• The first large-scale, long-term RCT conducted in the Chinese population confirmed that Glucobay®(Acarbose) On the basis of lifestyle intervention, it can significantly reduce the risk of new-onset diabetes in people with prediabetes;
• ACE is the largest study on prediabetes intervention in China to date, ushering in a new era of diabetes prevention in China;
• Glucobay®(Acarbose) is the only glucose-lowering drug proven in China to prevent and delay the progression of impaired glucose tolerance (IGT) to diabetes, and it holds an indication for IGT.
September 14, 2017 – Bayer today announced that results from the ACE study, presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD), showed that Chinese patients with coronary heart disease and impaired glucose tolerance (IGT), when receiving lifestyle interventions as recommended by guidelines, were treated with the oral antidiabetic medication Glucobay®(Acarbose) treatment can significantly reduce the risk of new-onset diabetes, while Glucobay®(Acarbose) also demonstrated an excellent safety profile. The landmark ACE study will usher in a new era of diabetes prevention in China, with its research data published concurrently in The Lancet Diabetes & Endocrinology.
The latest epidemiological data on diabetes and prediabetes in China show that the prevalence of diabetes among Chinese adults was 10.9% in 2013, while the prevalence of prediabetes reached 35.7%. Impaired glucose tolerance (IGT) refers to a state of hyperglycemia characterized by normal fasting blood glucose levels and 2-hour postprandial blood glucose levels between 7.8 and 11.1 mmol/L, representing the most common manifestation of prediabetes. “During the prediabetic stage, the typical ‘three polys and one loss’ symptoms of diabetes are often not apparent.” The 20-year follow-up results of the Da Qing Study indicated that without timely detection and treatment during the IGT stage, 92.8% of individuals would progress to diabetes, and their risk of developing cardiovascular disease would already be increased by two to three times.
Professor Pan Changyu from the Chinese People's Liberation Army General Hospital, co-chair of the ACE study, pointed out: "The ACE study is a randomized, double-blind, multicenter, placebo-controlled trial conducted at more than 150 research centers across mainland China and Hong Kong. The study included a total of 6,526 patients with coronary heart disease (CHD) combined with impaired glucose tolerance (IGT). Officially launched in 2008 and spanning nearly 10 years, it is the largest intervention study on prediabetes in China to date."
Professor Rury Holman, Head of the Diabetes Trials Unit at the University of Oxford, provided a detailed overview of the study design and results. “Patients enrolled in the ACE study received either acarbose 50 mg t.i.d. or placebo, in addition to lifestyle interventions as recommended by guidelines, with a median follow-up of 5.0 years. The results showed that the risk of new-onset diabetes was 18% lower in the Glucobay® group (13.3%) than in the control group (15.8%), a statistically significant difference (RR 0.82, 95% CI 0.71–0.94; P = 0.005).”
The study also evaluated whether acarbose could reduce the risk of future cardiovascular events in such patients; however, no statistically significant difference was observed. The researchers attributed this outcome to the 50 mg dose used in the ACE study and the insufficient duration of follow-up. Furthermore, the researchers posited that since diabetes itself significantly increases cardiovascular risk, preventing diabetes will ultimately reduce the incidence of cardiovascular events in the long term. Regarding adverse reactions, there were no significant differences in the incidence of mild and severe hypoglycemia between the acarbose group and the control group (mild hypoglycemia: 22.0% vs. 20.4%; severe hypoglycemia: 2.0% vs. 1.9%). Similarly, no significant difference was observed in the incidence of renal impairment (1.3% vs. 1.5% in the control group, P = 0.33). The incidence of gastrointestinal adverse events was only 7.7%, showing no significant difference compared to 5.5% in the placebo group. These findings further confirm the excellent safety profile of Glucobay®.
Professor Hu Dayi, a renowned cardiovascular expert in China and co-chair of the ACE study, pointed out: “China is a country with a large diabetic population. The ‘Healthy China 2030’ Planning Outline emphasizes that adhering to prevention as the priority, reducing disease incidence, and strengthening early diagnosis, early treatment, and early rehabilitation are central to building a Healthy China. Following the Da Qing Study, which first demonstrated that lifestyle interventions effectively reduce the risk of new-onset diabetes in individuals with impaired glucose tolerance (IGT), the ACE study provides further robust evidence for diabetes prevention in China: pharmacological intervention significantly reduces the risk of new-onset diabetes in the IGT population. This is the first study led by Chinese experts, involving a global research team, and conducted entirely among the Chinese population, marking another contribution from China to the field of global diabetes prevention.”
Dr. Lang Zhihui, Vice President of the China Medical Department at Bayer Pharmaceuticals, stated, “Acarbose has been marketed in China for over 20 years. Its unique mechanism of action aligns well with the carbohydrate-rich dietary patterns of the Chinese population. Acarbose is the only glucose-lowering medication in China approved for the indication of impaired glucose tolerance (IGT). The ACE study, the first large-scale, long-term trial conducted specifically in the Chinese population, confirmed that acarbose significantly prevents new-onset diabetes while demonstrating an excellent safety profile—a critical attribute for preventive medications. Acarbose offers a new therapeutic option for preventing diabetes among individuals with prediabetes in China. As an active promoter of chronic disease management in China, Bayer remains committed to providing high-quality medicines to Chinese patients, while actively engaging in academic collaborations and scientific innovation to reduce disease incidence and effectively alleviate the disease burden.”