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

NCT06708091 | Completed

• 1 other identifier: DIM-05762-005
• Study Type: observational
• Target: 537
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

observational; HbA1c; type 2 diabetes; gliclazide MR; SGLT2i; gliclazide MR combined to SGLT2i; retrospective; chart review

Outcome Measures

Primary Outcomes (1)

• effectiveness of adding SGLT2i to gliclazide MR

  To determine the effectiveness of adding SGLT2i to gliclazide MR-based therapy in patients with T2DM, as measured by HbA1c changes (in %)

  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)

Study Arms (1)

population description

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female who are treated by Gliclazide MR 60 at index date and who started with SGLT2i added to gliclazide MR with a minimum of 60 days of these combined treatments during the eligibility period

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of diabetes other than T2DM (e.g., type 1, gestational) at index date

Sponsors & Collaborators

• Servier Affaires Médicales: lead

Study Sites (1)

Servier Affaires Médicales

Suresnes, 92284, France

Location

Related Publications (1)

• Moreira RO, Nicodemus NA Jr, Comlekci A, Yu M, Almalki MH. ADD2Dia: Real-World Clinical Effectiveness of Adding a Sodium-Glucose Cotransporter 2 Inhibitor to Gliclazide-Based Therapy in Type 2 Diabetes. Adv Ther. 2025 Dec;42(12):6295-6309. doi: 10.1007/s12325-025-03394-2. Epub 2025 Nov 1.

  PMID: 41175321 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 27, 2024
• Study Start: February 15, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)