Efficacy and safety of acarbose chewable tablet in patients with type 2 diabetes: a multicentre, randomized, double‐blinded, double‐dummy positive controlled trial

Wu, Qian; Liu, Yu Ping; Ju, Lu; Wang, Changjiang; Yang, Tao; Dong, Ji; Li, Cheng Jiang; Jiang, Hua; Xue, Yao; Sun, Rui; Dong, Wei; Tian, Hua

doi:10.1111/j.1756-5391.2012.01188.x

Cited by 5 publications

(8 citation statements)

References 10 publications

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“…However, the efficacy of acarbose in reducing 2-h postprandial glucose was greater than that of metformin. Similar results were reported by Rosenstock et al [ 15 ] and Wu et al [ 16 ].…”

Section: Discussionsupporting

confidence: 91%

Factors That Influence Pancreatic Beta Cell Function and Insulin Resistance in Newly Diagnosed Type 2 Diabetes Patients: A Sub-Analysis of the MARCH Trial

Duan

Liu

et al. 2018

Diabetes Ther

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IntroductionThe Metformin and Acarbose in Chinese as the initial Hypoglycemic treatment (MARCH) trial has demonstrated a similar efficacy in HbA1c reduction between acarbose and metformin treatments in newly diagnosed type 2 diabetes mellitus (T2DM) patients. The current sub-analysis of the MARCH trail aims to evaluate the baseline characteristics that may influence the improvement of pancreatic β-cell function and insulin resistance after acarbose therapy in Chinese patients with newly diagnosed T2DM.MethodsOf the 784 patients who entered the MARCH trail, 391 were assigned to the acarbose therapy group; 304 of these completed 48 weeks of follow-up of acarbose therapy. At 48 weeks, on the basis of the tertiles of change in homeostasis model assessment–beta cell function (∆HOMA-β) and homeostasis model assessment–insulin resistance (∆HOMA-IR), the subjects were divided into lowly, mediumly, and highly improved groups.ResultsIn the highly improved HOMA-β group, patients had higher systolic blood pressure (SBP), 2-h postprandial blood glucose (PBG), hemoglobin A1c (HbA1c), and lower high-density lipoprotein cholesterol (HDL-c), fasting serum insulin (FINS) concentration, and HOMA-IR in comparison to the lowly improved group (p < 0.05). A positive correlation was observed between HbA1c, SBP, and highly improved ∆HOMA-β (p < 0.05), while an inverse correlation was evident between HDL-c and highly improved ∆HOMA-β (p < 0.05). The highly improved HOMA-IR group had a significantly higher body mass index (BMI), fasting blood glucose (FBG), FINS concentration, and HOMA-β in comparison to the lowly improved group (p < 0.05). A positive correlation was observed between FBG, waist circumference, and highly improved HOMA-IR (p < 0.05).ConclusionNewly diagnosed T2DM Chinese patients with lower baseline HDL-c and higher HbA1c and SBP values are more likely to achieve improvement in beta cell function whereas baseline fasting blood glucose and waist circumference were the significant factors associated with improvement in insulin resistance with acarbose therapy.Trial RegistrationThe clinical trial registry number was ChiCTR-TRC-08000231.

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“…However, the efficacy of acarbose in reducing 2-h postprandial glucose was greater than that of metformin. Similar results were reported by Rosenstock et al [ 15 ] and Wu et al [ 16 ].…”

Section: Discussionsupporting

confidence: 91%

Factors That Influence Pancreatic Beta Cell Function and Insulin Resistance in Newly Diagnosed Type 2 Diabetes Patients: A Sub-Analysis of the MARCH Trial

Duan

Liu

et al. 2018

Diabetes Ther

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“…Indeed, no systemic side effects of acarbose have been reported in the clinical studies performed to date. Specifically, there were no significant changes in complete blood counts, urine analysis, and blood chemistry values over time 37. Acarbose was well tolerated irrespective of patient age, pre-treatment, or the number of concomitant diseases.…”

Section: Safety and Tolerabilitymentioning

confidence: 84%

“…Although there is no direct evidence that acarbose could reduce the risk of CVD in Chinese T2DM patients, it could effectively reduce many CVD risk factors in this patient population, including postprandial hyperglycemia, MAGE, HbA 1c , lipid parameters, and bodyweight 27–32,37–43…”

Section: Therapeutic Efficacymentioning

confidence: 99%

“…In a multicenter, randomized, double-blinded study performed in the People’s Republic of China, patients with insufficiently controlled blood glucose who received a fixed dose of sulfonylureas for 4 weeks before the study exhibited significantly reduced HbA 1c and blood glucose levels after 12 weeks of add-on treatment with acarbose 50 mg tid 37. An additional study of acarbose in Asian patients with T2DM that was inadequately controlled by diet and sulfonylureas revealed that treatment with acarbose 100 mg tid for 24 weeks was associated with significantly greater reductions in HbA 1c (0.9% vs 0.13%, P =0.0018) and 1-hour postprandial blood glucose levels (2.84 mmol/L vs 0.28 mmol/L, P =0.002) compared with placebo 38.…”

