BACKGROUND: Alpha-glucosidase inhibitors or dipeptidyl peptidase-4 inhibitors are both hypoglycemia agents that specifically impact on postprandial hyperglycemia. We compared the effects of acarbose and sitagliptin add on to metformin on time in range (TIR) and glycemic variability (GV) in Chinese patients with type 2 diabetes mellitus through continuous glucose monitoring (CGM). METHODS: This study was a randomized, open-label, active-con-trolled, parallel-group trial conducted at 15 centers in China from January 2020 to August 2022. We recruited patients with type 2 diabetes aged 18-65 years with body mass index (BMI) within 19-40 kg/m 2 and hemoglobin A1c (HbA1c) between 6.5% and 9.0%. Eligible patients were randomized to receive either metformin combined with acarbose 100 mg three times daily or metformin combined with sitagliptin 100 mg once daily for 28 days. After the first 14-day treatment period, patients wore CGM and entered another 14-day treatment period. The primary outcome was the level of TIR after treatment between groups. We also performed time series decomposition, dimensionality reduction, and clustering using the CGM data. RESULTS: A total of 701 participants received either acarbose or sitagliptin treatment in combination with metformin. There was no statistically significant difference in TIR between the two groups. Time below range (TBR) and coefficient of variation (CV) levels in acarbose users were significantly lower than those in sitagliptin users. Median (25th percentile, 75th percentile) of TBR below target level <3.9 mmol/L (TBR 3.9 ): Acarbose: 0.45% (0, 2.13%) vs . Sitagliptin: 0.78% (0, 3.12%), P = 0.042; Median (25th percentile, 75th percentile) of TBR below target level <3.0 mmol/L (TBR 3.0 ): Acarbose: 0 (0, 0.22%) vs . Sitagliptin: 0 (0, 0.63%), P = 0.033; CV: Acarbose: 22.44 ± 5.08% vs . Sitagliptin: 23.96 ± 5.19%, P <0.001. By using time series analysis and clustering, we distinguished three groups of patients with representative metabolism characteristics, especially in GV (group with small wave, moderate wave and big wave). No significant difference was found in the complexity of glucose time series index (CGI) between acarbose users and sitagliptin users. By using time series analysis and clustering, we distinguished three groups of patients with representative metabolism characteristics, especially in GV. CONCLUSIONS: Acarbose had slight advantages over sitagliptin in improving GV and reducing the risk of hypoglycemia. Time series analysis of CGM data may predict GV and the risk of hypoglycemia. TRIAL REGISTRATION Chinese Clinical Trial Registry: ChiCTR2000039424.
Humans ; Metformin/therapeutic use* ; Sitagliptin Phosphate/therapeutic use* ; Acarbose/therapeutic use* ; Diabetes Mellitus, Type 2/blood* ; Middle Aged ; Male ; Female ; Adult ; Blood Glucose/drug effects* ; Hypoglycemic Agents/therapeutic use* ; Aged ; Glycated Hemoglobin/metabolism* ; Adolescent ; Young Adult ; China ; East Asian People

We studied the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetes patients whose blood glucose levels were inadequately controlled with basal insulin alone or in combination with metformin (or a sulfonylurea). This study was a 24-week prospective, open-label, randomized, active-controlled multi-center study. Participants were randomized to receive either acarbose (n=59, 300 mg/day) or voglibose (n=62, 0.9 mg/day). The mean HbA1c at week 24 was significantly decreased approximately 0.7% from baseline in both acarbose (from 8.43% +/- 0.71% to 7.71% +/- 0.93%) and voglibose groups (from 8.38% +/- 0.73% to 7.68% +/- 0.94%). The mean fasting plasma glucose level and self-monitoring of blood glucose data from 1 hr before and after each meal were significantly decreased at week 24 in comparison to baseline in both groups. The levels 1 hr after dinner at week 24 were significantly decreased in the acarbose group (from 233.54 +/- 69.38 to 176.80 +/- 46.63 mg/dL) compared with the voglibose group (from 224.18 +/- 70.07 to 193.01 +/- 55.39 mg/dL). In conclusion, both acarbose and voglibose are efficacious and safe in patients with type 2 diabetes who are inadequately controlled with basal insulin. (ClinicalTrials.gov number, NCT00970528)
Acarbose/adverse effects/*therapeutic use ; Blood Glucose ; Diabetes Mellitus, Type 2/blood/*drug therapy ; Enzyme Inhibitors/adverse effects/therapeutic use ; Female ; Hemoglobin A, Glycosylated/analysis ; Humans ; Hypoglycemic Agents/adverse effects/therapeutic use ; Inositol/adverse effects/*analogs & derivatives/therapeutic use ; Insulin/*blood/therapeutic use ; Male ; Metformin/therapeutic use ; Middle Aged ; Prospective Studies ; alpha-Glucosidases/antagonists & inhibitors

