ID

38868

Description

Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01123980

Link

https://clinicaltrials.gov/show/NCT01123980

Keywords

Versions (1)
  1. 11/11/19 11/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01123980

English

Eligibility Diabetes NCT01123980

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01123980
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes treated with a maximum of three different types of oral anti-diabetic drugs (oads) (including traditional chinese medicine which contains active ingredients of known oads) for more than 6 months
Description

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral Type Quantity | Traditional Chinese Medicine Relationship Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0332307
UMLS CUI [2,4]
C1265611
UMLS CUI [3,1]
C4331423
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0935929
UMLS CUI [3,4]
C1527415
unchanged total daily dose of at least 1500 mg (chinese patients) or 500 mg (japanese patients) metformin for the last two months
Description

Metformin Cumulative Dose U/day unchanged | Patients Chinese | Patients Japanese

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0456683
UMLS CUI [1,4]
C0442739
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0152035
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1556094
unchanged total daily dose of at least half maximum recommended total daily dose of any insulin secretagogue for the last two months
Description

Cumulative Dose Daily unchanged | Pills Releasing Insulin | Cumulative Dose Daily Maximum Half

Data type

boolean

Alias
UMLS CUI [1,1]
C2986497
UMLS CUI [1,2]
C0332173
UMLS CUI [1,3]
C0442739
UMLS CUI [2,1]
C0994475
UMLS CUI [2,2]
C1283071
UMLS CUI [2,3]
C0021641
UMLS CUI [3,1]
C2986497
UMLS CUI [3,2]
C0332173
UMLS CUI [3,3]
C0806909
UMLS CUI [3,4]
C2825407
insulin naive
Description

Insulin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
hba1c between 7.0% and 10.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
fpg (fasting plasma glucose) equal to or above 6.1 mmol/l (110mg/dl)
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
body mass index (bmi) below 40.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any thiazolidinedione (tzd) and glp-1 (glucagon like peptide-1) receptor antagonists during the last 3 months before visit 1 in this trial
Description

Thiazolidinediones | Glucagon-like Peptide-1 (GLP-1) Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C2916826
any disease or condition which the investigator feels would interfere with the trial
Description

Disease Interferes with Clinical Trial | Condition Interferes with Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
any contraindication to metformin or glimepiride (according to local labelling)
Description

Medical contraindication Metformin | Medical contraindication Glimepiride

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0025598
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0061323
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Similar models

Eligibility Diabetes NCT01123980

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01123980
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral Type Quantity | Traditional Chinese Medicine Relationship Antidiabetics Oral
Item
type 2 diabetes treated with a maximum of three different types of oral anti-diabetic drugs (oads) (including traditional chinese medicine which contains active ingredients of known oads) for more than 6 months
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0332307 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C4331423 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0935929 (UMLS CUI [3,3])
C1527415 (UMLS CUI [3,4])
Metformin Cumulative Dose U/day unchanged | Patients Chinese | Patients Japanese
Item
unchanged total daily dose of at least 1500 mg (chinese patients) or 500 mg (japanese patients) metformin for the last two months
boolean
C0025598 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0442739 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C0152035 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C1556094 (UMLS CUI [3,2])
Cumulative Dose Daily unchanged | Pills Releasing Insulin | Cumulative Dose Daily Maximum Half
Item
unchanged total daily dose of at least half maximum recommended total daily dose of any insulin secretagogue for the last two months
boolean
C2986497 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
C0994475 (UMLS CUI [2,1])
C1283071 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
C2986497 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
C0806909 (UMLS CUI [3,3])
C2825407 (UMLS CUI [3,4])
Insulin Absent
Item
insulin naive
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c between 7.0% and 10.0%
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fpg (fasting plasma glucose) equal to or above 6.1 mmol/l (110mg/dl)
boolean
C0583513 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below 40.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Thiazolidinediones | Glucagon-like Peptide-1 (GLP-1) Antagonists
Item
treatment with any thiazolidinedione (tzd) and glp-1 (glucagon like peptide-1) receptor antagonists during the last 3 months before visit 1 in this trial
boolean
C1257987 (UMLS CUI [1])
C2916826 (UMLS CUI [2])
Disease Interferes with Clinical Trial | Condition Interferes with Clinical Trial
Item
any disease or condition which the investigator feels would interfere with the trial
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Medical contraindication Metformin | Medical contraindication Glimepiride
Item
any contraindication to metformin or glimepiride (according to local labelling)
boolean
C1301624 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0061323 (UMLS CUI [2,2])
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