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We performed a randomized crossover open comparative study to evaluate the efficacy and safety of voglibose and acarbose in 30 patients with type 2 diabetes who were not well controlled with diet therapy. There was no significant reduction of FBG with either voglibose or acarbose at 4 and 8 weeks after treatment. The 1 h postprandial blood glucose (PPBG) level was significantly decreased from 224.9+/-42.8 to 204.1+/-37.6 (P=0.005) and 206.1+/-38.9 mg/dl (P=0.038) after voglibose therapy at 4 and 8 weeks, respectively. Significant decrease was also obtained after acarbose treatment from 228.3+/-37.4 to 182.7+/-35.5 (P<0.001) and 186.6+/-36.1 mg/dl (P<0.001). The decrease of 1 h PPBG was associated with a significant fall of serum insulin concentration. HbA(1c) levels were also significantly decreased from 7.07+/-1.21 to 6.83+/-1.11 (P=0.017) and 6.79+/-1.33% (P=0.036) after voglibose and 6.98+/-0.98 to 6.70+/-1.04 (P<0.001) and 6.59+/-1.04% (P<0.001) after acarbose at 4 and 8 weeks. In contrast to voglibose, treatment with acarbose significantly decreased the 2 h PPBG at 4 and 8 weeks and the 2 h postprandial serum insulin concentration at 8 weeks. Adverse drug events were more commonly reported in acarbose-treated patients (P<0.05). Increased flatulence was observed in 56.7 and 90% of the patients taking voglibose and acarbose, respectively, while abdominal distention was noted in 10 and 16.7%. Significantly decreased body weights of 0.9 and 0.8 kg were recorded at 8 weeks after voglibose and acarbose therapy, respectively. We conclude that both voglibose (0.2 mg) and acarbose (100 mg) thrice daily significantly decreased HbA(1c), PPBG and postprandial insulin levels. At these dose levels, voglibose was associated with less gastrointestinal side effects and slightly less efficacy for postprandial glucose reduction.
Diabetes Res Clin Pract 2002 Feb
PMID:Efficacy and safety of voglibose in comparison with acarbose in type 2 diabetic patients. 1179 75

Diabetes mellitus has been treated orally with herbal remedies based on folk medicine since ancient times. Embelia ribes burm (Myrsinaceae), known commonly as vidanga, was used in Ayurveda for its anthelmintic activity. Ayurveda describes vidanga as pungent, causes increase in digestive fire, and cures flatulence and colic. A single study reported the antihyperglycemic activity of decoction of E. ribes in glucose-induced hyperglycemic albino rabbits. In the present study, the lipid-lowering and antioxidant potential of ethanolic extract of E. ribes burm was investigated in streptozotocin (40 mg/kg, IV, single injection)-induced diabetes in rats. Twenty days of orally feeding the extract (200 mg/kg) to diabetic rats resulted in significant (P < 0.01) decrease in blood glucose, serum total cholesterol, and triglycerides, and increase in HDL-cholesterol levels when compared to pathogenic diabetic rats. Further, the extract also lowered the liver and pancreas thiobarbituric acid-reactive substances (TBARSs) values (P < 0.01) when compared to TBARS values of liver and pancreas of pathogenic diabetic rats. The results of test drug were comparable to gliclazide (25 mg/kg, orally), a standard antihyperglycemic agent. This is the first pilot study to provide biochemical evidence of potential of E. ribes in diabetic dyslipidemia.
Int J Exp Diabetes Res
PMID:Effect of ethanolic extract of Embelia ribes on dyslipidemia in diabetic rats. 1245 56

The purpose of the study was to determine the efficacy and tolerability of acarbose in Asian type 2 diabetic patients insufficiently controlled by insulin. Asian type 2 diabetic patients on stable insulin dosages were enrolled into a multinational, double-blind, placebo-controlled parallel arm study. After a 2-week screening phase, patients were randomly assigned to 50 mg acarbose t.i.d. or matching placebo for 6 weeks, followed by 100 mg acarbose t.i.d. or placebo for 12 weeks. The primary efficacy parameter was change from baseline in HbA(1c); secondary variables included the changes in fasting and postprandial blood glucose. After 18 weeks of treatment there was a difference in HbA(1c) levels between the two treatment groups (-0.69%, 95% CI (-1.18; -0.2), P=0.008) in favour of acarbose. Reductions in 1-h postprandial glucose levels from baseline to endpoint were observed with acarbose treatment (P=0.029). There were no differences in fasting blood glucose, total triglyceride and cholesterol between the two groups. Safety profiles were similar for both treatment arms except for the higher incidence of flatulence in the acarbose group (28.6% vs. 16.4% for placebo). Adjunctive acarbose therapy offers an efficacious and safe means for improvement of glycemic control in Asian type 2 diabetic patients insufficiently controlled by insulin.
Diabetes Res Clin Pract 2003 May
PMID:Acarbose improves glycemic control in insulin-treated Asian type 2 diabetic patients: results from a multinational, placebo-controlled study. 1270 19