Section: Therapeutic Efficacymentioning

confidence: 99%

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Safety and efficacy of acarbose in the treatment of diabetes in Chinese patients

He¹,

Shi²,

Mao³

2014

TCRM

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Acarbose is an α-glucosidase inhibitor that is commonly used to control postprandial blood glucose. It functions as a competitive and reversible inhibitor of small intestinal brush border glucosidase, blocks the degradation of starch and sucrose, and delays the absorption of glucose and fructose in the alimentary tract. The starch content of a diet might alter the hypoglycemic effects of acarbose because of its mechanism of action. Chinese individuals consume a typical Eastern diet, which is characterized by a high intake of whole grains, legumes, vegetables, fruits, and fish. These dietary habits allow acarbose to be used extensively in the People’s Republic of China. Several Chinese-based studies have demonstrated that the use of acarbose as a monotherapy had similar effects on other anti-diabetes agents in decreasing glycosylated hemoglobin (HbA1c) and blood glucose levels, and acarbose in combination with other anti-diabetic drugs could further reduce blood glucose and decrease the mean amplitude of glycemic excursions. Importantly, acarbose is safe and well tolerated, with a low incidence of adverse effects. This article provides a comprehensive review of the safety and efficacy of acarbose for the treatment of diabetes in Chinese patients.

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“…Bioequivalence of these two forms was reported based on the pharmacodynamic (PD) parameters of patients who received the same doses but different brands of either acarbose tablets or chewable tablets. 10 Nevertheless, different administration methods of the same preparation may also have different effects on drug efficacy. For acarbose tablet (Glucobay ® , 50 mg, Bayer), the instruction supports two modes of administration, either direct swallowing or chewing, and in either case they should be administered immediately before or along with the first bite of food.…”

Section: What Is K Nown and Objec Tivementioning

confidence: 99%

Pharmacodynamic comparison of acarbose tablets in Chinese healthy volunteers under chewing and swallowing conditions

Yang

Zhang

et al. 2021

J Clin Pharm Ther

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What is known and objective: Acarbose can efficiently block glucose absorption in the intestine as an alpha-glucosidase inhibitor. It is currently manufactured in several oral dosage forms, with the most common types being tablets and chewable tablets. The acarbose tablet (Glucobay ® , 50 mg, Bayer) package insert gives instructions for either directly swallowing or chewing then swallowing. This study compared the pharmacodynamic effects of a single formulation of acarbose tablets under these two different administration routes.Methods: This randomized, crossover study enrolled 24 healthy subjects who were instructed to chew (C group) or swallow (S group) the acarbose tablet. Glucose levels were monitored in subjects for up to 4 h following administration of 75 g of sucrose to establish a baseline firstly, after which subjects in the C and S groups were administered 50-or 100-mg of acarbose along with 75 g of sucrose. Then, subjects entered a 1-week washout period before being crossed over to the alternate dosing route.Results and discussion: Compared with the S group, the C group had a lower maximum concentration of serum glucose (C max ) and areas under the concentration-time curve (AUC 0-2 , AUC 0-1.5 ). In addition, the maximum reduction in serum glucose (ΔC max ) and the reduction in the AUC (AUEC 0-1.5 ) were both increased in the S group. This occurred at both the 50 mg and 100 mg dosages. These results indicate that fluctuations in blood glucose were lower following chewing of the acarbose tablet. Both administration routes exhibited similar safety and tolerance profiles. What is new and conclusion:In summary, chewing acarbose tablets appears to induce a superior glycaemic-controlling effect compared with swallowing them directly, at least with a single dose. It will be important to inform both clinicians and patients about these differences between the two administrations so that informed clinical decisions can be made, as numerous patients with diabetes are inclined to directly swallow acarbose tablets for convenience.

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Efficacy and safety of acarbose chewable tablet in patients with type 2 diabetes: a multicentre, randomized, double‐blinded, double‐dummy positive controlled trial

Abstract: In summary, acarbose chewable tablets have a definite curative effect in treating type 2 diabetic patients as HbA1c and blood glucose levels decreased significantly after the 12-week treatment.

Cited by 5 publications

References 10 publications

Factors That Influence Pancreatic Beta Cell Function and Insulin Resistance in Newly Diagnosed Type 2 Diabetes Patients: A Sub-Analysis of the MARCH Trial

Factors That Influence Pancreatic Beta Cell Function and Insulin Resistance in Newly Diagnosed Type 2 Diabetes Patients: A Sub-Analysis of the MARCH Trial

Safety and efficacy of acarbose in the treatment of diabetes in Chinese patients

Pharmacodynamic comparison of acarbose tablets in Chinese healthy volunteers under chewing and swallowing conditions

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