ArticleAdvances in therapy2026
Efficacy and Safety of Dapagliflozin, Glimepiride, and Metformin Fixed-Dose Combination Tablet in Type 2 Diabetes: A Phase III Trial.
Article in Advances in therapy, 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
27 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe global burden of type 2 diabetes mellitus (T2DM) is rapidly increasing, with India contributing significantly to the disease prevalence and associated economic burden. Despite metformin being the first-line therapy, many patients require combination treatment due to the progressive and multifactorial nature of T2DM. Fixed-dose combinations (FDCs) of drugs with complementary mechanisms may improve glycemic control, adherence, and treatment outcomes. This study has evaluated efficacy and safety of FDC of dapagliflozin (DAPA), glimepiride (GLIM), and metformin (MET) immediate release (IR) tablet versus co-administration of GLIM and MET tablets in patients with T2DM.
methodsThis phase 3, randomized, open-label study included 536 Indian patients with T2DM [glycated hemoglobin (HbA1c) ≥ 8.0% and ≤ 11%], randomized (1:1:1:1) into four arms in primary treatment period (up to Week 16): FDC of DAPA + GLIM + MET [5 mg+1 mg+500 mg (Test 1)] or [5 mg+1 mg+1000 mg (Test 2)] twice-daily, or co-administration of GLIM and MET (1 mg and 500 mg) (Comparator 1) or GLIM and MET (1 mg and 1000 mg) (Comparator 2) twice-daily. Patients with HbA1c ≥ 7.0% at week 16 entered an uptitration period (increased GLIM dose to 2 mg; Weeks 16-28). Change in HbA1c from baseline to Week 16 was the primary endpoint.
resultsAt Week 16, least-square mean HbA1c reduction was significantly greater with Test 1 (- 2.17%) versus Comparator 1 (- 1.64%, p = 0.0047) and Test 2 (- 2.25%) versus Comparator 2 (- 1.72%, p < 0.0001). Similarly, the proportion of patients achieving HbA1c < 7.0% at Week 16 was significantly greater in Test 1 versus Comparator 1 and Test 2 versus Comparator 2 (p < 0.0002 and p < 0.0001, respectively). Reduction in HbA1c, fasting, and postprandial blood glucose from baseline to Weeks 12, 16, and 28 was significant in all arms. Overall, treatments were well tolerated.
conclusionsThe FDC of DAPA + GLIM + MET IR tablet demonstrated superior glycemic control over co-administration of glimepiride and metformin and acceptable safety profile, making it an effective therapeutic option for T2DM management.
trial registrationClinical Trials Registry India, CTRI/2022/06/043249.
Indexed as
Identifiers
42970163What OpenQuestion 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 OpenQuestion graph.