Orlistat, a potent gastrointestinal lipase inhibitor, is a member of a new class of drugs designed for the long-term treatment of obesity. When given with a fat-containing meal, orlistat reduces dietary fat absorption by approximately 30%, which equates to a decrease in caloric absorption of approximately 200 kilocalories per day. A 2-year European study found a mean decrease in body weight of 10.2% (10.3 kg) in the orlistat group compared to 6.1% (6.1 kg) in the placebo group at 1 year. Additionally, 9.3% of the orlistat group versus 2.1% of the placebo group lost >20% of their initial weight. Serum lipids and diabetes control are also improved by orlistat. Related to orlistat's mechanism of action, side effects include oily spotting, flatulence and frequent loose stools, but not frank diarrhea or intestinal malabsorption. Vitamin D and beta-carotene levels decreased, but remained within the normal range. In summary, orlistat is the first example of a new class of antiobesity drugs that enhances weight loss and weight maintenance by interfering with dietary fat absorption. Orlistat has tolerable gastrointestinal side effects and no major drug toxicity. Orlistat is a viable adjunct to lifestyle interventions used in the long-term management of obesity.
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PMID:Orlistat for the long-term treatment of obesity. 1297 16

Celiac disease (CD) is characterized by malabsorption of nutrients in the small intestine. The availability of highly specific and sensitive serologic tests has facilitated its diagnosis, increasing the disease prevalence. The aim of this study was to determine the clinical, laboratory, and histopathological features of CD in Turkish adults. Between 1968 and 2002, CD patients presenting to the Gastroenterology Unit were evaluated retrospectively. From 2002, newly diagnosed patients were prospectively followed up. Sixty patients (39 female, 21 male) were included in the study. Mean body mass index was 22.2 +/- 5.4 kg/m2. The most common symptoms were diarrhea, weight loss, and flatulence. Most common comorbidities were anemia, osteoporosis, type 1 diabetes mellitus, and steatohepatitis. Six (10.0%) patients had a family history of diabetes mellitus; one (1.7%) patient had a family history of CD. Plasma glucose and serum gamma-glutamyltransferase levels were significantly higher in females than males. Most common histopathological findings were increased lymphocytes in the lamina propria (76.2%) and villus epithelium (59.5%). Over the years, the cumulative frequency of CD increased more in females than males. This is the first study in the literature showing the characteristics of CD in Turkish adults. In our previous recent study, the prevalence of tissue transglutaminase antibody positivity in Turkish healthy blood donors was 1.3%, indicating a high prevalence of CD in our population. In this study, the cumulative frequency of CD increased more in females than males. With the better understanding and increased suspicion of the disease, more patients are being diagnosed in our population.
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PMID:Celiac disease in the Turkish population. 1571 51

To assess the satiety-promoting effect of a novel viscous fiber-containing nutrition bar, overweight and obese adult subjects with type 2 diabetes (n=99) were randomized into a double blind, crossover study. They were fed a 300kcal lunch consisting of viscous fiber-containing nutrition bars (VF) or commercial nutrition control bars designed for people with diabetes (CH). VF resulted in a 27.1% increase in fullness (p<0.05), a 15.8% decrease in prospective consumption (p<0.001), and a 14.2% decrease in hunger (p<0.001) in the 120-240min post-lunch areas under the curve (AUC) compared to CH, but no differences were observed for nausea or thirst (p>0.05). Similar results were noted for 0-300min AUC values. VF were associated with greater frequencies and intensities of abdominal distention (p<0.001) and flatulence (p<0.001), and greater frequency of stools (p<0.001) compared to CH, but there were no differences in mean or maximum (loosest) stool consistency (p>0.05). Overall, these results suggest that VF could be a useful tool in weight management of type 2 diabetes.
Diabetes Res Clin Pract 2007 Jun
PMID:Effect of a viscous fiber-containing nutrition bar on satiety of patients with type 2 diabetes. 1702 88

Although most commonly used drugs such as biguanides, sulfonylureas, and more recently, thiazolidinediones, are effective in controlling fasting hyperglycemia, a high percentage of patients have sustained elevated hemoglobin A(1c) because of persistent elevation of postprandial plasma glucose (PPPG). alpha-Glucosidase inhibitors (AGIs) specifically target PPPG. AGIs have been shown in several randomized controlled trials to be effective in controlling blood glucose, whether they are used as monotherapy or in combination with other antidiabetic medications. Among the AGIs, acarbose has also been shown to decrease the risk of progressing to diabetes in subjects with impaired glucose tolerance (IGT). Studies have also suggested that acarbose could decrease the risk of cardiovascular disease, both in IGT and in diabetes. Furthermore, AGIs are very safe and are nontoxic drugs. Their only side effects are gastrointestinal, such as flatulence and diarrhea; however, these can be minimized by the "start low, go slow" approach. AGIs should be considered whenever postprandial hyperglycemia is the dominant metabolic abnormality.
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PMID:Who should benefit from the use of alpha-glucosidase inhibitors? 1817 65