BACKGROUNDGlycemic variability, an HbA1c-independent risk factor, has more deleterious effects than sustained hyperglycemia in the development of diabetic complications. This study analyzed the characteristics of glycemic variability in type 2 diabetes mellitus (T2DM) with HbA1c < 6.5% in duration of twice daily premixed insulin treatment and the effect of further treatment with acarbose.

METHODSEighty-six T2DM patients who used premixed insulin analogue (insulin aspart 30) twice daily and had HbA1c < 6.5% and 20 controlled subjects with normal glucose regulation (NGR) were monitored using the continuous glucose monitoring (CGM) system. The mean amplitude of glycemic excursions (MAGE), mean of daily differences (MODD) were used for assessing intra-day, inter-day glycemic variability. Hypoglycemia was defined as glucose level < 3.9 mmol/L for at least 15 minutes in CGM. According to reference values of MAGE, T2DM patients were classified into two groups: low-MAGE group with MAGE < 3.4 mmol/L (L-MAGE) and high-MAGE group with MAGE ≥ 3.4 mmol/L (H-MAGE). H-MAGE group received further treatment with acarbose for 2 weeks and was monitored a second time with CGM system.

RESULTSAfter first CGM, L-MAGE group had 41 cases, and H-MAGE group had 45 cases. The MAGE and MODD of T2DM group were all higher than those of subjects with NGR (P < 0.01). Twenty-four percent (n = 11) in H-MAGE group had a total of 13 hypoglycemic events, 10 of the 13 events occurred at night, meanwhile 5% (n = 2) in L-MAGE group had a total of 2 hypoglycemic events, which also occurred at night (hypoglycemic events: 24% vs. 5%, χ(2) = 6.40, P < 0.01). MAGE value was correlated with hypoglycemia value and 2-hour postprandial plasma glucose value (r = -0.32 and 0.26, respectively, P < 0.05). After further acarbose therapy and secondly CGM, MAGE and MODD values in H-MAGE group were all significantly decreased (40%, P < 0.01, and 15%, P < 0.05, respectively), but remained higher than in the subjects with NGR (P < 0.05); 2% (n = 1) had a total of 1 hypoglycemic event, incidence significantly decreased (2% vs. 24%, χ(2) = 9.61, P < 0.01).

CONCLUSIONSCGM system can detect the glycemic variability and asymptomatic hypoglycemic events of T2DM with well-controlled HbA1c in duration of insulin treatment. Combination therapy of premixed insulin twice daily with acarbose can flat glycemic variability and decrease hypoglycemic events.

Acarbose ; administration & dosage ; therapeutic use ; Adult ; Diabetes Mellitus, Type 2 ; blood ; drug therapy ; metabolism ; Female ; Glycated Hemoglobin A ; metabolism ; Humans ; Hypoglycemic Agents ; therapeutic use ; Insulin ; administration & dosage ; therapeutic use ; Male ; Middle Aged

BACKGROUNDPostprandial hypotension (PPH) occurs frequently in elderly people and may lead to syncope, falls, dizziness, weakness, angina pectoris, and stroke. Some studies suggest that the magnitude of the postprandial fall in blood pressure (BP) is influenced by the rate at which glucose enters the small intestine. We hypothesized that acarbose (alpha-glucosidase inhibitor), a hypoglycemic agent that decreases the rate of glucose absorption in the small intestine, would attenuate PPH in the elderly, and would be safe in the treatment.

