Real-world Clinical Effectiveness and Patient Insight Associated With Adding Sodium Glucose Co-transporter 2 Inhibitor to Gliclazide Modified Release (ADD2DIA)

Servier

Status: Completed

Conditions: Type 2 Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT06708091

DIM-05762-005

Details and patient eligibility

About

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.

Enrollment: 537 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

537 participants in 1 patient group

population description

Description:

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

Sponsor of this trial

Lead Sponsor

Servier