ID

31392

Beschreibung

Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00859898

Link

https://clinicaltrials.gov/show/NCT00859898

Stichworte

Versionen (1)
  1. 19.08.18 19.08.18 -
Rechteinhaber

see clinicaltrials.gov

Hochgeladen am

19. August 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Type 2 Diabetes Mellitus NCT00859898

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00859898

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
treatment naive males and females, >= 18 years old and <= 77 years old, with type 2 diabetes mellitus
Beschreibung

Therapy naive; Male Gender, Self Report | Age | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C1706180
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0011860
subjects must have central laboratory pre-randomization hemoglobin a1c >= 7.5 and <= 12.0%
Beschreibung

Hemoglobin A1c measurement; Central Laboratory; Randomization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C1880016
UMLS CUI [1,3]
C0034656
c-peptide >= 1.0 ng/ml (0.34 nmol/l)
Beschreibung

Insulin C-peptide measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202100
body mass index <= 45 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
must be able to perform self monitoring of blood glucose
Beschreibung

Blood Glucose Self-Monitoring; Ability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005803
UMLS CUI [1,2]
C0085732
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) >3x*upper limit of normal (uln)
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum total bilirubin >2 mg/dl (34.2 µmol/l)
Beschreibung

Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1278039
creatinine kinase >3*uln
Beschreibung

Creatine kinase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201973
serum creatinine >= 1.50 mg/dl (133 µmol/l) for male subjects, >= 1.40 mg/dl (124
Beschreibung

Creatinine measurement, serum (procedure) | Male Gender, Self Report

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1706180
µmol/l) for female subjects
Beschreibung

Creatinine measurement, serum (procedure); Females

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0086287
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Beschreibung

Cardiovascular Diseases | Kidney Diseases | Liver diseases | Hematological Disease | Neoplasms | Endocrine System Diseases | Mental disorders| Rheumatism

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0205404
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0443343
UMLS CUI [3,3]
C0205404
UMLS CUI [4,1]
C0018939
UMLS CUI [4,2]
C0443343
UMLS CUI [4,3]
C0205404
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C0443343
UMLS CUI [5,3]
C0205404
UMLS CUI [6,1]
C0014130
UMLS CUI [6,2]
C0443343
UMLS CUI [6,3]
C0205404
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0443343
UMLS CUI [7,3]
C0205404
UMLS CUI [8,1]
C0035435
UMLS CUI [8,2]
C0443343
UMLS CUI [8,3]
C0205404
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00859898

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Therapy naive; Male Gender, Self Report | Age | Diabetes Mellitus, Non-Insulin-Dependent
Item
treatment naive males and females, >= 18 years old and <= 77 years old, with type 2 diabetes mellitus
boolean
C0919936 (UMLS CUI [1,1])
C1706180 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Hemoglobin A1c measurement; Central Laboratory; Randomization
Item
subjects must have central laboratory pre-randomization hemoglobin a1c >= 7.5 and <= 12.0%
boolean
C0474680 (UMLS CUI [1,1])
C1880016 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Insulin C-peptide measurement
Item
c-peptide >= 1.0 ng/ml (0.34 nmol/l)
boolean
C0202100 (UMLS CUI [1])
Body mass index
Item
body mass index <= 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Blood Glucose Self-Monitoring; Ability
Item
must be able to perform self monitoring of blood glucose
boolean
C0005803 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) >3x*upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
serum total bilirubin >2 mg/dl (34.2 µmol/l)
boolean
C1278039 (UMLS CUI [1])
Creatine kinase measurement
Item
creatinine kinase >3*uln
boolean
C0201973 (UMLS CUI [1])
Creatinine measurement, serum (procedure) | Male Gender, Self Report
Item
serum creatinine >= 1.50 mg/dl (133 µmol/l) for male subjects, >= 1.40 mg/dl (124
boolean
C0201976 (UMLS CUI [1])
C1706180 (UMLS CUI [2])
Creatinine measurement, serum (procedure); Females
Item
µmol/l) for female subjects
boolean
C0201976 (UMLS CUI [1])
C0086287 (UMLS CUI [2])
Cardiovascular Diseases | Kidney Diseases | Liver diseases | Hematological Disease | Neoplasms | Endocrine System Diseases | Mental disorders| Rheumatism
Item
currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0205404 (UMLS CUI [3,3])
C0018939 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0205404 (UMLS CUI [4,3])
C0027651 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0205404 (UMLS CUI [5,3])
C0014130 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0205404 (UMLS CUI [6,3])
C0004936 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0205404 (UMLS CUI [7,3])
C0035435 (UMLS CUI [8,1])
C0443343 (UMLS CUI [8,2])
C0205404 (UMLS CUI [8,3])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video