METHODSForty-three elderly in-patients with PPH were recruited. All of them were in relatively stable conditions. They had semi-liquid standard meals without and with acarbose for the two following days: screening day and intervention day. Blood pressure and heart rate (HR) were recorded at baseline and every 15 minutes for 120 minutes using a non-invasive ambulatory blood pressure monitoring system during the study, and ejection fraction (EF) and fractional shortening (FS) were measured by two dimensional echocardiography.

RESULTSCompared with the screening day, the falls in systolic, diastolic and mean arterial blood pressure (SBP, DBP, MAP) (all P < 0.05) were significantly attenuated after taking acarbose during breakfast, so were MAP (P < 0.05) during lunch, DBP (P < 0.05) and MAP (P < 0.05) during supper. The change of HR was not statistically significant after taking acarbose in three meals. EF and FS were positively correlated with the relief rate. The effective power was 63%, and the incidence of adverse drug reaction (ADR) was 9%.

CONCLUSIONAcarbose is effective and safe in the treatment of elderly patients with PPH.

Acarbose ; adverse effects ; therapeutic use ; Aged ; Aged, 80 and over ; Blood Pressure ; drug effects ; Enzyme Inhibitors ; therapeutic use ; Female ; Heart Rate ; drug effects ; Humans ; Hypoglycemic Agents ; therapeutic use ; Hypotension ; drug therapy ; Male ; Postprandial Period ; physiology

OBJECTIVETo observe the effect of Yuquan Pill (YP) on proinflammatory cytokines in patients with type 2 diabetes mellitus (DM2).

METHODSNinety patients with DM2 were randomly divided into the treated group and the control group by the ratio of 2:1. Both groups were treated with Glucobay on the base of dietary and exercise therapy for 3 months, with YP, given to the treated group additionally 6 g four times a day. And the changes of proinflammatory cytokines, including C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6), etc. were observed.

RESULTSThe levels of serum CRP,TNF-alpha and IL-6 significantly lowered after treatment in both groups (P<0.01), and the improvement in the treated group was superior to that in the control group (P<0.01).

CONCLUSIONYP could reduce the levels of the increased proinflammatory cytokines in patients with DM2.

Acarbose ; therapeutic use ; Adult ; Aged ; C-Reactive Protein ; metabolism ; Diabetes Mellitus, Type 2 ; blood ; drug therapy ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Hypoglycemic Agents ; therapeutic use ; Interleukin-6 ; blood ; Male ; Middle Aged ; Phytotherapy ; Tumor Necrosis Factor-alpha ; blood

The alterations in atherogenic index of plasma (AlP) in type 2 diabetic patients and their normoglycemic first-degree relatives (NFDR) were investigated, and the effects of Acarbose or Glimepiride on AIP in 99 type 2 diabetic patients were evaluated. Triglycerride (TG), total cholesterol, high density lipoprotein-cholesterol (HDL-C) levels were analyzed, and Log (TG/HDL-C) was calculated as AIP in 62 type 2 diabetic patients and their 67 NFDR from 29 type 2 diabetic pedigrees and in 45 healthy controls without family histories of diabetes. Also analyzed were the same parameters in 99 type 2 diabetic patients before and after therapy with Acarbose or Glimepiride. The results revealed that diabetic patients and their NFDR had significantly higher AIP than did the controls, whereas no significant differences were seen between diabetic patients and their NFDR. Positive correlation of AIP between type 2 diabetic patients and their offspring were observed (r = 0.241, P < 0.05). After 8 weeks therapy with Acarbose, the AIP of type 2 diabetic patients was decreased significantly, and no differences were observed for AIP levels in Glimepiride group although the AIP was lower when compared with the untreated level. As a significant inverse correlation of small dense low density lipoprotein (sdLDL) with AIP was confirmed, our data suggest that diabetic patients and their NFDR from type 2 diabetic pedigrees had significantly higher AIP than did controls; AIP could be decreased by therapy with Acarbose in type 2 diabetic patients; Glimepiride may bring potential benefit to type 2 diabetic patients by influencing sdLDL.
Acarbose ; therapeutic use ; Atherosclerosis ; blood ; Body Mass Index ; Case-Control Studies ; Cholesterol, HDL ; blood ; Diabetes Mellitus, Type 2 ; blood ; drug therapy ; Humans ; Hypoglycemic Agents ; therapeutic use ; Pedigree ; Sulfonylurea Compounds ; therapeutic use ; Triglycerides ; blood

