ID

38848

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01045707

Nyckelord

Versioner (1)
  1. 2019-11-09 2019-11-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 november 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Diabetes NCT01045707

Engelsk

Eligibility Diabetes NCT01045707

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01045707
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Clinical Trial Period Main

Datatyp

boolean

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
insulin naïve subjects
Beskrivning

Insulin Absent

Datatyp

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
Beskrivning

Metformin | Antidiabetics Oral Quantity

Datatyp

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)
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

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

Body mass index

Datatyp

boolean

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

Extension Period

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

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

Treatment completed Clinical Trial Specified

Datatyp

boolean

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

Exclusion Criteria

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

Clinical Trial Period Main

Datatyp

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
Beskrivning

GLP-1 Receptor Agonist | Thiazolidinediones

Datatyp

boolean

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

Cardiovascular Disease

Datatyp

boolean

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

Extension Period

Datatyp

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
Beskrivning

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

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding | Pregnancy intended | Contraceptive methods Absent

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Diabetes NCT01045707

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01045707
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial