Compliance of Diabetic Patients Treated With Metformin

NCT ID: NCT03864705

Last Updated: 2020-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Martin Haluzik

Clinical Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Haluzik, Prof. DSc.

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical and Experimental Medicine

Locations

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Institute for Clinical and Experimental Medicine

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Martin Haluzik, Prof. DSc.

Role: CONTACT

261361111

Facility Contacts

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Martin Haluzik, Prof. DSc.

Role: primary

+420261361111

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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