ID

38920

Description

Liraglutide or Insulin in Real Life Usage in Patients With Diabetes Mellitus Type 2; ODM derived from: https://clinicaltrials.gov/show/NCT01484262

Link

https://clinicaltrials.gov/show/NCT01484262

Keywords

Versions (1)
  1. 11/12/19 11/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01484262

English

Eligibility Diabetes NCT01484262

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01484262
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any study-related activities. (study-related activities are any procedures related to recording of data according to the protocol)
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients willing and able to give signed consent on matching patient data with sick fund data
Description

Consent Patient data Matching | Sick Fund Data

Data type

boolean

Alias
UMLS CUI [1,1]
C1511481
UMLS CUI [1,2]
C2707520
UMLS CUI [1,3]
C1708943
UMLS CUI [2,1]
C1411275
UMLS CUI [2,2]
C0016820
UMLS CUI [2,3]
C1511726
patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (victoza®) due to inadequate blood glucose control
Description

Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Patient need for Intensification therapy | Insulin | liraglutide | Victoza | Etiology Blood Glucose Poorly controlled

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C1511484
UMLS CUI [4]
C0021641
UMLS CUI [5]
C1456408
UMLS CUI [6]
C2732208
UMLS CUI [7,1]
C0015127
UMLS CUI [7,2]
C0005802
UMLS CUI [7,3]
C3853134
patient is a member of the involved sick fund (aok plus)
Description

Membership Sick Fund

Data type

boolean

Alias
UMLS CUI [1,1]
C0680038
UMLS CUI [1,2]
C1411275
UMLS CUI [1,3]
C0016820
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected contra-indication to the relevant study product according to current spc
Description

Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0013230
previous participation in this study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
history of type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days)
Description

Insulin regime Previous | Exception Emergency treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013969
previous treatment with liraglutide
Description

Prior Therapy Liraglutide

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1456408
history of diabetic gastroparesis, diabetic precoma or diabetic ketoacidosis
Description

Gastroparesis due to diabetes mellitus | Precoma Diabetic | Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0267176
UMLS CUI [2,1]
C1142529
UMLS CUI [2,2]
C0241863
UMLS CUI [3]
C0011880
progressive fatal disease
Description

Progressive Disease Fatal

Data type

boolean

Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C1302234
any reason in judgement of the treating physician that precludes study participation e.g. lack of compliance, safety concerns, alcohol or drug abuse
Description

Study Subject Participation Status Excluded | Compliance behavior Lacking | Patient safety Concern | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0332196
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C1113679
UMLS CUI [3,2]
C2699424
UMLS CUI [4]
C0038586
patients without legal capacity
Description

Legal capacity Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
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Similar models

Eligibility Diabetes NCT01484262

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01484262
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any study-related activities. (study-related activities are any procedures related to recording of data according to the protocol)
boolean
C0021430 (UMLS CUI [1])
Consent Patient data Matching | Sick Fund Data
Item
patients willing and able to give signed consent on matching patient data with sick fund data
boolean
C1511481 (UMLS CUI [1,1])
C2707520 (UMLS CUI [1,2])
C1708943 (UMLS CUI [1,3])
C1411275 (UMLS CUI [2,1])
C0016820 (UMLS CUI [2,2])
C1511726 (UMLS CUI [2,3])
Diabetes Mellitus, Non-Insulin-Dependent | Antidiabetics Oral | Patient need for Intensification therapy | Insulin | liraglutide | Victoza | Etiology Blood Glucose Poorly controlled
Item
patients diagnosed with type 2 diabetes mellitus, currently treated with oral antidiabetic medication, who need treatment intensification with insulin or liraglutide (victoza®) due to inadequate blood glucose control
boolean
C0011860 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C1511484 (UMLS CUI [3,2])
C0021641 (UMLS CUI [4])
C1456408 (UMLS CUI [5])
C2732208 (UMLS CUI [6])
C0015127 (UMLS CUI [7,1])
C0005802 (UMLS CUI [7,2])
C3853134 (UMLS CUI [7,3])
Membership Sick Fund
Item
patient is a member of the involved sick fund (aok plus)
boolean
C0680038 (UMLS CUI [1,1])
C1411275 (UMLS CUI [1,2])
C0016820 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Investigational New Drugs | Medical contraindication Suspected Investigational New Drugs
Item
known or suspected contra-indication to the relevant study product according to current spc
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
Study Subject Participation Status
Item
previous participation in this study
boolean
C2348568 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent
Item
history of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Insulin regime Previous | Exception Emergency treatment
Item
previous insulin treatment excluding emergency administration (treatment duration up to a maximum of 3 days)
boolean
C0557978 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013969 (UMLS CUI [2,2])
Prior Therapy Liraglutide
Item
previous treatment with liraglutide
boolean
C1514463 (UMLS CUI [1,1])
C1456408 (UMLS CUI [1,2])
Gastroparesis due to diabetes mellitus | Precoma Diabetic | Diabetic Ketoacidosis
Item
history of diabetic gastroparesis, diabetic precoma or diabetic ketoacidosis
boolean
C0267176 (UMLS CUI [1])
C1142529 (UMLS CUI [2,1])
C0241863 (UMLS CUI [2,2])
C0011880 (UMLS CUI [3])
Progressive Disease Fatal
Item
progressive fatal disease
boolean
C1335499 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
Study Subject Participation Status Excluded | Compliance behavior Lacking | Patient safety Concern | Substance Use Disorders
Item
any reason in judgement of the treating physician that precludes study participation e.g. lack of compliance, safety concerns, alcohol or drug abuse
boolean
C2348568 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C1113679 (UMLS CUI [3,1])
C2699424 (UMLS CUI [3,2])
C0038586 (UMLS CUI [4])
Legal capacity Lacking
Item
patients without legal capacity
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
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