ID

38848

Beschreibung

Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01045707

Link

https://clinicaltrials.gov/show/NCT01045707

Stichworte

Versionen (1)
  1. 09.11.19 09.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. November 2019

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 NCT01045707

Englisch

Eligibility Diabetes NCT01045707

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01045707
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
for main period (nn5401-3590):
Beschreibung

Clinical Trial Period Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C1542147
diagnosis of 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
insulin naïve subjects
Beschreibung

Insulin Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
Beschreibung

Metformin | Antidiabetics Oral Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
glycosylated haemoglobin (hba1c) between 7.5 - 11.0% (both inclusive)
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) no higher than 40.0 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
for extension period (nn5401-3726):
Beschreibung

Extension Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C0231448
informed consent obtained before any trial-related activities
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
must have completed the 26-week treatment period (visit 28) in trial nn5401-3590
Beschreibung

Treatment completed Clinical Trial Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0580352
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
for main period (nn5401-3590):
Beschreibung

Clinical Trial Period Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C1542147
treatment with glucagon like peptide-1 (glp-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
Beschreibung

GLP-1 Receptor Agonist | Thiazolidinediones

Datentyp

boolean

Alias
UMLS CUI [1]
C2917359
UMLS CUI [2]
C1257987
cardiovascular disease diagnosed within 6 months before trial start
Beschreibung

Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
for extension period (nn5401-3726):
Beschreibung

Extension Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347804
UMLS CUI [1,2]
C0231448
anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (mao) inhibitors
Beschreibung

Change of medication Anticipated | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C3840775
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0596620
UMLS CUI [3]
C3653708
UMLS CUI [4]
C0304516
UMLS CUI [5]
C0026457
anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
Beschreibung

Lifestyle changes Anticipated | Shift work | Night shift worker Permanent | Evening shift worker Permanent | Eating habits Variation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0870811
UMLS CUI [1,2]
C3840775
UMLS CUI [2]
C1658633
UMLS CUI [3,1]
C0555008
UMLS CUI [3,2]
C0205355
UMLS CUI [4,1]
C4316563
UMLS CUI [4,2]
C0205355
UMLS CUI [5,1]
C1266864
UMLS CUI [5,2]
C0205419
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Beschreibung

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Diabetes NCT01045707

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01045707
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Period Main
Item
for main period (nn5401-3590):
boolean
C2347804 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosis of type 2 diabetes mellitus for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin Absent
Item
insulin naïve subjects
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Metformin | Antidiabetics Oral Quantity
Item
treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
boolean
C0025598 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) between 7.5 - 11.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) no higher than 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Extension Period
Item
for extension period (nn5401-3726):
boolean
C2347804 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Informed Consent
Item
informed consent obtained before any trial-related activities
boolean
C0021430 (UMLS CUI [1])
Treatment completed Clinical Trial Specified
Item
must have completed the 26-week treatment period (visit 28) in trial nn5401-3590
boolean
C0580352 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Clinical Trial Period Main
Item
for main period (nn5401-3590):
boolean
C2347804 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
GLP-1 Receptor Agonist | Thiazolidinediones
Item
treatment with glucagon like peptide-1 (glp-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
boolean
C2917359 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
Cardiovascular Disease
Item
cardiovascular disease diagnosed within 6 months before trial start
boolean
C0007222 (UMLS CUI [1])
Extension Period
Item
for extension period (nn5401-3726):
boolean
C2347804 (UMLS CUI [1,1])
C0231448 (UMLS CUI [1,2])
Change of medication Anticipated | Pharmaceutical Preparations Interfere with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors
Item
anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (mao) inhibitors
boolean
C0580105 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C3653708 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C0026457 (UMLS CUI [5])
Lifestyle changes Anticipated | Shift work | Night shift worker Permanent | Evening shift worker Permanent | Eating habits Variation
Item
anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
boolean
C0870811 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C1658633 (UMLS CUI [2])
C0555008 (UMLS CUI [3,1])
C0205355 (UMLS CUI [3,2])
C4316563 (UMLS CUI [4,1])
C0205355 (UMLS CUI [4,2])
C1266864 (UMLS CUI [5,1])
C0205419 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent
Item
pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
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