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Real-world Clinical Effectiveness and Patient Insight Associated With Adding Sodium Glucose Co-transporter 2 Inhibitor to Gliclazide Modified Release

NCT ID: NCT06708091

Last Updated: 2024-11-27

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

COMPLETED

Total Enrollment

537 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-15

Study Completion Date

2024-05-31

Brief Summary

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The study objectives are to assess over the gliclazide MR-SGLT2i combined treatment course in patients with T2DM adding SGLT2i to gliclazide MR-based therapy.

The primary objective is to determine the effectiveness of adding SGLT2i to gliclazide MR-based therapy in patients with T2DM, as measured by HbA1c changes.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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population description

adult patients with T2DM who initiated add-on SGLT2i treatment to gliclazide MR 60 mg, in routine practice

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient diagnosed with T2DM for at least two years prior to index date
* Patient aged ≥18 years at the index date
* Patient naïve to SGLT2i prior to index date
* Patient treated with gliclazide MR at a minimum daily dose of 60 mg at the index date
* Starting treatment with SGLT2i added to gliclazide MR based therapy, during the eligibility period, with a minimum of 60 days of combined gliclazide MR-SGLT2i treatment
* Presence of at least two assessments of HbA1c laboratory test results from the medical records

Exclusion Criteria

* Diagnosis of diabetes other than T2DM (e.g., type 1, gestational) at index date
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Servier Affaires Médicales

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Servier Affaires Médicales

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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DIM-05762-005

Identifier Type: -

Identifier Source: org_study_id