ID

35817

Description

A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02505334

Link

https://clinicaltrials.gov/show/NCT02505334

Keywords

Versions (1)
  1. 3/25/19 3/25/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 25, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02505334

English

Eligibility Diabetes NCT02505334

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02505334
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female japanese subjects at least 20 years of age at the time of informed consent
Description

Japanese | Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0021430
type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c 7.5-10.0 % [58 mmol/mol-86 mmol/mol] (both inclusive)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
subjects on stable therapy with one oad (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved japanese labelling
Description

Antidiabetics Oral Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)
Description

Insulin regime Previous | Exception Therapy short-term Comorbidity | Exception Therapy short-term Gestational Diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0443303
UMLS CUI [2,4]
C0009488
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0443303
UMLS CUI [3,4]
C0085207
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
Description

Antidiabetics | Anti-Obesity Agents | Exception Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0376607
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1512693
screening calcitonin equal or above 50 ng/l
Description

Calcitonin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201924
history of pancreatitis (acute or chronic)
Description

Pancreatitis | Pancreatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 2)
Description

Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history Multiple Endocrine Neoplasia Type

Data type

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2]
C1833921
UMLS CUI [3,1]
C0027662
UMLS CUI [3,2]
C0332307
UMLS CUI [4,1]
C0241889
UMLS CUI [4,2]
C0027662
UMLS CUI [4,3]
C0332307
subjects presently classified as being in new york heart association (nyha) class iv
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
Description

Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0002965
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0007787
diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
Description

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Polyps | Exception Carcinoma in Situ

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0032584
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007099
any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
Description

Condition compromises Patient safety | Condition compromises Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
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Similar models

Eligibility Diabetes NCT02505334

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02505334
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Japanese | Age | Informed Consent
Item
male or female japanese subjects at least 20 years of age at the time of informed consent
boolean
C1556094 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c 7.5-10.0 % [58 mmol/mol-86 mmol/mol] (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Antidiabetics Oral Stable
Item
subjects on stable therapy with one oad (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved japanese labelling
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Insulin regime Previous | Exception Therapy short-term Comorbidity | Exception Therapy short-term Gestational Diabetes
Item
previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)
boolean
C0557978 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0443303 (UMLS CUI [3,3])
C0085207 (UMLS CUI [3,4])
Antidiabetics | Anti-Obesity Agents | Exception Inclusion criteria
Item
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
boolean
C0935929 (UMLS CUI [1])
C0376607 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
Calcitonin measurement
Item
screening calcitonin equal or above 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Medullary carcinoma of thyroid | Familial medullary thyroid carcinoma | Multiple Endocrine Neoplasia Type | Family history Multiple Endocrine Neoplasia Type
Item
personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia type 2 (men 2)
boolean
C0238462 (UMLS CUI [1])
C1833921 (UMLS CUI [2])
C0027662 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C0241889 (UMLS CUI [4,1])
C0027662 (UMLS CUI [4,2])
C0332307 (UMLS CUI [4,3])
New York Heart Association Classification
Item
subjects presently classified as being in new york heart association (nyha) class iv
boolean
C1275491 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack
Item
within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0002965 (UMLS CUI [3,2])
C0019993 (UMLS CUI [4,1])
C0007787 (UMLS CUI [4,2])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Polyps | Exception Carcinoma in Situ
Item
diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0032584 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
Condition compromises Patient safety | Condition compromises Protocol Compliance
Item
any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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