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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 537
- Locations
- 1
- Primary Endpoint
- effectiveness of adding SGLT2i to gliclazide MR
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
effectiveness of adding SGLT2i to gliclazide MR
Time Frame: 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 %)
Secondary Outcomes
No secondary outcomes reported