Vinegar (VIN) ingestion at mealtime reduces postprandial glycemia and may benefit individuals with diabetes; hence, the medicinal use of VIN has increased in recent years. This study examined the safety and tolerance of medicinally ingested VIN in type 2 diabetics. Participants (n = 27) were stratified by gender, age, and body mass and randomized into three groups: commercial VIN pills (the reference treatment [REF] (30 mg of acetic acid daily), pickles (PCK) (approximately 1,400 mg of acetic acid daily), or VIN (2,800 mg of acetic acid daily). Participants continued their normal eating habits during the 12-week trial. At baseline and weeks 6 and 12, fasting blood and urine samples were collected, and adverse changes in bowel movements, frequency of burping or flatulence, and episodes of acid reflux were recorded. Reporting frequency for adverse events did not vary significantly by group during the trial; however, 50-56% of PCK and VIN participants reported at least one treatment-emergent adverse event at week 6 as compared to 11% of REF participants (P = .110). Urinary pH was significantly reduced in VIN participants at week 12 as compared to the other groups (-9% vs. +3% and +2% for the PCK and REF groups, respectively, P = .023). At week 6 there was a tendency for aspartate aminotransferase concentrations to increase in the VIN group as compared to the other groups (+17% vs. +8% and -8% for VIN, PCK, and REF, respectively; P = .090). These data indicate that chronic VIN ingestion may influence hepatic function and metabolic pathways aside from glucose metabolism.
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PMID:A preliminary evaluation of the safety and tolerance of medicinally ingested vinegar in individuals with type 2 diabetes. 1836 54

A 69-year-old man was diagnosed as having myasthenia gravis (MG) in September 2004, and treated with thymectomy and prednisolone. He was then diagnosed as having steroid-induced diabetes mellitus, and received sulfonylurea (SU) therapy in May 2005. An alpha-glucosidase inhibitor (alphaGI) was added in March 2006, resulting in good glycemic control. He experienced symptoms of abdominal distention, increased flatus, and constipation in October 2007, and was admitted into our hospital in late November with hematochezia. Plain abdominal radiography revealed small linear radiolucent clusters in the wall of the colon. Computed tomography (CT) showed intramural air in the sigmoid colon. Colonoscopy revealed multiple smooth surfaced hemispherical protrusions in the sigmoid colon. The diagnosis of pneumatosis cystoides intestinalis (PCI) was made on the basis of these findings. As the alphaGI voglibose was suspected as the cause of this patient's PCI, treatment was conservative, ceasing voglibose, with fasting and fluid supplementation. The patient progressed well, and was discharged 2 wk later. Recently, several reports of PCI associated with alphaGI therapy have been published, predominantly in Japan where alphaGIs are commonly used. If the use of alphaGIs becomes more widespread, we can expect more reports of this condition on a global scale. The possibility of PCI should be considered in diabetic patients complaining of gastrointestinal symptoms, and the gastrointestinal tract should be thoroughly investigated in these patients.
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PMID:Pneumatosis cystoides intestinalis following alpha-glucosidase inhibitor treatment: a case report and review of the literature. 1893 91

Good compliance with hypoglycemic therapy is important for diabetes treatment, since positive relationship between medication compliance and glycemic control has been reported. To improve medication compliance, the oral disintegrating tablet technology that facilitates drug administration without water has been employed in various drugs, including voglibose, an alpha glucosidase inhibitor. In the present survey, we investigated safety profile of voglibose oral disintegrating tablet (VODT), and whether treatment with VODT results in improvement of medication compliance and glycemic control. Patients with diabetes received VODT 0.6 or 0.9 mg/day for 12 weeks. Among 2,930 eligible patients, adverse drug reactions were observed in 3.6%, with the most common being abdominal distension, flatulence, diarrhea, and increased alanine aminotransferase levels. In 1,067 patients who received conventional voglibose tablet (CVT) prior to VODT, 53.1% reported that taking VODT was easier than taking CVT. Medication compliance was improved after switching to VODT in 28.4% of patients who missed taking tablets more than one time a week during CVT treatment. A significant decrease in HbA(1C) levels was observed in patients whose medication compliance was improved after switching to VODT (P = 0.033), but there was no significant reduction in HbA(1C) levels in patients whose medication compliance did not change. In conclusion, the present survey suggests that the safety profile of VODT is comparable with that of CVT, and switching from CVT to VODT has positive impact on medication compliance which may lead to an improvement in glycemic control.
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PMID:Improvement in medication compliance and glycemic control with voglibose oral disintegrating tablet. 1898 59


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