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voglibose + mitiglinide (Glubes)

✓ Approved

Takeda · GAA · 小分子

什么是 voglibose + mitiglinide？

voglibose + mitiglinide 是一种小分子，由Takeda研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

商品名Glubes
公司Takeda
药物类别小分子
分子靶点GAA, KCNJ11, ABCC8
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, Takeda

作用机制

分子靶点

voglibose + mitiglinide 作用于 3 个分子靶点：

GAAglucosidase alpha, acid (LYAG)
KCNJ11potassium inwardly rectifying channel subfamily J member 11 (BIR, HHF2)
ABCC8ATP binding cassette subfamily C member 8 (MRP8, SUR1delta2)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

voglibose + mitiglinide 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Metabolism and nutrition disordersType 2 diabetes mellitus✓ Approved

相关研究文献

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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PubMedCureus2026-04-23

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.

PMID 42022705
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