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voglibose + mitiglinide (Glubes)

✓ Approved

Takeda · GAA · Small Molecule

What is voglibose + mitiglinide?

voglibose + mitiglinide is a small molecule developed by Takeda. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesGlubes
CompanyTakeda
Drug ClassSmall Molecule
Molecular TargetGAA, KCNJ11, ABCC8
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Takeda

Mechanism of Action

Molecular Targets

voglibose + mitiglinide acts on 3 molecular targets:

GAAglucosidase alpha, acid (LYAG)
KCNJ11potassium inwardly rectifying channel subfamily J member 11 (BIR, HHF2)
ABCC8ATP binding cassette subfamily C member 8 (MRP8, SUR1delta2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

voglibose + mitiglinide is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Metabolism and nutrition disordersType 2 diabetes mellitus✓ Approved

Related Research Articles

PubMedCureus2026-08-28

A Comparative Study to Evaluate the Renoprotective Effect of Antidiabetic Drugs in Patients With Type 2 Diabetes Mellitus.

Pichholiya Meenu M, Abhinav Raj R, Singh Sakshi S, Yadav Arvind K AK et al.

Type 2 diabetes mellitus (T2DM) is a metabolic condition that often leads to long-term microvascular and macrovascular complications. Among its most frequent and severe complications is diabetic nephropathy, which stands as a primary contributor to chronic kidney disease and end-stage renal disease on a global scale. Literature search studies have exhibited both renoprotective and non-renoprotective effects of different antidiabetic drugs, and to our knowledge, no study comparing the renoprotective effect of antidiabetic drugs was found, so this study was designed to assess the impact of these drugs on kidney function in patients with T2DM. A prospective observational study was carried out on 100 patients with T2DM at a tertiary care hospital after approval from the institutional ethics committee. Informed consent was obtained from all patients. Patients aged ≥18 years receiving antidiabetic therapy were included in the study. Data, including demographic details, ongoing antidiabetic treatment, and clinical parameters, were recorded and analyzed according to the prescribed drug therapy. Glycemic control was assessed using HbA1c levels, while renal function was evaluated using renal parameters at baseline and during follow-up visits. The data was analyzed using IBM SPSS Statistics for Windows, Version 20 (Released 2011; IBM Corp., Armonk, New York, United States). A student's t-test and ANOVA were applied as appropriate, and a p-value < 0.05 was considered statistically significant. Patients receiving metformin and gliptin therapy showed a statistically significant reduction (p < 0.05) in HbA1c levels and mean serum urea during the study period. Serum creatinine levels were found to be slightly higher than the normal range in all the groups except metformin-based combination therapy with sulfonylureas and metformin-based combination therapy with sulfonylureas plus voglibose at the first visit. The values dropped down gradually in subsequent visits in all the groups except in the insulin group and the metformin-with-voglibose group, but were not statistically significant. A significant reduction was observed in the group taking metformin with sodium-glucose cotransporter 2 (SGLT2) inhibitors and gliptins. Renal function tests, such as serum urea and serum creatinine levels, showed significant changes during all three subsequent follow-ups. Proper use of antidiabetic drugs, particularly oral combination therapy, not only improves blood sugar control but also helps in protecting kidney function in diabetic patients. Future investigations with large sample sizes and longer observation periods are warranted to substantiate these findings.

PMID 42662112
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PubMedThe Journal of the Association of Physicians of India2026-08-03

Expert Consensus and Physician Perspectives on a Low-dose Triple Fixed-dose Combination for Type 2 Diabetes in India.

Kesavadev Jothydev J, Unnikrishnan A G AG, Saboo Banshi B, George Joe J et al.

