Compliance of Diabetic Patients Treated With Metformin

Type 2 Diabetes Mellitus Clinical Trial

— CODAMET  

Official title:

Compliance of Diabetic Patients Treated With Metformin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03864705
• Other study ID #: 001
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2020
• Source: Institute for Clinical and Experimental Medicine
• Contact: Martin Haluzik, Prof. DSc.
• Phone: 261361111
• Email: martin.haluzik[@]ikem.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma metformin levels		At the time of measurement