0 Beoordelingen
ID

36435

Beschrijving

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

Trefwoorden

Versies (2)
  1. 16-01-19 16-01-19 -
  2. 14-05-19 14-05-19 -
Houder van rechten

Merck KGaA, Darmstadt, Germany

Geüploaded op

14 mei 2019

DOI

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Licentie

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

    Engels

    Eligibility Criteria

    1 Formulieren  
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    Is type 2 diabetes diagnosed?
    Beschrijving

    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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0011860
    Is the patient being treated with metformin tablets?
    Beschrijving

    Metformin treatment

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0025598
    UMLS CUI [1,2]
    C0039225
    Does the patient have at least 2 comorbidities?
    Beschrijving

    Patients shoudl have at least 2 treated co-morbidities

    Datatype

    boolean

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

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0025598
    UMLS CUI [1,2]
    C2348070
    UMLS CUI [1,3]
    C0443211
    Is the patient over 18 years old?
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Is informed consent given?
    Beschrijving

    Informed consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    Is the patient able to take medication orally?
    Beschrijving

    Patients not able to take medication orally should be excluded

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2712086
    UMLS CUI [1,2]
    C0175795
    Are there exclusions given according to summary of product characteristics (smpc)?
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C0332290
    UMLS CUI [1,3]
    C1709515
    Does the patient participate in another clinical trial 30 days prior to randomization?
    Beschrijving

    Different clinical trial

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C0332185
    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?
    Beschrijving

    Other confounding illnesses

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0205318
    UMLS CUI [1,4]
    C0521102
    UMLS CUI [1,5]
    C2348568
    UMLS CUI [2,1]
    C0221423
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [2,3]
    C0205318
    UMLS CUI [2,4]
    C0521102
    UMLS CUI [2,5]
    C0683954
    UMLS CUI [3,1]
    C0205476
    UMLS CUI [3,2]
    C0348080
    UMLS CUI [3,3]
    C0205082
    UMLS CUI [3,4]
    C0205318
    UMLS CUI [3,5]
    C0521102
    UMLS CUI [3,6]
    C2348568
    UMLS CUI [4,1]
    C0205476
    UMLS CUI [4,2]
    C0348080
    UMLS CUI [4,3]
    C0205082
    UMLS CUI [4,4]
    C0205318
    UMLS CUI [4,5]
    C0521102
    UMLS CUI [4,6]
    C0683954
    UMLS CUI [5,1]
    C0004936
    UMLS CUI [5,2]
    C0205082
    UMLS CUI [5,3]
    C0205318
    UMLS CUI [5,4]
    C0521102
    UMLS CUI [5,5]
    C2348568
    UMLS CUI [6,1]
    C0004936
    UMLS CUI [6,2]
    C0205082
    UMLS CUI [6,3]
    C0205318
    UMLS CUI [6,4]
    C0521102
    UMLS CUI [6,5]
    C0683954
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    Similar models

    Eligibility Criteria

    1 Formulieren
    1. StudyEvent: Eligibility
      1. Eligibility Criteria
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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