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

A Retrospective Chart Review Combined With a Prospective Cross-sectional Survey and Interviews on Patients With Type 2 Diabetes Mellitus to Assess Effectiveness of Adding SodiumGlucose Co-transporter 2 Inhibitor to Gliclazide Modified Release

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06708091
Acronym
ADD2DIA
Enrollment
537
Registered
2024-11-27
Start date
2022-02-15
Completion date
2024-05-31
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

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

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.

Interventions

None listed

Sponsors

Servier Affaires Médicales
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
effectiveness of adding SGLT2i to gliclazide MRfrom 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 %)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026