ID

23247

Description

Effects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT00330200

Link

https://clinicaltrials.gov/show/NCT00330200

Keywords

Versions (1)
  1. 6/30/17 6/30/17 -
Uploaded on

June 30, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00330200

English

Eligibility Type 2 Diabetes Mellitus NCT00330200

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female (post menopausal and/or surgically sterile)
Description

Gender | Postmenopausal state | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
aged 18 to 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
treatment naïve subjects with fasting blood glucose levels of 150-220 mg/dl, hematocrit of >/= 35% and hba1c levels of >/= 7% and </= 10.0%
Description

Therapy naive | Fasting blood glucose measurement | Hematocrit procedure | Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0428568
UMLS CUI [3]
C0018935
UMLS CUI [4]
C0019018
subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dl, hematocrit of >/= 35%, and hba1c levels of >/= 6.5% and </= 9.0%
Description

Antidiabetics | Fasting blood glucose measurement | Hematocrit procedure | Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0428568
UMLS CUI [3]
C0018935
UMLS CUI [4]
C0019018
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
greater than 3 severe hypoglycemic episodes within six months of screen
Description

Hypoglycaemic episode Severe Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1265611
pregnant, breastfeeding, or intends to become pregnant
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alt greater than 1.5 times the upper limit of normal
Description

Sign or Symptom Liver diseases | Hepatitis | Hepatitis, Chronic | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0019189
UMLS CUI [4]
C0151905
history of hepatitis b surface antigen, hepatitis c antibody, or hiv
Description

Hepatitis B Surface Antigens | Hepatitis C Antibodies | HIV Infections

Data type

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0166049
UMLS CUI [3]
C0019693
complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
Description

Complications of Diabetes Mellitus | Neuropathy | Kidney Diseases | Retinal Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0442874
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0035309
clinically significant and currently active diseases
Description

Disease Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
clinically significant abnormalities in medical history, physical examination, or laboratory examination
Description

Abnormality Medical History | Abnormality Physical Examination | Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0031809
UMLS CUI [3]
C0438215
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00330200

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Postmenopausal state | Female Sterilization
Item
male or female (post menopausal and/or surgically sterile)
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Age
Item
aged 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
Therapy naive | Fasting blood glucose measurement | Hematocrit procedure | Glycosylated hemoglobin A
Item
treatment naïve subjects with fasting blood glucose levels of 150-220 mg/dl, hematocrit of >/= 35% and hba1c levels of >/= 7% and </= 10.0%
boolean
C0919936 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
C0018935 (UMLS CUI [3])
C0019018 (UMLS CUI [4])
Antidiabetics | Fasting blood glucose measurement | Hematocrit procedure | Glycosylated hemoglobin A
Item
subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dl, hematocrit of >/= 35%, and hba1c levels of >/= 6.5% and </= 9.0%
boolean
C0935929 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
C0018935 (UMLS CUI [3])
C0019018 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Hypoglycaemic episode Severe Quantity
Item
greater than 3 severe hypoglycemic episodes within six months of screen
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant, breastfeeding, or intends to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Sign or Symptom Liver diseases | Hepatitis | Hepatitis, Chronic | Alanine aminotransferase increased
Item
clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alt greater than 1.5 times the upper limit of normal
boolean
C3540840 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0019158 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
Hepatitis B Surface Antigens | Hepatitis C Antibodies | HIV Infections
Item
history of hepatitis b surface antigen, hepatitis c antibody, or hiv
boolean
C0019168 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Complications of Diabetes Mellitus | Neuropathy | Kidney Diseases | Retinal Diseases
Item
complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
boolean
C0342257 (UMLS CUI [1])
C0442874 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0035309 (UMLS CUI [4])
Disease Clinical Significance
Item
clinically significant and currently active diseases
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Abnormality Medical History | Abnormality Physical Examination | Laboratory test result abnormal
Item
clinically significant abnormalities in medical history, physical examination, or laboratory examination
boolean
C1704258 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0438215 (UMLS CUI [3])
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