ID

29233

Beschreibung

Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00807092

Link

https://clinicaltrials.gov/show/NCT00807092

Stichworte

Versionen (1)
  1. 10.03.18 10.03.18 -
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See clinicaltrials.gov

Hochgeladen am

10. März 2018

DOI

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Eligibility Diabetes NCT00807092

Englisch

Eligibility Diabetes NCT00807092

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00807092
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes diagnosed 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-naive (less than or equal to 1 week of daily use of insulin therapy)
Beschreibung

Insulin naive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0919936
treatment with metformin as monotherapy or in combination therapy with other oad(s) for at least 3 months prior to this trial
Beschreibung

Metformin | Combined Modality Therapy | Antidiabetics Oral

Datentyp

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0009429
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
Beschreibung

Metformin U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0456683
currently at least one of other oad(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
Beschreibung

Antidiabetics Oral Quantity

Datentyp

boolean

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

Glucohemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
body mass index (bmi) between 18.5 - 35.0 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
be able and willing to perform continuous glucose monitoring system (cgms ) and self-monitored blood glucose (smbg)
Beschreibung

Glucose monitoring system Continuous | Blood Glucose Self-Monitoring

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3873850
UMLS CUI [1,2]
C0549178
UMLS CUI [2]
C0005803
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to trial product(s) or related products
Beschreibung

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

Datentyp

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
any contraindication of metformin
Beschreibung

Medical contraindication Metformin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
receipt of investigational drug within the last 3 months prior to this trial
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
any history of chronic insulin therapy (more than 1 week of daily use)
Beschreibung

Insulin regime chronic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205191
systemically treated with thiazolidinediones (tzds) for more than one month within 6 months prior to this trial
Beschreibung

Systemic therapy Thiazolidinediones

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1257987
pregnancy, nursing mother, or unwillingness to use adequate contraception
Beschreibung

Pregnancy | Breast Feeding | Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0558080
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Ähnliche Modelle

Eligibility Diabetes NCT00807092

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00807092
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes diagnosed for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin naive
Item
insulin-naive (less than or equal to 1 week of daily use of insulin therapy)
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Metformin | Combined Modality Therapy | Antidiabetics Oral
Item
treatment with metformin as monotherapy or in combination therapy with other oad(s) for at least 3 months prior to this trial
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
Metformin U/day
Item
currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
boolean
C0025598 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Antidiabetics Oral Quantity
Item
currently at least one of other oad(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Glucohemoglobin measurement
Item
glycosylated haemoglobin (hba1c) between 7.5-11.0%
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 18.5 - 35.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Glucose monitoring system Continuous | Blood Glucose Self-Monitoring
Item
be able and willing to perform continuous glucose monitoring system (cgms ) and self-monitored blood glucose (smbg)
boolean
C3873850 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2])
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 allergy 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])
Medical contraindication Metformin
Item
any contraindication of metformin
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
Investigational New Drugs
Item
receipt of investigational drug within the last 3 months prior to this trial
boolean
C0013230 (UMLS CUI [1])
Insulin regime chronic
Item
any history of chronic insulin therapy (more than 1 week of daily use)
boolean
C0557978 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Systemic therapy Thiazolidinediones
Item
systemically treated with thiazolidinediones (tzds) for more than one month within 6 months prior to this trial
boolean
C1515119 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Contraceptive methods Unwilling
Item
pregnancy, nursing mother, or unwillingness to use adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
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