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Compliance of Diabetic Patients Treated With Metformin (CODAMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864705
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Martin Haluzik, Institute for Clinical and Experimental Medicine

Study Description
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Brief Summary:

Metformin is the 1st line treatment in all subjects with type 2 diabetes without a contraindication to its use. The compliance with the use of metformin is not optimal mainly owing to relatively frequent gastrointestinal side effects. However, hard data about the real compliance are currently not available.

In this trial we aim at assessing the compliance with metformin intake using a combination of serum metformin measurement and a specific questionnaire. We will further evaluate the impact of different pharmacological forms of metformin (standard vs. XR - extended release) on its compliance and try to identify common characteristics associated with reduced compliance.


Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Diagnostic Test: Measurement of plasma metformin levels

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compliance of Diabetic Patients Treated With Metformin
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Measurement of plasma metformin levels
    Subjects on chronic metformin therapy will have their plasma metformin levels measured during a regular check-up with glycated hemoglobin assessment.

Outcome Measures
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Primary Outcome Measures :
  1. Plasma metformin levels [ Time Frame: At the time of measurement ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with type 2 diabetes mellitus on metformin therapy for at least 3 months.
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus on metformin therapy for at least 3 months

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864705


Contacts
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Contact: Martin Haluzik, Prof. DSc. 261361111 martin.haluzik@ikem.cz

Locations
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Czechia
Institute for Clinical and Experimental Medicine Recruiting
Prague, Czechia, 14021
Contact: Martin Haluzik, Prof. DSc.    +420261361111    martin.haluzik@ikem.cz   
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Investigators
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Principal Investigator: Martin Haluzik, Prof. DSc. Institute for Clinical and Experimental Medicine
More Information
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Responsible Party: Martin Haluzik, Clinical Scientist, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT03864705    
Other Study ID Numbers: 001
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs