ID

42567

Beschreibung

Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 and Insulin Glargine and Insulin Glulisine Therapy in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00824668

Link

https://clinicaltrials.gov/show/NCT00824668

Stichworte

Versionen (2)
  1. 10.03.18 10.03.18 -
  2. 02.09.21 02.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes NCT00824668

Englisch

Eligibility Diabetes NCT00824668

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00824668
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus for 12 months or longer
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
body mass index (bmi): 25.0-40.0 kg/m2, both inclusive
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
hba1c between 7.0 and 10.5% at screening
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
insulin treatment for at least 3 months prior to screening with a total daily dose of 0.6 and 0.9 u/kg body weight
Beschreibung

Insulin regime U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0456683
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any oral antidiabetic agent within the past 2 months
Beschreibung

Antidiabetics Oral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
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
Beschreibung

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

Datentyp

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 (alanine aminotransferase (alt) or aspartate aminotransferase (ast) equal to or greater than 2 times the central laboratory's upper reference limit)
Beschreibung

Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
renal insufficiency (serum creatinine equal to or greater than 1.6 mg/dl for males; equal to or greater than 1.4 mg/dl for females)
Beschreibung

Renal Insufficiency | Creatinine measurement, serum | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
recurrent hypoglycaemia
Beschreibung

Recurrent hypoglycemia

Datentyp

boolean

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

Anemia | Hemoglobin measurement | Gender

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0596620
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0596620
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0021641
UMLS CUI [4]
C3540777
UMLS CUI [5,1]
C0017710
UMLS CUI [5,2]
C0205535
UMLS CUI [6]
C0002845
UMLS CUI [7]
C0304515
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Ähnliche Modelle

Eligibility Diabetes NCT00824668

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00824668
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus for 12 months or longer
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Body mass index
Item
body mass index (bmi): 25.0-40.0 kg/m2, both inclusive
boolean
C1305855 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c between 7.0 and 10.5% at screening
boolean
C0202054 (UMLS CUI [1])
Insulin regime U/day
Item
insulin treatment for at least 3 months prior to screening with a total daily dose of 0.6 and 0.9 u/kg body weight
boolean
C0557978 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Antidiabetics Oral
Item
use of any oral antidiabetic agent within the past 2 months
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
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 (alanine aminotransferase (alt) or aspartate aminotransferase (ast) equal to or greater than 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 equal to or greater than 1.6 mg/dl for males; equal to or greater than 1.4 mg/dl for females)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Recurrent hypoglycemia
Item
recurrent hypoglycaemia
boolean
C1846288 (UMLS CUI [1])
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 Changing Glucose metabolism | Non-Prescription Drugs Changing Glucose metabolism | Exception Insulin | Glucocorticoids, Systemic | Glucocorticoids Inhalation | Anabolic steroids | Non-selective beta-blocking agent
Item
use of concomitant medications (prescribed or non-prescribed and other than insulin) which may alter glucose metabolism including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C0013231 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C3540777 (UMLS CUI [4])
C0017710 (UMLS CUI [5,1])
C0205535 (UMLS CUI [5,2])
C0002845 (UMLS CUI [6])
C0304515 (UMLS CUI [7])
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