ID

19388

Description

Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00330330

Link

https://clinicaltrials.gov/show/NCT00330330

Keywords

Versions (1)
  1. 12/28/16 12/28/16 -
Uploaded on

December 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00330330

English

Eligibility Type 2 Diabetes Mellitus NCT00330330

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus of less than 5 years in duration
Description

Non-Insulin-Dependent Diabetes Mellitus disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
have never received hypoglycemic therapy
Description

Hypoglycemia untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0332155
aged 18 to 65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
fasting blood glucose between 130 and 220 mg/dl (7.2 to 12.2 mmol/l) for cohorts a-d and between 140 and 220 mg/dl (7.8 to 12.2 mmol/l) for cohort e
Description

Fasting blood glucose measurement Cohort Roman letter

Data type

boolean

Alias
UMLS CUI [1,1]
C0428568
UMLS CUI [1,2]
C0599755
UMLS CUI [1,3]
C0439102
hba1c between 6.8 and 10.0% for cohorts a-d and between 7.5 and 11.0% for cohort e
Description

Glucohemoglobin measurement Cohort Roman letter

Data type

boolean

Alias
UMLS CUI [1,1]
C0202054
UMLS CUI [1,2]
C0599755
UMLS CUI [1,3]
C0439102
body mass index > 25 and < 35 kg m -2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
medication that may affect glucose homeostasis (e.g. systemic glucocorticoid) within one month of screening
Description

Pharmaceutical Preparations Affecting Glucose homeostasis | Glucocorticoids Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1326961
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C0205373
clinically significant abnormalities in medical history or physical exam
Description

Medical History Abnormality Clinical Significance | Physical examination abnormal Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2826293
UMLS CUI [2,1]
C0747585
UMLS CUI [2,2]
C2826293
clinically significant abnormalities on laboratory examination
Description

Laboratory examination Abnormality Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0260877
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2826293
history of hiv infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
active infection requiring antiviral or antimicrobial therapy
Description

Communicable Disease Requirement Antiviral Therapy | Communicable Disease Requirement Therapeutic procedure Antimicrobial medicament

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0280274
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0443071
malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > one year at the time of screening)
Description

Malignant Neoplasms | Basal cell carcinoma Treated Adequate | Squamous cell carcinoma of skin Treated Adequate

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205411
any other concurrent condition which, in the opinion of the investigator, would preclude participation in or interfere with compliance
Description

Comorbidity Study Subject Participation Status Exclusion | Comorbidity Interferes with Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1321605
alcohol or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days of screening
Description

Investigational New Drugs | Biological Factors | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0005515
UMLS CUI [3]
C2346570
abnormal serum creatinine concentration defined as > 1.5 mg/dl (132.6 micro mol/l) for males and > 1.2 mg/dl (106 micro mol/l) for females
Description

Serum creatinine abnormal | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0438243
UMLS CUI [2]
C0079399
medications that may affect coagulation (heparin, warfarin, etc.) with the exception of acetylsalicylic acid or non-steroidal anti-inflammatory agents.
Description

Pharmaceutical Preparations Affecting Coagulation | Heparin | Warfarin | Aspirin | Anti-Inflammatory Agents, Non-Steroidal

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005778
UMLS CUI [2]
C0019134
UMLS CUI [3]
C0043031
UMLS CUI [4]
C0004057
UMLS CUI [5]
C0003211
allergy to sulfur-containing medications
Description

Sulfur allergy

Data type

boolean

Alias
UMLS CUI [1]
C0571095
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00330330

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
type 2 diabetes mellitus of less than 5 years in duration
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hypoglycemia untreated
Item
have never received hypoglycemic therapy
boolean
C0020615 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Age
Item
aged 18 to 65 years
boolean
C0001779 (UMLS CUI [1])
Fasting blood glucose measurement Cohort Roman letter
Item
fasting blood glucose between 130 and 220 mg/dl (7.2 to 12.2 mmol/l) for cohorts a-d and between 140 and 220 mg/dl (7.8 to 12.2 mmol/l) for cohort e
boolean
C0428568 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
Glucohemoglobin measurement Cohort Roman letter
Item
hba1c between 6.8 and 10.0% for cohorts a-d and between 7.5 and 11.0% for cohort e
boolean
C0202054 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
C0439102 (UMLS CUI [1,3])
Body mass index
Item
body mass index > 25 and < 35 kg m -2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Affecting Glucose homeostasis | Glucocorticoids Systemic
Item
medication that may affect glucose homeostasis (e.g. systemic glucocorticoid) within one month of screening
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1326961 (UMLS CUI [1,3])
C0017710 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
Medical History Abnormality Clinical Significance | Physical examination abnormal Clinical Significance
Item
clinically significant abnormalities in medical history or physical exam
boolean
C0262926 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0747585 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Laboratory examination Abnormality Clinical Significance
Item
clinically significant abnormalities on laboratory examination
boolean
C0260877 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
HIV Infection
Item
history of hiv infection
boolean
C0019693 (UMLS CUI [1])
Communicable Disease Requirement Antiviral Therapy | Communicable Disease Requirement Therapeutic procedure Antimicrobial medicament
Item
active infection requiring antiviral or antimicrobial therapy
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0280274 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0443071 (UMLS CUI [2,4])
Malignant Neoplasms | Basal cell carcinoma Treated Adequate | Squamous cell carcinoma of skin Treated Adequate
Item
malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > one year at the time of screening)
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
Comorbidity Study Subject Participation Status Exclusion | Comorbidity Interferes with Compliance behavior
Item
any other concurrent condition which, in the opinion of the investigator, would preclude participation in or interfere with compliance
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
Substance Use Disorders
Item
alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Investigational New Drugs | Biological Factors | Investigational Medical Device
Item
undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days of screening
boolean
C0013230 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Serum creatinine abnormal | Gender
Item
abnormal serum creatinine concentration defined as > 1.5 mg/dl (132.6 micro mol/l) for males and > 1.2 mg/dl (106 micro mol/l) for females
boolean
C0438243 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Pharmaceutical Preparations Affecting Coagulation | Heparin | Warfarin | Aspirin | Anti-Inflammatory Agents, Non-Steroidal
Item
medications that may affect coagulation (heparin, warfarin, etc.) with the exception of acetylsalicylic acid or non-steroidal anti-inflammatory agents.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005778 (UMLS CUI [1,3])
C0019134 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0004057 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
Sulfur allergy
Item
allergy to sulfur-containing medications
boolean
C0571095 (UMLS CUI [1])
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