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
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
Is the patient being treated with metformin tablets?
Description

Metformin treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0039225
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
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
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0443211
Is the patient over 18 years old?
Description

Age

Data type

boolean

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

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
UMLS CUI [1,2]
C0175795
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
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C1709515
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
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?
Description

Other confounding illnesses

Data type

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 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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