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Prospective Multicenter Observational Study of Voglibose in Type 2 Diabetes — VICTORY

1. Bharti Hospital, Karnal, India; 2. Aruna Diabetes Centre, Chennai, India; 3. Advanced Diabetes Centre Pvt. Ltd., Surat, India; 4. Endocare, Hyderabad, India; 5. Diabetes Obesity & Thyroid Centre, Gwalior, India; 6. Dr Sambit's Centre of Diabetes and Endocrinology, Bhubaneswar, India; 7. Diabetes Care Centre, Ranchi, India; 8. Diabetes Care Centre, Allahabad, India; 9. Torrent Pharmaceuticals Ltd., Ahmedabad, India


US ENDOCRINOLOGY
India, being an epicentre of diabetic population, has faced an increase in disease-prevalence of more than double over the past 15 years, and is projected to have about 123.5 million cases by the year 2040. 1 In addition to achieving target glycated hemoglobin (HbA1c) <7%, intensive control of blood glucose levels is important in order to retard or arrest the development and progression of the microvascular complications of diabetes. Changes in postprandial blood glucose (PPBG) levels precede those in fasting blood glucose (FBG) and finally in HbA1c. Hence, the management of both FBG and PPBG is critical to achieving full glycemic control; 2 the latter often being more challenging to achieve. 3 Voglibose, an alpha-glucosidase inhibitor, reduces PPBG when used alone or in combination with other antidiabetic drugs. Its efficacy and safety have been well established in multiple randomized controlled trials (RCTs), which conclude it to be an effective oral antidiabetic drug (OAD) with a good tolerability profile and cardiovascular benefits. 4,5 The design of RCTs, often considered the gold standard for evaluating the safety and efficacy of therapeutic agents, necessitates strict eligibility criteria for patient inclusion, which questions the representability of the study population to that encountered in clinical practice.

Endpoints
The primary endpoint was mean change in HbA1c levels from baseline to week 12. Secondary endpoints were mean change in FBG, PPBG, and body weight from baseline to week 12; the usage patterns for voglibose (monotherapy or add-on therapy with other OADs); and adverse events (AEs) reported during the study period. AEs were classified as mild (no interference with usual activity), moderate (significant interference with usual activities), and severe (prevents usual activities).

Statistical analysis
Considering the large sample size, it was assumed that data were normally distributed according to the central limit theorem. Continuous variables were reported as mean and standard deviation (SD) and categorical variables were presented as absolute frequency and percentage. The data were analyzed, and the mean change in HbA1C, FBG, PPBG and weight along with SD were subjected to statistical analysis using paired t-test with a significance value of 5%. The safety review was performed using intent-to-treat dataset (all participants who were recruited in the study irrespective of study completion), while efficacy analysis was performed using per protocol dataset (all participants who completed the study as per the protocol).

Results
A total of 1,542 participants were enrolled in the study; of these 1,365 participants (88.5%) completed the study ( Figure 1). The mean age and body weight of the study participants were 53.7 years (SD 11.0) and was not significant at week 12 ( Figure 4).

Baseline
Week 12

Baseline
Week 12  Most participants (74.7%) in our study were taking multiple antidiabetic agents. Voglibose was most commonly used as add-on to metformin and sulfonylureas (28.8%)-a finding seen in several clinical trials of patients with T2DM treated with voglibose as add-on therapy.  Twelve-week treatment with voglibose resulted in significant reduction in HbA1c (0.98%, p<0.001). Similar reductions in HbA1c with monotherapy or add-on therapy with voglibose have been reported in randomized studies. In a 6-month, single-blind, randomized, prospective study that compared voglibose with miglitol and acarbose, voglibose (0.2 mg three times daily for 1 month followed by 0.3 mg three times daily for 3 months) significantly reduced HbA1c by 1.57%. 14 17 and Jindal et al., 15 respectively, while it is higher than the reported reduction of 24.9 mg/dL in the study by Talaviya et al. 16 In the present study, significantly higher reduction of FBG Differences seen between the results of this study and that of the ones by Talaviya et al. 16 could be explained by the retrospective nature, obese patient population, and small sample size (n=77) of the latter.
In our experience, voglibose monotherapy or add-on therapy was safe for use in participants with T2DM, with no serious AEs reported.
Flatulence and abdominal discomfort were the most commonly reported AEs and most AEs were of mild intensity. This is consistent with the safety and tolerability of voglibose reported in several studies. 14,17,16,[19][20][21] However, the under-reporting of safety events, as suggested by the low rates of AEs, is a common problem in observational studies. 7,17,22 In contrast to RCTs, the data collection of AEs was based on voluntary reporting by the investigators, who are more likely to report serious AEs in clinical practice.   The short observation period and the lack of a control group are the main limitations of this study. However, the latter increases the propensity of the results to be more generalizable and replicable in clinical practice, which is necessary to complement the information retrieved from RCTs.
Real-life studies and RCTs both have strengths and limitations, and those should be appreciated as complementary to one another.
The strength of the VICTORY study is the large sample size from multiple real-life set-ups across India. This clearly supports widespread use of voglibose in patients with T2DM in real-world practice. Additionally, it also indicates the enthusiasm and interest of both patients and healthcare professionals to be part of such undertakings. Having excluded the non-qualifying and incomplete data, we tried to optimize the quality of the data, which were utilized for the final analysis in this study.

Conclusions
The VICTORY study demonstrates the real-life effectiveness of voglibose monotherapy or add-on therapy, which significantly reduced HbA1c, FBG, and PPBG in patients with T2DM. Voglibose was most commonly added with metformin and sulfonylureas. It was well-tolerated by the participants with T2DM without significant weight change. The efficacy of voglibose in a large population with T2DM seen in this study is the real-world reflection of the results obtained in randomized trials.