Fixed-dose combinations (FDCs), particularly sulfonylurea-based triple therapies, play a central role in managing type 2 diabetes in India. With growing focus on safety and personalization, lower-dose alternatives are gaining attention, especially for early-stage and vulnerable patients. To obtain expert consensus from Indian physicians on the clinical relevance, preferred patient profiles, and prescribing intent for a low-dose triple FDC comprising glimepiride 0.5 mg, metformin 500 mg sustained-release (SR), and voglibose 0.2 mg. A structured cross-sectional survey was conducted among 112 physicians from metro and nonmetro regions of India. The survey used close- and open-ended questions to explore the need, clinical positioning, and use scenarios for this low-dose triple combination. Responses were analyzed and synthesized into expert consensus per the Oxford Centre for Evidence-Based Medicine (OCEBM) framework (Level V evidence). Most physicians (86.6%) supported the need for this combination. Common use cases included early-stage diabetes, elderly patients, and those with postprandial hyperglycemia or hypoglycemia risk. It was also preferred for step-up therapy and deintensification with agents, such as SGLT2 inhibitors or insulin (77.7%). Advantages cited included improved safety, simplified dosing, and affordability. Expert consensus affirms this FDC's clinical relevance across multiple diabetes stages. Further real-world evidence and outcome-driven studies are warranted to support broader clinical integration and guideline inclusion.

PMID 42543954
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PubMedRapid communications in mass spectrometry : RCM2026-08-02

Integrated 1D-LC-HRMS and Heart-Cutting 2D-LC-MS for Impurity Profiling and Chiral Separation of Mitiglinide Drug Substance.

Wang Chenxi C, Zhou Shiwen S, Sun Wanhao W, Pan Yuanjiang Y et al.

The comprehensive quality control of chiral pharmaceuticals like mitiglinide necessitates simultaneous assessment of chemical impurities and enantiomeric purity, yet conventional workflows address these separately, leading to inefficiency. This study develops a comprehensive analytical strategy to overcome this challenge for the anti-diabetic drug mitiglinide. For chiral analysis, an online heart-cutting two-dimensional liquid chromatography-high-resolution mass spectrometry (2D-LC-HRMS) method was developed. First, impurity profiling of mitiglinide was accomplished using a one-dimensional reversed-phase LC-HRMS (1D-LC-HRMS) method. Subsequently, the 2D-LC-HRMS system achieved enantiomer separation by online coupling of a C18 column (first dimension) with a polysaccharide-based chiral column (second dimension), with the separated analytes detected by an Orbitrap mass spectrometer. 1D-LC-HRMS identified five major impurities, structurally characterizing four, with the main component accounting for only 49.12% of the total integrated peak area (relative abundance by EIC peak area normalization, not absolute purity). The 2D-LC-HRMS method achieved effective enantiomer separation. A consistent third minor chromatographic peak was observed across six replicate analyses, which is tentatively assigned as a potential diastereomeric impurity based on stereochemical interpretation of the chromatographic behavior; confirmatory evidence is required for definitive identification. This work successfully establishes a comprehensive strategy that efficiently consolidates impurity profiling and chiral purity assessment for mitiglinide. It provides a reliable, more informative approach for the quality control of complex chiral pharmaceuticals.

PMID 42541332
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PubMedFrontiers in endocrinology2026-06-22

Case Report: Voglibose-induced persistent leukopenia in a patient with type 2 diabetes.

Guo Jing-Wen JW, Yan Jin-Hong JH, Chang Li-Shuang LS, Cai Shuang S et al.

While alpha-glucosidase inhibitors like voglibose are generally considered safe, hematological adverse effects such as leukopenia are exceedingly rare. This case report investigates a potential causal link between long-term voglibose use and persistent leukopenia in a diabetic patient, emphasizing the importance of considering drug-induced cytopenia in unexplained leukopenia. We describe a 71-year-old male with well-controlled type 2 diabetes who developed leukopenia over five years. After extensive evaluation, including bone marrow biopsy showing hypoplasia, and ineffective leukopoietic treatment, a multidisciplinary review identified long-term voglibose use as a possible cause. The drug was replaced with acarbose. Two weeks after switching to acarbose, the patient's white blood cell count rose from a persistent range of 2.69-3.32 × 109/L to 3.89-3.98 × 109/L, without other interventions. The temporal association and a Naranjo score of 7 supported voglibose as the probable cause of leukopenia. This case suggests that voglibose may rarely induce chronic leukopenia, especially with prolonged use. In diabetic patients with unexplained cytopenia, clinicians may consider medication review and therapeutic substitution as a diagnostic and management strategy.

PMID 42325631
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PubMedCureus2026-05-11

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.

PMID 42110014
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PubMedDeutsches Arzteblatt international2026-05-07

Pneumatosis Cystoides Intestinalis Following Voglibose Therapy.

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

PMID 42093376
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