OBJECTIVETo observe the effect of combination therapy of acarbose and Liuwei Nengxiao capsule (LWNXC) in improving senile postprandial hyperglycemia and insulin sensitivity.

METHODSSeventy-four patients with simple postprandial hyperglycemia were divided into the control group and the treated group, 37 in each group, who were treated with acarbose alone and the combination therapy respectively for 1 month, and the changes on 2 hrs postprandial glucose (2 hPG), blood pressure (BP), blood lipid, body mass index (BMI), insulin functional index as well as the adverse reaction of acarbose in the two groups were observed.

RESULTSAfter treatment, the levels of 2 hPG, fasting blood glucose (FBG), BMI, total cholesterol and lowdensity lipoprotein-cholesterol were improved in the treated groups more significantly than those in the control group (P < 0.05 or P < 0.01). Insulin sensitive index (ISI) and insulin resistance were improved in the two group (P < 0.05 or P < 0.01), but the improvement in the treated group was more significant than that in the control group (P < 0.01). Moreover, the adverse reactions were less in the treated group than in the control group.

CONCLUSIONThe combination therapy of acarbose and LWNXC could not only improve the postprandial hyperglycemia, but also markedly increase the insulin sensitivity, and shows obvious improving effect on parameters of blood lipid, BP and BMI. The adverse reaction could be evidently reduced by combined use with LWNXC.

Acarbose ; therapeutic use ; Aged ; Blood Glucose ; metabolism ; Capsules ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Glycoside Hydrolase Inhibitors ; Humans ; Hyperglycemia ; drug therapy ; Hypoglycemic Agents ; therapeutic use ; Insulin Resistance ; Lipids ; blood ; Male ; Middle Aged ; Phytotherapy ; Postprandial Period

OBJECTIVETo evaluate the cost-effectiveness of preventive treatment on diabetes, using metformin or acarbose among patients with impaired glucose tolerance.

METHODSUsing data from diabetes prevention program (DPP) and STOP-NIDDM study, we evaluated the cost of preventing one new onset of diabetes in Shanghai, and to compare its cost with the current treatment cost.

RESULTSIf metformin was used for preventive treatment as in DPP study, a total cost of 69 122.95RMB was needed for preventing one new onset of diabetes in three years period. If acarbose was used for preventive treatment as in STOP-NIDDM, then 154 116.05RMB was the cost to prevent one diabetes in 3.3 years of treatment. However, if the generic metformin was used, the total cost was only 21 666.63RMB for the 3-years treatment. Data showed that the average cost for treating diabetes per year was 9143.70RMB in Shanghai.

CONCLUSIONThe total cost of diabetes prevention was formidable, although generic metformin showed the trend of cost-effective. The cost of drugs took the biggest part of the total cost. To choose the cheap but effective drug for treatment might save a large part of the cost. Further clinical research concerning the prevention of complications might provide us with more information on the cost-effectiveness of preventive treatment on diabetes.

Acarbose ; therapeutic use ; Attitude to Health ; Cost-Benefit Analysis ; Diabetes Mellitus, Type 2 ; economics ; prevention & control ; Follow-Up Studies ; Glucose Intolerance ; drug therapy ; economics ; Glucose Tolerance Test ; Humans ; Hypoglycemic Agents ; economics ; therapeutic use ; Metformin ; therapeutic use ; Preventive Health Services ; economics ; Risk Reduction Behavior ; Surveys and Questionnaires