Fig 1.
A total of 1235 patients with type 2 diabetes mellitus (T2DM) were included at baseline. All patients completed Visit 1 and Visit 2 assessments, with no loss to follow-up. Consequently, 1235 patients completed the study and were included in the per-protocol (PP) dataset analysis.
Table 1.
Patient demographics and baseline characteristics. Patient history including demographics, family history, disease duration, identifiable risk factors, comorbid conditions, and complications.
Fig 2.
HbA1c improvement from baseline to 12 weeks of treatment.
Mean change in HbA1c levels from baseline (Day 0) to 12-week follow-up in patients with type 2 diabetes mellitus (T2DM) receiving triple fixed-dose combination therapy. Bars represent mean values and error bars indicate standard deviation (SD). Mean value significantly decreased from 8.20 ± 0.60 at baseline to 7.06 ± 0.76 at follow-up showing a mean change (Δ) of −1.13 (p < 0.0001).
Fig 3.
Improvement in baseline efficacy parameters post treatment with study drug.
Mean Change in fasting blood glucose (FBG), 1-hour postprandial glucose (PPG), 2-hour PPG and body weight from baseline (Day 0) to follow-up visits at 4 weeks and 12 weeks. Bars represent mean values and error bars indicate standard deviation (SD). Significant reductions were observed across all parameters at 12 weeks compared with baseline (p < 0.0001). Mean changes (Δ) from baseline were −42.01 mg/dL for FBG, −65.81 mg/dL for 1-hour PPG, −55.34 mg/dL for 2-hour PPG and −2.48 kg for body weight.
Fig 4.
Responder’s rate in overall patients after 12 weeks of treatment.
Responder rates for glycaemic parameters (HbA1c, fasting blood glucose [FBG], 1-hour postprandial glucose [PPG-1h], 2-hour postprandial glucose [PPG-2h]) and body weight from baseline to 12 weeks of follow-up. Bars represent the proportion of patients achieving clinically meaningful improvements in each parameter. Δ values denote the mean change from baseline. Statistically significant improvements were observed across all parameters (p < 0.0001).
Table 2.
Multivariate regression analysis. Multivariate analysis of predictors influencing glycaemic and clinical outcomes. Results are presented as Wilks’ Lambda values with corresponding significance levels. Lower Wilks’ Lambda indicates stronger predictive effect on multivariate outcomes.
Table 3.
Changes in clinical and biochemical parameters from baseline to follow-up visits. Data are presented as mean paired differences with standard deviation, standard error of mean, 95% confidence intervals, and two-sided p-values. Parameters assessed include body weight, HbA1c, fasting blood glucose (FBG), postprandial glucose (PPG at 1h and 2h), serum creatinine, and serum albumin. Subgroup analyses were performed as a post hoc for patients with BMI < 23 and BMI ≥ 23. All p-values <0.0001 indicate statistically significant improvements compared to baseline.