Real-World Assessment of Personalized Approach With Voglibose Fixed-Dose Combination in Type 2 Diabetes Mellitus

Nirmal Parmar; Ajay Kumar Gupta; Kunal Jhaveri; Balachandran A; Gaurav Chhaya; Sandeep Kansara; Rathish Nair; Krishnaprasad R Korukonda

doi:10.7759/cureus.57494

Real-World Assessment of Personalized Approach With Voglibose Fixed-Dose Combination in Type 2 Diabetes Mellitus

Cureus. 2024 Apr 3;16(4):e57494. doi: 10.7759/cureus.57494. eCollection 2024 Apr.

Authors

Nirmal Parmar¹, Ajay Kumar Gupta², Kunal Jhaveri³, Balachandran A⁴, Gaurav Chhaya⁵, Sandeep Kansara⁶, Rathish Nair⁷, Krishnaprasad R Korukonda⁷

Affiliations

¹ Department of Internal Medicine, Prisha Medical Care, Ahmedabad, IND.
² Department of Internal Medicine, Madhumeha Clinic, New Delhi, IND.
³ Department of Internal Medicine, Vishesh Clinic of Internal Medicine, Ahmedabad, IND.
⁴ Department of Diabetology, ABC Medical Centre, Erode, IND.
⁵ Department of Internal Medicine, Shivam Medi Care Clinic, Ahmedabad, IND.
⁶ Department of Endocrinology, Dr. Sandeep Kansara's Diabetes, Thyroid, and Hormone Clinic, Udaipur, IND.
⁷ Department of Medical Strategic Affairs, Torrent Pharmaceuticals Ltd., Ahmedabad, IND.

Abstract

Background: Post-prandial hyperglycemia (PPHG) remains a complex aspect in the management of type 2 diabetes mellitus (T2DM) in the Indian population due to uncertainty in the optimal utilization of alpha-glucosidase inhibitors (AGIs) either as standalone therapy or in combination, whether initiated initially or as a sequential therapy.

Methods: This was a post-approval, observational, multicentric clinical study conducted at 50 centers according to principles of the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (ICH-GCP) and Declaration of Helsinki and local ethics approval. Descriptive and analytical statistics were applied for conclusion and categorical variables using SPSS version 29.0.1.0 (171) (Armonk, NY: IBM Corp.).

Results: Protocol analyses of 515 cases revealed baseline demographics as follows: age 57.35±10.04 years, weight 72.86±10.92 kg, and BMI 28.33±6.07 kg/m². Comorbidities included hypertension (N=169, 32.82%), thyroid disorders (N=99, 19.22%), and heart failure (N=92, 17.86%). Concomitant oral antidiabetics (OADs) prescribed as DPP4i (9.50%), SGLT2i (19.20%), and DPP4i+SGLT2i (7.20%). Study drug reduced glycosylated hemoglobin (HbA1c) by 13.77% (1.25% mean change, p<0.01), fasting blood glucose (FBG) by 23.69% (44.61 mg/dL mean change, p<0.01), post-prandial blood glucose (PPBG) by 24.57% (70.46 mg/dL mean change, p<0.01), and body weight by 4.43% (3.21 kg mean change, p<0.01) over 12 weeks. A total of 161 patients accomplished targeted PPBG of <180 mg/dL (119.13 mg/dL mean change, p<0.01). Regression analysis considering PPBG and HbA1c ≤7.5% showed a weak correlation between them (R-value=0.13, R-squared value=0.02), whereas between PPBG and HbA1c ≤9% yielded moderate positive correlation (R-value=0.53, R-squared value=0.28). There were no adverse events reported or analyzed during the observation period.

Conclusion: Voglibose fixed-dose combination (FDC) demonstrates significant effectiveness at the initial dosage when started early in the management of T2DM and high PPBG levels. Moreover, it exhibits good tolerability, thereby contributing to higher compliance among Indian patients who consume a high-carbohydrate diet.

Keywords: fbg; fixed-dose combination; hba1c; ppbg; trivoglitor; type 2 diabetes mellitus.

Grants and funding

The study was funded by Torrent Pharmaceuticals Ltd., Ahmedabad, India.