voglibose + mitiglinide (Glubes)

Effectiveness of Nutritional Therapy Versus Alpha-Glucosidase Inhibitors in Postprandial Glycemia Control in an Indian Subpopulation of Patients With Type 2 Diabetes: A Prospective Crossover Study.

Shambhukari Praveen Rao PR, Gaddam Anudeep A, Hanchinal Shivaraj S SS

Type 2 diabetes mellitus (T2DM) poses a significant global health challenge, impacting millions of people worldwide. While many studies focus on HbA1c levels, there remains a need to evaluate glycemic variability and postprandial glucose (PPG) excursions. Therefore, this study was conducted to assess and compare the safety and effectiveness of nutritional therapy and alpha-glucosidase inhibitors in achieving rapid PPG stabilization in an Indian subpopulation of patients with T2DM. This short-term open-label study included T2DM patients uncontrolled on metformin and sulfonylurea. The study enrolled 60 participants (40 males, 20 females) with a mean age of 54.06 ± 6.04 years, with the majority being 30-60 years of age (85%). All patients were given intermittent medical nutritional therapy (low glycemic index (LGI) diet) and alpha-glucosidase inhibitors (AGIs; acarbose, voglibose) to manage postprandial glycemia. A rotational design ensured that each group experienced all interventions in varying sequences for a comprehensive analysis of their effects. Glycemic responses were assessed using finger-stick capillary glucose measurements and continuous glucose monitoring (CGM) to evaluate postprandial and 24-hour glycemic variability. Postprandial mean glucose levels were significantly reduced with all interventions (p<0.05), with the highest reduction observed with acarbose. Between AGIs, the adverse effects were similar between medications. The 24-hour mean glucose levels, mean amplitude of glycemic excursion, and area under the curve for 24-hour glycemic fluctuations were significantly lower with interventions, especially acarbose. We conclude that AGIs and LGI diets effectively reduce postprandial glucose, especially in Indian T2DM patients consuming high-carbohydrate diets with a high glycemic load.

Pneumatosis Cystoides Intestinalis Following Voglibose Therapy.

Shan Yuan-Lu YL, Lin Wen-Xiu WX, Xie Wei W

Capivasertib-Induced Diabetes Successfully Managed With Insulin-Independent Glucose-Lowering Agents: A Case Report.

Takeda Ysutaka Y, Tsuyama Mariko M, Haba Yusuke Y, Inokuchi Masafumi M et al.

Capivasertib, an AKT (protein kinase B) inhibitor, in combination with fulvestrant, reduces the risk of progression in recurrent breast cancer; however, it frequently leads to hyperglycemia by disrupting the insulin signaling pathways. Insulin-based therapies are generally ineffective in this setting and may worsen cancer outcomes. Herein, we report a case of capivasertib-induced diabetes successfully managed with insulin-independent glucose-lowering agents while capivasertib therapy was continued. A 57-year-old female with a body mass index of 23.0 kg/m² developed hyperglycemia one month after initiating capivasertib, with a glycosylated hemoglobin (HbA1c) level of 7.3%. A 75-g oral glucose tolerance test (OGTT) confirmed the diagnosis of diabetes according to the American Diabetes Association diagnostic criteria, demonstrating a fasting glucose level of 173 mg/dL, a two-hour glucose level of 512 mg/dL, and marked hyperinsulinemia. The markedly elevated glucose levels observed during the OGTT likely reflect severe drug-induced hyperglycemia associated with AKT inhibition, rather than a typical OGTT response in untreated diabetes. Treatment with empagliflozin (10 mg/day, a sodium-glucose cotransporter-2 inhibitor) and voglibose (0.4 mg/day, an alpha-glucosidase inhibitor) improved the HbA1c level to 6.3% within two months. After five months, a repeat OGTT showed improvement, shifting from the level of diabetes to impaired glucose tolerance, with substantially reduced insulin levels. This case may represent one of the early reports describing the successful management of capivasertib-induced diabetes with insulin-independent glucose-lowering agents, suggesting a potential strategy for managing AKT inhibitor-induced hyperglycemia.

Efficacy and Safety of Glimepiride, Voglibose, and Metformin ER in Type 2 Diabetes: A Randomized, Active-Controlled Study.

Mohan Brij B, Kumar S Vasanth SV, Kurmi Prakash Harishchandra PH, Gupta Sandeep Kumar SK et al.

India ranks second in the global diabetes epidemic, with about 89 million individuals living with Type 2 diabetes mellitus (T2DM). We compared the efficacy and safety of fixed-dose combination (FDC) of glimepiride, voglibose, and extended-release metformin (GLIME+VOGLI+MET-ER) with voglibose and metformin (VOGLI+MET) and glimepiride and metformin (GLIME+MET). A Phase IV, randomized, open-label, active-controlled study was performed in adult patients with T2DM poorly controlled with metformin. Patients received twice daily doses of GLIME+VOGLI+MET-ER (1 + 0.2 + 500 mg: Trivolib 1, 2 + 0.2 + 500 mg: Trivolib 2); or VOGLI+MET (0.2 + 500 mg, 0.3 + 500 mg) or GLIME+MET (1 + 500 mg, 2 + 500 mg). The primary endpoint was the change in HbA1c from baseline. Of the 458 patients screened, 399 were randomized (GLIME+VOGLI+MET-ER [n = 133], VOGLI+MET (n = 135), and GLIME+MET [n = 131]). The mean baseline HbA1c was ~8.35% (~67.77 mmol/mol). All the treatments showed a significant reduction in HbA1c at Weeks 12 and 24. Mean change in % (mmol/mol) HbA1c was significantly more with GLIME+VOGLI+MET-ER versus VOGLI+MET and GLIME+MET at Week 12 (-1.02 ± 0.60 [-11.2 ± 6.52] vs. -0.68 ± 0.64 [-7.49 ± 6.95], p < 0.001 and -0.88 ± 0.49 [-9.65 ± 5.34], p = 0.0154) and Week 24 (-1.57 ± 0.74 [-17.2 ± 8.14] vs. -1.11 ± 0.80 [-12.2 ± 8.79], p < 0.001 and -1.28 ± 0.60 [-14.0 ± 6.56], p = 0.0002). Overall, 49 adverse events (AEs) were reported in 32/399 (8.0%) patients. One patient each in GLIME+VOGLI+MET-ER and VOGLI+MET groups had level 1 hypoglycemia requiring no management. No severe or serious AEs were reported. In adult patients with T2DM inadequately controlled on metformin monotherapy, GLIME+VOGLI+MET-ER demonstrated superior HbA1c reduction compared with VOGLI+MET and GLIME+MET at Weeks 12 and 24. Study medications were safe and well-tolerated. Clinical Trial Registry India-CTRI/2020/11/029080 [Registered on: 12/11/2020].