ArticleCureus2026
A Randomized, Multicenter Study Evaluating the Efficacy, Safety and Tolerability of Dapagliflozin + Gliclazide Fixed Dose Combination Over Dapagliflozin Monotherapy in Type 2 Diabetes Mellitus Patients Inadequately Controlled on Metformin Monotherapy.
Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background Sodium glucose transporter 2 inhibitors (SGLT2i) and sulfonylurea (SU) offer an additive mechanism of action, potentially enhancing glycemic control in patients inadequately managed with metformin monotherapy. This study compared the efficacy and safety of a fixed-dose combination (FDC) of dapagliflozin and gliclazide sustained release (SR) in patients with type 2 diabetes mellitus (T2DM) poorly controlled with metformin monotherapy. Methods This multicentric, prospective, randomized, open-label, parallel-group, phase III clinical study was carried out at several sites around India. A total of 244 T2DM patients were randomized in a 1:1 ratio to receive either dapagliflozin 10 mg + gliclazide 60 mg SR (test arm) or dapagliflozin 10 mg (reference arm) for 16 weeks. The primary endpoint was the adjusted mean change from baseline in glycated hemoglobin A1c (HbA1c) at the end of week 16. Results In both arms, the baseline mean HbA1c was 8%. From baseline to week 16, the adjusted mean reduction in HbA1c was statistically significant in the FDC combination of dapagliflozin and gliclazide SR compared to dapagliflozin, with a change in mean HbA1c levels from baseline of 8.76% to 6.97% (SD: 1.02%; p-value < 0.001) and 8.80% to 7.32% (SD: 1.24%; p-value < 0.001), respectively. The FDC was well-tolerated with a favorable safety profile. Conclusion The FDC of dapagliflozin 10 mg and gliclazide 60 mg SR proved to be efficacious and exhibited a favorable safety profile in patients with T2DM poorly controlled with metformin compared to dapagliflozin 10 mg monotherapy.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.