Compliance of Diabetic Patients Treated With Metformin

Compliance of Diabetic Patients Treated With Metformin

Sponsors

Lead Sponsor: Institute for Clinical and Experimental Medicine

Source Institute for Clinical and Experimental Medicine
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.

Overall Status Recruiting
Start Date March 1, 2019
Completion Date December 31, 2021
Primary Completion Date December 31, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Plasma metformin levels At the time of measurement
Enrollment 400
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Measurement of plasma metformin levels

Description: Subjects on chronic metformin therapy will have their plasma metformin levels measured during a regular check-up with glycated hemoglobin assessment.

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

-

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Martin Haluzik, Prof. DSc. Principal Investigator Institute for Clinical and Experimental Medicine
Overall Contact

Last Name: Martin Haluzik, Prof. DSc.

Phone: 261361111

Email: [email protected]

Location
Facility: Status: Contact: Institute for Clinical and Experimental Medicine Martin Haluzik, Prof. DSc. +420261361111 [email protected]
Location Countries

Czechia

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Institute for Clinical and Experimental Medicine

Investigator Full Name: Martin Haluzik

Investigator Title: Clinical Scientist

Has Expanded Access No
Condition Browse
Acronym CODAMET
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov