ID

29193

Description

A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00971997

Link

https://clinicaltrials.gov/show/NCT00971997

Keywords

Versions (1)
  1. 3/6/18 3/6/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 6, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00971997

English

Eligibility Diabetes Mellitus, Type 2 NCT00971997

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed as having type 2 diabetes.
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
patients who have not been on insulin treatment within 6 months.
Description

Insulin regime Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0332197
patients who have been taking oads for at least 90 days.
Description

Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
patients with an hba1c level in the range of 7.5% to 11.0%.
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
patients with a body-mass index (bmi) of 35 kg/m² or below.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment).
Description

Preproliferative diabetic retinopathy | Proliferative retinopathy | Exception Retinal Disease No treatment required for

Data type

boolean

Alias
UMLS CUI [1]
C0339473
UMLS CUI [2]
C0339467
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0035309
UMLS CUI [3,3]
C0332126
patients having or suspected of having malignancy
Description

Malignant Neoplasms | Malignant Neoplasms Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0750491
patients having serious complications of the heart, liver, or kidney.
Description

Cardiac complication Serious | Hepatic complications Serious | Kidney complications Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0161816
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C1832055
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C1408259
UMLS CUI [3,2]
C0205404
patients hypersensitive or allergic to insulin or insulin analog preparations or a history of it.
Description

Insulin allergy | Hypersensitivity Insulin Analog

Data type

boolean

Alias
UMLS CUI [1]
C0571622
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2825028
patients receiving systemic steroids.
Description

Systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C2825233
are currently enrolled in a clinical trial of a non-approved drug. or patients who participated in other clinical trials including post-marketing clinical trials within 90 days prior to informed consent being obtained.
Description

Study Subject Participation Status | Drugs, Non-Prescription | Post marketing study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013231
UMLS CUI [3]
C1548594
patients of child-bearing potential. breastfeeding patients. patients with a positive result in a pregnancy test performed for women of child-bearing potential.
Description

Childbearing Potential | Breast Feeding | Childbearing Potential Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0240802
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00971997

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients diagnosed as having type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Insulin regime Absent
Item
patients who have not been on insulin treatment within 6 months.
boolean
C0557978 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Antidiabetics Oral
Item
patients who have been taking oads for at least 90 days.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
patients with an hba1c level in the range of 7.5% to 11.0%.
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
patients with a body-mass index (bmi) of 35 kg/m² or below.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Preproliferative diabetic retinopathy | Proliferative retinopathy | Exception Retinal Disease No treatment required for
Item
patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment).
boolean
C0339473 (UMLS CUI [1])
C0339467 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0035309 (UMLS CUI [3,2])
C0332126 (UMLS CUI [3,3])
Malignant Neoplasms | Malignant Neoplasms Suspected
Item
patients having or suspected of having malignancy
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Cardiac complication Serious | Hepatic complications Serious | Kidney complications Serious
Item
patients having serious complications of the heart, liver, or kidney.
boolean
C0161816 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1832055 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1408259 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
Insulin allergy | Hypersensitivity Insulin Analog
Item
patients hypersensitive or allergic to insulin or insulin analog preparations or a history of it.
boolean
C0571622 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C2825028 (UMLS CUI [2,2])
Systemic steroids
Item
patients receiving systemic steroids.
boolean
C2825233 (UMLS CUI [1])
Study Subject Participation Status | Drugs, Non-Prescription | Post marketing study
Item
are currently enrolled in a clinical trial of a non-approved drug. or patients who participated in other clinical trials including post-marketing clinical trials within 90 days prior to informed consent being obtained.
boolean
C2348568 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C1548594 (UMLS CUI [3])
Childbearing Potential | Breast Feeding | Childbearing Potential Pregnancy test positive
Item
patients of child-bearing potential. breastfeeding patients. patients with a positive result in a pregnancy test performed for women of child-bearing potential.
boolean
C3831118 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0240802 (UMLS CUI [3,2])
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