NCT06708091Completed
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
Source: ClinicalTrials.gov · Last updated 27 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 537 (actual)
- First submitted
- 22 Nov 2024
- Start date
- 15 Feb 2022
- Primary completion date
- 31 May 2024
- Lead sponsor
- Servier Affaires Médicales
- Diseases
- Type 2 diabetes
- NCT number
- NCT06708091
What you commit to
- Study type: Observational
- Participants enrolled: 537
- From 15 Feb 2022 to the primary completion date, 31 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antidiabetic drugs other than those permitted by the inclusion criteria, at index date
Other illness
- Diagnosis of diabetes other than T2DM (e.g., type 1, gestational) at index date
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Servier Affaires Médicales Coordinator of this site? Confirm its status | Suresnes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.