Voglibose for prevention of type 2 diabetes mellitus: a randomised, double-blind trial in Japanese individuals with impaired glucose tolerance
Abstract
Background The increased prevalence of type 2 diabetes mellitus is a major concern for health providers. We therefore assessed whether voglibose, an alpha-glucosidase inhibitor, could prevent the development of type 2 diabetes in high-risk Japanese individuals with impaired glucose tolerance.Methods 1780 eligible patients on a standard diet and taking regular exercise with impaired glucose tolerance were randomly assigned to oral voglibose 0.2 mg three times a day (n=897) or placebo (n=883) in a multicentre, double-blind, parallel group trial. Treatment was continued until participants developed type 2 diabetes (primary endpoint) or normoglycaemia (secondary endpoint), or for a minimum of 3 years, subject to the findings of an interim analysis. Analysis was by full analysis set. This trial is registered with the University Hospital Medical Information Network (UMIN) clinical trials registry, number UMIN 000001109.Findings In the interim analysis, voglibose was better than placebo (p=0.0026) in individuals treated for an average of 48.1 weeks (SD 36.3). Patients treated with voglibose had a lower risk of progression to type 2 diabetes than did those on placebo (50 of 897 vs 106 of 881; hazard ratio 0.595, 95% CI 0.433-0.818; p=0.0014). More people in the voglibose group achieved normoglycaemia than did those in the placebo group (599 of 897 vs 454 of 881; 1.539, 1.357-1.746; p<0.0001). 810 (90%) of 897 patients in the voglibose group had adverse events versus 750 (85%) of 881 in the placebo group. Serious adverse events (all one each) in the voglibose group were cholecystitis, colonic polyp, rectal neoplasm, inguinal hernia, liver dysfunction, and subarachnoid haemorrhage, and in the placebo group were cerebral infarction and cholecystitis.Interpretation Voglibose, in addition to lifestyle modification, can reduce the development of type 2 diabetes in high-risk Japanese individuals with impaired glucose tolerance.Funding Takeda.
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Two large trials support the effectiveness of α-glucosidase inhibitors in the prevention of diabetes, and one of them also shows evidence of decreased CVD and hypertension risk among treated IGT patients.
“However, two large trials support the effectiveness of these drugs in the prevention of diabetes and importantly one of them also shows evidence of decreased CVD and hypertension risk among treated IGT patients.102,103”
From Prediabetes: a high-risk state for diabetes development (2012) · cites this paper as [102]
A recent study investigating voglibose found a 40% reduction in incident diabetes risk over 48 weeks of follow-up among high-risk Japanese individuals with IGT, with gastrointestinal side effects similar to previous trials but more people completing the study.
“A recent study investigating voglibose, another α-glucosidase inhibitor, found a 40% reduction in incident diabetes risk over 48 weeks of follow-up among high-risk Japanese individuals with IGT. Although the gastrointestinal side effects were similar as reported in previous trials, more people completed that study.102”
From Prediabetes: a high-risk state for diabetes development (2012) · cites this paper as [102]
In a trial in Japan, voglibose 0.2 mg tid reduced incident diabetes by 41% compared with placebo.
“Voglibose (0.2 mg tid) treatment reduced incident diabetes 41% compared to placebo in a trial in Japan.202”
From The Vasculature in Prediabetes (2018) · cites this paper as [202]
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References 32 · Cited by 303
- Authors
- Kawamori, R., Tajima, N., Iwamoto, Y., Kashiwagi, A., Shimamoto, K., & Kaku, K.
- Affiliations
- Juntendo University (JP)
- Jikei University School of Medicine (JP)
- Tokyo Women's Medical University (JP)
- Shiga University of Medical Science (JP)
- Sapporo Medical University (JP)
- Kawasaki Medical School (JP)
- Corresponding author
- Kawamori, Ryuzo
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2009-05
- Volume
- 373
- Issue
- 9675
- Pages
- 1607-1614
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W1978288432
- Cited by
- 303
- References
- 32
- Citations by year
- 2026: 5 · 2025: 13 · 2024: 11 · 2023: 8 · 2022: 15 · 2021: 13 · 2020: 16 · 2019: 19 · 2018: 24 · 2017: 17 · 2016: 16 · 2015: 23 · 2014: 22 · 2013: 18 · 2012: 32
- FWCI
- 19.91
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Takeda Pharmaceutical Company
- Eli Lilly and Company
- Astellas Pharma US
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Natural Antidiabetic Agents Studies
- Keywords
- type 2 diabetes prevention, impaired glucose tolerance, alpha-glucosidase inhibitors, Japanese population, lifestyle modification, normoglycemia, adverse events, cholecystitis, liver dysfunction, subarachnoid hemorrhage, rectal cancer, colonic polyps, cerebral infarction
- MeSH terms
- Administration, Oral, Analysis of Variance, Diabetes Mellitus, Type 2, Double-Blind Method, Female, Humans, Hypoglycemic Agents, Inositol, Japan, Life Style, Male, Middle Aged, Severity of Illness Index, Incidence, Prevalence, Proportional Hazards Models, Glucose Intolerance, Disease Progression, Risk Assessment, Risk Reduction Behavior, Kaplan-Meier Estimate, Glycoside Hydrolase Inhibitors
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