ID

38926

Description

Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01572740

Link

https://clinicaltrials.gov/show/NCT01572740

Keywords

Versions (1)
  1. 11/13/19 11/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01572740

English

Eligibility Diabetes NCT01572740

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01572740
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (i)u/day
Description

Insulin regime | Basal insulin | Premixed insulin | Basal insulin Bolus | Diet therapy | Exercise | Insulin Cumulative Dose U/day

Data type

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2]
C0650607
UMLS CUI [3]
C2069057
UMLS CUI [4,1]
C0650607
UMLS CUI [4,2]
C1705509
UMLS CUI [5]
C0012159
UMLS CUI [6]
C0015259
UMLS CUI [7,1]
C0021641
UMLS CUI [7,2]
C2986497
UMLS CUI [7,3]
C0456683
glycosylated haemoglobin (hba1c) between 7.5 and 11.0% (both inclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) below 45.0 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (mao) inhibitors
Description

Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0580105
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0596620
UMLS CUI [2]
C3653708
UMLS CUI [3]
C0304516
UMLS CUI [4]
C0026457
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Description

Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2,1]
C0745153
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0342317
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0011880
known proliferative retinopathy or maculopathy requiring treatment according to the investigator
Description

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
treatment with glucagon-like peptide-1 (glp-1) receptor agonist within 12 weeks prior to screening
Description

GLP-1 Receptor Agonist

Data type

boolean

Alias
UMLS CUI [1]
C2917359
treatment with any oral antidiabetic drugs (oads) within 12 weeks prior to screening
Description

Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
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Similar models

Eligibility Diabetes NCT01572740

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01572740
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Insulin regime | Basal insulin | Premixed insulin | Basal insulin Bolus | Diet therapy | Exercise | Insulin Cumulative Dose U/day
Item
current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (i)u/day
boolean
C0557978 (UMLS CUI [1])
C0650607 (UMLS CUI [2])
C2069057 (UMLS CUI [3])
C0650607 (UMLS CUI [4,1])
C1705509 (UMLS CUI [4,2])
C0012159 (UMLS CUI [5])
C0015259 (UMLS CUI [6])
C0021641 (UMLS CUI [7,1])
C2986497 (UMLS CUI [7,2])
C0456683 (UMLS CUI [7,3])
Hemoglobin A1c measurement
Item
glycosylated haemoglobin (hba1c) between 7.5 and 11.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) below 45.0 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Change of medication Interferes with Glucose metabolism | CORTICOSTEROIDS FOR SYSTEMIC USE | Adrenergic beta-1 Receptor Antagonists | Monoamine Oxidase Inhibitors
Item
anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (mao) inhibitors
boolean
C0580105 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C3653708 (UMLS CUI [2])
C0304516 (UMLS CUI [3])
C0026457 (UMLS CUI [4])
Recurrent severe hypoglycemia | Hypoglycaemic episode Severe Quantity | Loss of hypoglycemic warning | Hospitalization Diabetic Ketoacidosis
Item
recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
boolean
C0342316 (UMLS CUI [1])
C0745153 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0342317 (UMLS CUI [3])
C0019993 (UMLS CUI [4,1])
C0011880 (UMLS CUI [4,2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for
Item
known proliferative retinopathy or maculopathy requiring treatment according to the investigator
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
GLP-1 Receptor Agonist
Item
treatment with glucagon-like peptide-1 (glp-1) receptor agonist within 12 weeks prior to screening
boolean
C2917359 (UMLS CUI [1])
Antidiabetics Oral
Item
treatment with any oral antidiabetic drugs (oads) within 12 weeks prior to screening
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
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