ID

29241

Description

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

Lien

https://clinicaltrials.gov/show/NCT00972283

Mots-clés

Versions (1)
  1. 11/03/2018 11/03/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

11 mars 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Diabetes NCT00972283

Anglais

Eligibility Diabetes NCT00972283

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00972283
Inclusion Criteria
Description

Inclusion Criteria

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

Period Main

Type de données

boolean

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Type de données

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
Description

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

Type de données

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)
Description

Glucohemoglobin measurement

Type de données

boolean

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

Body mass index

Type de données

boolean

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

Period Extension

Type de données

boolean

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

Therapeutic procedure Period Completion

Type de données

boolean

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

Exclusion Criteria

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

Period Main

Type de données

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
Description

Insulin regime | Exception Basal insulin | Exception Basal insulin Bolus

Type de données

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
Description

Cardiovascular Disease

Type de données

boolean

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

Severe Hypertension Uncontrolled Treated | Severe Hypertension Uncontrolled untreated

Type de données

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
Description

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

Type de données

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
Description

Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Diabetes NCT00972283

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00972283
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
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