ID

29241

Beschreibung

Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00972283

Link

https://clinicaltrials.gov/show/NCT00972283

Stichworte

Versionen (1)
  1. 11.03.18 11.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. März 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 Diabetes NCT00972283

Englisch

Eligibility Diabetes NCT00972283

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00972283
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
for main period (nn1250-3582):
Beschreibung

Period Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C1542147
type 2 diabetes mellitus for at least 6 months
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (oad) prior to trial start
Beschreibung

Insulin regime | Other Coding | Other Coding | Basal insulin | Basal insulin Bolus | Antidiabetics Oral

Datentyp

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2]
C3846158
UMLS CUI [3]
C3846158
UMLS CUI [4]
C0650607
UMLS CUI [5,1]
C0650607
UMLS CUI [5,2]
C1705509
UMLS CUI [6,1]
C0935929
UMLS CUI [6,2]
C1527415
hba1c 7.0-10.0 % (both inclusive)
Beschreibung

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
body mass index (bmi) below or equal to 40.0 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
for extension period (nn1250-3667):
Beschreibung

Period Extension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C0231448
completion of the 52 week treatment period in nn1250-3582
Beschreibung

Therapeutic procedure Period Completion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2347804
UMLS CUI [1,3]
C0205197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
for main period (nn1250-3582):
Beschreibung

Period Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C1542147
treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
Beschreibung

Insulin regime | Exception Basal insulin | Exception Basal insulin Bolus

Datentyp

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0650607
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0650607
UMLS CUI [3,3]
C1705509
cardiovascular disease within the last 6 months
Beschreibung

Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
uncontrolled treated/untreated severe hypertension
Beschreibung

Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4013784
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C4013784
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0332155
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
cancer and medical history of cancer
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Diabetes NCT00972283

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00972283
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Period Main
Item
for main period (nn1250-3582):
boolean
C2347804 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin regime | Other Coding | Other Coding | Basal insulin | Basal insulin Bolus | Antidiabetics Oral
Item
ongoing daily treatment with insulin (premix, self-mix, basal only, basal bolus) for at least 3 months with/without oral anti-diabetics drug (oad) prior to trial start
boolean
C0557978 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
C0650607 (UMLS CUI [4])
C0650607 (UMLS CUI [5,1])
C1705509 (UMLS CUI [5,2])
C0935929 (UMLS CUI [6,1])
C1527415 (UMLS CUI [6,2])
Glucohemoglobin measurement
Item
hba1c 7.0-10.0 % (both inclusive)
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below or equal to 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Period Extension
Item
for extension period (nn1250-3667):
boolean
C2347804 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Therapeutic procedure Period Completion
Item
completion of the 52 week treatment period in nn1250-3582
boolean
C0087111 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Period Main
Item
for main period (nn1250-3582):
boolean
C2347804 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Insulin regime | Exception Basal insulin | Exception Basal insulin Bolus
Item
treatment with other insulin regimens than premix, self-mix, basal only, basal bolus within 3 months
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0650607 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0650607 (UMLS CUI [3,2])
C1705509 (UMLS CUI [3,3])
Cardiovascular Disease
Item
cardiovascular disease within the last 6 months
boolean
C0007222 (UMLS CUI [1])
Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated
Item
uncontrolled treated/untreated severe hypertension
boolean
C4013784 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C4013784 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Malignant Neoplasms
Item
cancer and medical history of cancer
boolean
C0006826 (UMLS CUI [1])
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