ID

42568

Description

Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00825253

Link

https://clinicaltrials.gov/show/NCT00825253

Keywords

Versions (2)
  1. 3/10/18 3/10/18 -
  2. 9/2/21 9/2/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 2, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT00825253

English

Eligibility Diabetes NCT00825253

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00825253
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject)
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
type 2 diabetes mellitus diagnosed for at least 12 months prior to screening
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c value between 7% and 10.5% (both inclusive) at screening
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
any insulin treatment for at least 3 months prior to screening
Description

Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0557978
body mass index (bmi): 25 - 40 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any oral antidiabetic agent within the past 6 months
Description

Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
Description

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
cardiac disease: nyha class iii or iv chronic heart failure (chf), unstable angina, and/or any myocardial infarction (treated or untreated) within 6 months prior to screening
Description

Heart Diseases | Chronic heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction Treated | Myocardial Infarction untreated

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0264716
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0027051
UMLS CUI [5,2]
C0332155
hepatic insufficiency (alt or ast greater than or equal to 2 times the central laboratory's upper reference limit)
Description

Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
renal insufficiency (serum creatinine greater than or equal to 1.6 mg/dl for males; greater than or equal to
Description

Renal Insufficiency | Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
recurrent hypoglycaemia or hypoglycaemic unawareness
Description

Recurrent hypoglycemia | Loss of hypoglycemic warning

Data type

boolean

Alias
UMLS CUI [1]
C1846288
UMLS CUI [2]
C0342317
anaemia (haemoglobin less than 13.0 mg/dl in males and less than 12.0 mg/dl in females) (who criteria)
Description

Anemia | Hemoglobin measurement | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0079399
use of any systemic or topical medications (prescribed or non-prescribed) which may alter glucose metabolism (other than insulin products), including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
Description

Pharmaceutical Preparations Systemic Changing Glucose metabolism | Topical preparations prescribed Changing Glucose metabolism | Non-Prescription Drugs Systemic Changing Glucose metabolism | Non-Prescription Drugs Topical Changing Glucose metabolism | Exception Insulin | Glucocorticoids, Systemic | Glucocorticoids Inhalation | Anabolic steroids | Non-selective beta-blocking agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0392747
UMLS CUI [1,4]
C0596620
UMLS CUI [2,1]
C2367813
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0596620
UMLS CUI [3,1]
C0013231
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C0392747
UMLS CUI [3,4]
C0596620
UMLS CUI [4,1]
C0013231
UMLS CUI [4,2]
C1710439
UMLS CUI [4,3]
C0392747
UMLS CUI [4,4]
C0596620
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0021641
UMLS CUI [6]
C3540777
UMLS CUI [7,1]
C0017710
UMLS CUI [7,2]
C0205535
UMLS CUI [8]
C0002845
UMLS CUI [9]
C0304515
history of substance (e.g. drugs, alcohol) abuse or a positive result in the urine drug/alcohol screen or consumption of more than 14 units (women) or 21 units (men) of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, one glass of wine, or 20 ml spirits)
Description

Substance Use Disorders | Urine drug screen positive | Alcohol consumption Alcohol units/week

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0743300
UMLS CUI [3,1]
C0001948
UMLS CUI [3,2]
C0560579
smoking of more than 20 cigarettes per day and inability to refrain from smoking during the in-house period
Description

Tobacco use Number of cigarettes per day | Refrain from Smoking Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
UMLS CUI [2,1]
C4086797
UMLS CUI [2,2]
C1299582
known hepatitis or positive serological tests for the hepatitis b surface antigen (hbsag) or hepatitis c antibodies or hiv antibodies
Description

Hepatitis | Hepatitis B surface antigen positive | Hepatitis C antibody test positive | HIV antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1277805
UMLS CUI [4]
C0920548
uncontrolled treated/untreated hypertension (systolic blood pressure greater than or equal to 160 mmhg and/or diastolic blood pressure greater than or equal to 95 mmhg)
Description

