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

Antidiabetics Oral

Data type

boolean

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

C-peptide measurement

Data type

boolean

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

Body mass index

Data type

boolean

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

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type i diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

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

Insulin regime

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Pharmaceutical Preparations Influence Insulin Sensitivity

Data type

boolean

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

CORTICOSTEROIDS FOR SYSTEMIC USE

Data type

boolean

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

Complications Metabolic

Data type

boolean

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

Recurrent severe hypoglycemia | Hypoglycaemia unawareness

Data type

boolean

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

Proliferative diabetic retinopathy | Diabetic gastroparesis

Data type

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
Description

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Insulin allergy | Hypersensitivity Insulin Analog

Data type

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.
Description

Study Subject Participation Status Considerations Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0518609
UMLS CUI [1,3]
C1524062
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT01159353

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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