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

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT06708091
• Lead Sponsor: Servier Affaires Médicales

Brief Summary

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

Not available

Study Timeline

• Study Start: 2022-02-15
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 537

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
• Use of antidiabetic drugs other than those permitted by the inclusion criteria, at index date

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
effectiveness of adding SGLT2i to gliclazide MR	from index date (date of SGLT2i adding to gliclazide MR) to discontinuation of the combination (at least 2 months) or date of data collection initiation during the eligibility period, loss to follow-up, or death, whichever occurs first (approx 2 months)	To determine the effectiveness of adding SGLT2i to gliclazide MR-based therapy in patients with T2DM, as measured by HbA1c changes (in %)

Trial Locations

Locations (1)

Servier Affaires Médicales; 🇫🇷 Suresnes, France