Uncontrolled hypertension Treated | Uncontrolled hypertension untreated | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
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Similar models

Eligibility Diabetes NCT00825253

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00825253
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject)
boolean
C0021430 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus diagnosed for at least 12 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
hba1c value between 7% and 10.5% (both inclusive) at screening
boolean
C0202054 (UMLS CUI [1])
Insulin regime
Item
any insulin treatment for at least 3 months prior to screening
boolean
C0557978 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi): 25 - 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral
Item
use of any oral antidiabetic agent within the past 6 months
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Heart Diseases | Chronic heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction Treated | Myocardial Infarction untreated
Item
cardiac disease: nyha class iii or iv chronic heart failure (chf), unstable angina, and/or any myocardial infarction (treated or untreated) within 6 months prior to screening
boolean
C0018799 (UMLS CUI [1])
C0264716 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
hepatic insufficiency (alt or ast greater than or equal to 2 times the central laboratory's upper reference limit)
boolean
C1306571 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
renal insufficiency (serum creatinine greater than or equal to 1.6 mg/dl for males; greater than or equal to
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Recurrent hypoglycemia | Loss of hypoglycemic warning
Item
recurrent hypoglycaemia or hypoglycaemic unawareness
boolean
C1846288 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Anemia | Hemoglobin measurement | Gender
Item
anaemia (haemoglobin less than 13.0 mg/dl in males and less than 12.0 mg/dl in females) (who criteria)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Pharmaceutical Preparations Systemic Changing Glucose metabolism | Topical preparations prescribed Changing Glucose metabolism | Non-Prescription Drugs Systemic Changing Glucose metabolism | Non-Prescription Drugs Topical Changing Glucose metabolism | Exception Insulin | Glucocorticoids, Systemic | Glucocorticoids Inhalation | Anabolic steroids | Non-selective beta-blocking agent
Item
use of any systemic or topical medications (prescribed or non-prescribed) which may alter glucose metabolism (other than insulin products), including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
boolean
C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C0596620 (UMLS CUI [1,4])
C2367813 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C0013231 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0392747 (UMLS CUI [3,3])
C0596620 (UMLS CUI [3,4])
C0013231 (UMLS CUI [4,1])
C1710439 (UMLS CUI [4,2])
C0392747 (UMLS CUI [4,3])
C0596620 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0021641 (UMLS CUI [5,2])
C3540777 (UMLS CUI [6])
C0017710 (UMLS CUI [7,1])
C0205535 (UMLS CUI [7,2])
C0002845 (UMLS CUI [8])
C0304515 (UMLS CUI [9])
Substance Use Disorders | Urine drug screen positive | Alcohol consumption Alcohol units/week
Item
history of substance (e.g. drugs, alcohol) abuse or a positive result in the urine drug/alcohol screen or consumption of more than 14 units (women) or 21 units (men) of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, one glass of wine, or 20 ml spirits)
boolean
C0038586 (UMLS CUI [1])
C0743300 (UMLS CUI [2])
C0001948 (UMLS CUI [3,1])
C0560579 (UMLS CUI [3,2])
Tobacco use Number of cigarettes per day | Refrain from Smoking Unable
Item
smoking of more than 20 cigarettes per day and inability to refrain from smoking during the in-house period
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C4086797 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Hepatitis | Hepatitis B surface antigen positive | Hepatitis C antibody test positive | HIV antibody positive
Item
known hepatitis or positive serological tests for the hepatitis b surface antigen (hbsag) or hepatitis c antibodies or hiv antibodies
boolean
C0019158 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1277805 (UMLS CUI [3])
C0920548 (UMLS CUI [4])
Uncontrolled hypertension Treated | Uncontrolled hypertension untreated | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled treated/untreated hypertension (systolic blood pressure greater than or equal to 160 mmhg and/or diastolic blood pressure greater than or equal to 95 mmhg)
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
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