ID

44057

Description

Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01650129

Link

https://clinicaltrials.gov/show/NCT01650129

Keywords

Versions (3)
  1. 3/31/16 3/31/16 -
  2. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01650129

English

Eligibility Diabetes NCT01650129

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01650129
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 diabetes
Description

Type 2 diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011860
subjects with insulin treated for at least 24 weeks
Description

Duration of insulin treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0444921
UMLS CUI [1,2]
C0745343
hba1c maximum 11.0%
Description

Hba1c

Data type

boolean

Alias
UMLS CUI [1]
C0019018
body mass index (bmi) below 30.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (smbg) and are able to take measures against hypoglycaemic episodes
Description

Self-injection of insulin and self-monitoring blood glucose

Data type

boolean

Alias
UMLS CUI [1,1]
C3880392
UMLS CUI [1,2]
C0745343
UMLS CUI [2]
C0005803
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
recurrent severe hypoglycaemia
Description

Recurrent severe hypoglycaemia

Data type

boolean

Alias
UMLS CUI [1]
C0342316
subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
Description

Ophthalmological status

Data type

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2,1]
C0339473
UMLS CUI [2,2]
C2316983
UMLS CUI [3,1]
C0023694
UMLS CUI [3,2]
C2584899
impaired hepatic function
Description

Hepatic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
impaired renal function
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
cardiac diseases
Description

Cardiac diseases

Data type

boolean

Alias
UMLS CUI [1]
C0018799
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
subjects with history of severe allergic or severe hypersensitive reactions
Description

Allergies and Hypersensitivity reactions

Data type

boolean

Alias
UMLS CUI [1]
C0020517
total daily insulin dose at least 100 iu
Description

Daily insulin dose

Data type

boolean

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0557978
treatment with oral hypoglycaemic agents within the last 4 weeks
Description

Oral hypoglycaemic agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C3173309
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Similar models

Eligibility Diabetes NCT01650129

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01650129
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Type 2 diabetes
Item
subjects with type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Duration of insulin treatment
Item
subjects with insulin treated for at least 24 weeks
boolean
C0444921 (UMLS CUI [1,1])
C0745343 (UMLS CUI [1,2])
Hba1c
Item
hba1c maximum 11.0%
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below 30.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Self-injection of insulin and self-monitoring blood glucose
Item
patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (smbg) and are able to take measures against hypoglycaemic episodes
boolean
C3880392 (UMLS CUI [1,1])
C0745343 (UMLS CUI [1,2])
C0005803 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Recurrent severe hypoglycaemia
Item
recurrent severe hypoglycaemia
boolean
C0342316 (UMLS CUI [1])
Ophthalmological status
Item
subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
boolean
C0339467 (UMLS CUI [1])
C0339473 (UMLS CUI [2,1])
C2316983 (UMLS CUI [2,2])
C0023694 (UMLS CUI [3,1])
C2584899 (UMLS CUI [3,2])
Hepatic function
Item
impaired hepatic function
boolean
C0232741 (UMLS CUI [1])
Renal function
Item
impaired renal function
boolean
C0232804 (UMLS CUI [1])
Cardiac diseases
Item
cardiac diseases
boolean
C0018799 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Allergies and Hypersensitivity reactions
Item
subjects with history of severe allergic or severe hypersensitive reactions
boolean
C0020517 (UMLS CUI [1])
Daily insulin dose
Item
total daily insulin dose at least 100 iu
boolean
C2348070 (UMLS CUI [1,1])
C0557978 (UMLS CUI [1,2])
Oral hypoglycaemic agents
Item
treatment with oral hypoglycaemic agents within the last 4 weeks
boolean
C0359086 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
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