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ID

36435

Description

Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets; ODM derived from: https://clinicaltrials.gov/show/NCT01510522 Brief Summary: This is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients treated with Glucophage tablets.

Link

https://clinicaltrials.gov/show/NCT01510522

Keywords

Versions (2)
  1. 1/16/19 1/16/19 -
  2. 5/14/19 5/14/19 -
Copyright Holder

Merck KGaA, Darmstadt, Germany

Uploaded on

May 14, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Adherence to Glucophage Sachets vs Tablets in Type 2 Diabetes NCT01510522

    English

    Eligibility Criteria

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

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    Is type 2 diabetes diagnosed?
    Description

    Diabetes mellitus type 2 should be diagnosed: baseline glycemia > 7,0 mmol/l (126 mg/dl) or overload glycemia > 11,0 mmol/l (198 mg/dl) as criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011860 (Diabetes Mellitus, Non-Insulin-Dependent)
    SNOMED
    44054006
    Is the patient being treated with metformin tablets?
    Description

    Metformin treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0025598 (metformin)
    SNOMED
    109081006
    UMLS CUI [1,2]
    C0039225 (Tablet Dosage Form)
    SNOMED
    385055001
    LOINC
    LP136501-6
    Does the patient have at least 2 comorbidities?
    Description

    Patients shoudl have at least 2 treated co-morbidities

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    Does the patient have an established dose of metformin > 1.700 mg/day?
    Description

    Patients should have an established dose of metformin > 1.700 mg/day

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0025598 (metformin)
    SNOMED
    109081006
    UMLS CUI [1,2]
    C2348070 (Daily Dose)
    UMLS CUI [1,3]
    C0443211 (Established)
    SNOMED
    263748003
    Is the patient over 18 years old?
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Is informed consent given?
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    Is the patient able to take medication orally?
    Description

    Patients not able to take medication orally should be excluded

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2712086 (Able to swallow)
    SNOMED
    288936000
    UMLS CUI [1,2]
    C0175795 (Oral Medication)
    Are there exclusions given according to summary of product characteristics (smpc)?
    Description

    Are there exclusions given according to summary of product characteristics (smpc)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251 (Exclusion Criteria)
    UMLS CUI [1,2]
    C0332290 (Consistent with)
    SNOMED
    385433004
    UMLS CUI [1,3]
    C1709515 (Pharmaceutical Product Characteristics)
    Does the patient participate in another clinical trial 30 days prior to randomization?
    Description

    Different clinical trial

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [1,2]
    C0332185 (Recent)
    SNOMED
    6493001
    Are the any other illness or medical or psychiatric conditions, severe and uncontrolled that could interfere in the patient's participation or in the assessment of the study results?
    Description

    Other confounding illnesses

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423 (Illness (finding))
    SNOMED
    39104002
    UMLS CUI [1,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [1,3]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [1,4]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [1,5]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [2,1]
    C0221423 (Illness (finding))
    SNOMED
    39104002
    UMLS CUI [2,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [2,3]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [2,4]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [2,5]
    C0683954 (research results)
    UMLS CUI [3,1]
    C0205476 (Medical)
    SNOMED
    74188005
    UMLS CUI [3,2]
    C0348080 (Condition)
    SNOMED
    260905004
    LOINC
    LP185404-3
    UMLS CUI [3,3]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [3,4]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [3,5]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [3,6]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [4,1]
    C0205476 (Medical)
    SNOMED
    74188005
    UMLS CUI [4,2]
    C0348080 (Condition)
    SNOMED
    260905004
    LOINC
    LP185404-3
    UMLS CUI [4,3]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [4,4]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [4,5]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [4,6]
    C0683954 (research results)
    UMLS CUI [5,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [5,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [5,3]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [5,4]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [5,5]
    C2348568 (Study Subject Participation Status)
    UMLS CUI [6,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [6,2]
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    UMLS CUI [6,3]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [6,4]
    C0521102 (Interferes with)
    SNOMED
    78235001
    UMLS CUI [6,5]
    C0683954 (research results)
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    Similar models

    Eligibility Criteria

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Diagnosed type 2 diabetes
    Item
    Is type 2 diabetes diagnosed?
    boolean
    C0011860 (UMLS CUI [1])
    Metformin treatment
    Item
    Is the patient being treated with metformin tablets?
    boolean
    C0025598 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Comorbidities
    Item
    Does the patient have at least 2 comorbidities?
    boolean
    C0009488 (UMLS CUI [1])
    Daily Metformin dose
    Item
    Does the patient have an established dose of metformin > 1.700 mg/day?
    boolean
    C0025598 (UMLS CUI [1,1])
    C2348070 (UMLS CUI [1,2])
    C0443211 (UMLS CUI [1,3])
    Age
    Item
    Is the patient over 18 years old?
    boolean
    C0001779 (UMLS CUI [1])
    Informed consent
    Item
    Is informed consent given?
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Ability to take medication p.o.
    Item
    Is the patient able to take medication orally?
    boolean
    C2712086 (UMLS CUI [1,1])
    C0175795 (UMLS CUI [1,2])
    Exclusion by SMPC
    Item
    Are there exclusions given according to summary of product characteristics (smpc)?
    boolean
    C0680251 (UMLS CUI [1,1])
    C0332290 (UMLS CUI [1,2])
    C1709515 (UMLS CUI [1,3])
    Different clinical trial
    Item
    Does the patient participate in another clinical trial 30 days prior to randomization?
    boolean
    C2348568 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    Other confounding illnesses
    Item
    Are the any other illness or medical or psychiatric conditions, severe and uncontrolled that could interfere in the patient's participation or in the assessment of the study results?
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0205318 (UMLS CUI [1,3])
    C0521102 (UMLS CUI [1,4])
    C2348568 (UMLS CUI [1,5])
    C0221423 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C0205318 (UMLS CUI [2,3])
    C0521102 (UMLS CUI [2,4])
    C0683954 (UMLS CUI [2,5])
    C0205476 (UMLS CUI [3,1])
    C0348080 (UMLS CUI [3,2])
    C0205082 (UMLS CUI [3,3])
    C0205318 (UMLS CUI [3,4])
    C0521102 (UMLS CUI [3,5])
    C2348568 (UMLS CUI [3,6])
    C0205476 (UMLS CUI [4,1])
    C0348080 (UMLS CUI [4,2])
    C0205082 (UMLS CUI [4,3])
    C0205318 (UMLS CUI [4,4])
    C0521102 (UMLS CUI [4,5])
    C0683954 (UMLS CUI [4,6])
    C0004936 (UMLS CUI [5,1])
    C0205082 (UMLS CUI [5,2])
    C0205318 (UMLS CUI [5,3])
    C0521102 (UMLS CUI [5,4])
    C2348568 (UMLS CUI [5,5])
    C0004936 (UMLS CUI [6,1])
    C0205082 (UMLS CUI [6,2])
    C0205318 (UMLS CUI [6,3])
    C0521102 (UMLS CUI [6,4])
    C0683954 (UMLS CUI [6,5])
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