Compliance of Diabetic Patients Treated With Metformin

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT03864705
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-03
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-11
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma metformin levels	At the time of measurement

Trial Locations

Locations (1)

Institute for Clinical and Experimental Medicine; 🇨🇿 Prague, Czechia