ID

25534

Description

Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00474838

Link

https://clinicaltrials.gov/show/NCT00474838

Keywords

Versions (1)
  1. 9/5/17 9/5/17 -
Uploaded on

September 5, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00474838

English

Eligibility Type 2 Diabetes Mellitus NCT00474838

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed drug naïve type 2 diabetic patient with typical diabetic symptom (polydipsia, polyuria, unexplained weight loss) within recent 1 year
Description

Therapy naive Non-Insulin-Dependent Diabetes Mellitus | Symptoms Diabetic | Polydipsia | Polyuria | Unexplained weight loss

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0011860
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0241863
UMLS CUI [3]
C0085602
UMLS CUI [4]
C0032617
UMLS CUI [5]
C1828173
initial hba1c : 8.0 % ≤ hba1c < 12.0%
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known contraindication to insulin glargine, insulin glulisine, metformin, glimepiride
Description

Medical contraindication Insulin Glargine | Medical contraindication Insulin Glulisine | Medical contraindication Metformin | Medical contraindication glimepiride

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0907402
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1313386
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0025598
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0061323
patients with proliferative diabetic retinopathy
Description

Proliferative diabetic retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0154830
severe liver disease or ast, alt ≥ 2.5 x uln
Description

Liver disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
history of lactic acidosis
Description

Acidosis, Lactic

Data type

boolean

Alias
UMLS CUI [1]
C0001125
unstable or severe angina
Description

Angina, Unstable | Angina Pectoris Severe

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205082
congestive heart failure
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
chronic disease treated with continuous corticosteroid therapy
Description

Steroid therapy Chronic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0008679
diagnosis of cancer
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
positive urine pregnancy test or plan to become pregnant during the clinical trial
Description

Urine pregnancy test positive | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0430059
UMLS CUI [2]
C0032992
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00474838

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Therapy naive Non-Insulin-Dependent Diabetes Mellitus | Symptoms Diabetic | Polydipsia | Polyuria | Unexplained weight loss
Item
newly diagnosed drug naïve type 2 diabetic patient with typical diabetic symptom (polydipsia, polyuria, unexplained weight loss) within recent 1 year
boolean
C0919936 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0241863 (UMLS CUI [2,2])
C0085602 (UMLS CUI [3])
C0032617 (UMLS CUI [4])
C1828173 (UMLS CUI [5])
Glycosylated hemoglobin A
Item
initial hba1c : 8.0 % ≤ hba1c < 12.0%
boolean
C0019018 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Insulin Glargine | Medical contraindication Insulin Glulisine | Medical contraindication Metformin | Medical contraindication glimepiride
Item
known contraindication to insulin glargine, insulin glulisine, metformin, glimepiride
boolean
C1301624 (UMLS CUI [1,1])
C0907402 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1313386 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0061323 (UMLS CUI [4,2])
Proliferative diabetic retinopathy
Item
patients with proliferative diabetic retinopathy
boolean
C0154830 (UMLS CUI [1])
Liver disease Severe | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
severe liver disease or ast, alt ≥ 2.5 x uln
boolean
C0023895 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Acidosis, Lactic
Item
history of lactic acidosis
boolean
C0001125 (UMLS CUI [1])
Angina, Unstable | Angina Pectoris Severe
Item
unstable or severe angina
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Congestive heart failure
Item
congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Steroid therapy Chronic disease
Item
chronic disease treated with continuous corticosteroid therapy
boolean
C0149783 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
Malignant Neoplasms
Item
diagnosis of cancer
boolean
C0006826 (UMLS CUI [1])
Urine pregnancy test positive | Pregnancy, Planned
Item
positive urine pregnancy test or plan to become pregnant during the clinical trial
boolean
C0430059 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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