ID

38875

Beschrijving

Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone; ODM derived from: https://clinicaltrials.gov/show/NCT01215435

Link

https://clinicaltrials.gov/show/NCT01215435

Trefwoorden

Versies (1)
  1. 11-11-19 11-11-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 november 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes NCT01215435

Engels

Eligibility Diabetes NCT01215435

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01215435
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes for a minimum of 6 months prior to visit 1
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c at least 7.0 % - maximum 11 % at screening
Beschrijving

Hemoglobin A1c measurement | Hemoglobin A1c measurement Maximum

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2,1]
C0474680
UMLS CUI [2,2]
C0806909
subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
Beschrijving

Insulin Absent | Insulin regime short-term allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0443303
UMLS CUI [2,3]
C0683607
an antidiabetic regimen that has been stable for at least 3 months prior to screening
Beschrijving

Diabetes Therapy Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274787
UMLS CUI [1,2]
C0205360
an antidiabetic regimen that includes a minimum of 2 oads
Beschrijving

Diabetes Therapy | Antidiabetics Oral Quantity Minimum

Datatype

boolean

Alias
UMLS CUI [1]
C3274787
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1524031
oads dosed at least 50% of the maximum recommended dose
Beschrijving

Antidiabetics Oral Dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected hypersensitivity to trial product(s) or related products
Beschrijving

Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
Beschrijving

Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
the receipt of any investigational medicinal product within one month prior to this trial
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
suffer from a life threatening disease (cancer)
Beschrijving

Life threatening illness | Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2]
C0006826
cardiac disease: class iii or iv congestive heart failure (chf), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
Beschrijving

Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction Treated | Myocardial Infarction Untreated

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0027051
UMLS CUI [5,2]
C0332155
hepatic insufficiency (alanine aminotransferase (alt) or aspartate aminotransferase (ast) above 2 times the central laboratory's upper reference limit)
Beschrijving

Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
Beschrijving

Renal Insufficiency | Creatinine measurement, serum | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
recurrent hypoglycaemia or hypoglycaemic unawareness
Beschrijving

Recurrent hypoglycemia | Loss of hypoglycemic warning

Datatype

boolean

Alias
UMLS CUI [1]
C1846288
UMLS CUI [2]
C0342317
anemia (haemoglobin below 10 mg/dl)
Beschrijving

Anemia | Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
Terug naar het begin van de pagina

Similar models

Eligibility Diabetes NCT01215435

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01215435
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosed with type 2 diabetes for a minimum of 6 months prior to visit 1
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement | Hemoglobin A1c measurement Maximum
Item
hba1c at least 7.0 % - maximum 11 % at screening
boolean
C0474680 (UMLS CUI [1])
C0474680 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Insulin Absent | Insulin regime short-term allowed
Item
subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0443303 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Diabetes Therapy Stable
Item
an antidiabetic regimen that has been stable for at least 3 months prior to screening
boolean
C3274787 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Diabetes Therapy | Antidiabetics Oral Quantity Minimum
Item
an antidiabetic regimen that includes a minimum of 2 oads
boolean
C3274787 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1524031 (UMLS CUI [2,4])
Antidiabetics Oral Dose
Item
oads dosed at least 50% of the maximum recommended dose
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected hypersensitivity to trial product(s) or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Pregnancy intended | Childbearing Potential Contraceptive methods Absent
Item
females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Investigational New Drugs
Item
the receipt of any investigational medicinal product within one month prior to this trial
boolean
C0013230 (UMLS CUI [1])
Life threatening illness | Malignant Neoplasms
Item
suffer from a life threatening disease (cancer)
boolean
C3846017 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Heart Disease | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction Treated | Myocardial Infarction Untreated
Item
cardiac disease: class iii or iv congestive heart failure (chf), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
boolean
C0018799 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0027051 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0027051 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
hepatic insufficiency (alanine aminotransferase (alt) or aspartate aminotransferase (ast) above 2 times the central laboratory's upper reference limit)
boolean
C1306571 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Recurrent hypoglycemia | Loss of hypoglycemic warning
Item
recurrent hypoglycaemia or hypoglycaemic unawareness
boolean
C1846288 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Anemia | Hemoglobin measurement
Item
anemia (haemoglobin below 10 mg/dl)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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