Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double‐blind trial

Iwamoto, Yasuhiko; Tajima, Naoko; Kadowaki, Takashi; Nonaka, Kenji; Taniguchi, Tadaaki; Nishii, Mikio; Ferreira, Juan Camilo Arjona; Amatruda, John M.

doi:10.1111/j.1463-1326.2010.01197.x

Cited by 96 publications

(91 citation statements)

References 25 publications

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“…1A). The AUCs of the plasma glucose levels in the M, S and M+S groups were treatment in Japanese patients with type 2 diabetes [16]. Of note, sitagliptin, unlike miglitol, failed to decrease the plasma glucose levels at 30 min after the start of breakfast (Fig.…”

Section: Resultsmentioning

confidence: 91%

Effects of miglitol, sitagliptin or their combination on plasma glucose, insulin and incretin levels in non-diabetic men

et al. 2010

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α-Glucosidase inhibitors (αGIs) decrease plasma glucose and serum insulin levels in healthy subjects [1,2] and reduce the development of type 2 diabetes in subjects with impaired glucose tolerance (IGT) [3,4]. αGIs reportedly enhance active glucagon-like peptide-1 (GLP-1) responses and reduce total glucose-dependent insulinotropic polypeptide (GIP) responses [5][6][7]; however, their significance for protecting against the development of diabetes remains uncertain. Dipeptidyl peptidase-4 (DPP-4) inhibitors, such as sitagliptin, increase active GLP-1 and GIP by inhibiting DPP-4 enzymatic activity and improve hyperglycemia in a glucose-dependent fashion by increasing serum insulin and decreasing serum glucagon levels in diabetic patients [8] abstract. α-glucosidase inhibitors (αGIs) increase active glucagon-like peptide-1 (GLP-1) and reduce the total glucosedependent insulinotropic polypeptide (GIP) levels, but their ability to prevent diabetes remains uncertain. Dipeptidyl peptidase-4 (DPP-4) inhibitors, such as sitagliptin, increase active GLP-1 and GIP levels and improve hyperglycemia in a glucose-dependent fashion. However, the effectiveness of their combination in subjects with normal glucose tolerance (NGT) or impaired glucose tolerance (IGT) is uncertain. The present study evaluated the effect of miglitol, sitagliptin, and their combination on glucose, insulin and incretin levels in non-diabetic men. Miglitol and sitagliptin were administered according to four different intake schedules (C: no drug, M: miglitol; S: sitagliptin, M+S: miglitol and sitagliptin). The plasma glucose levels were significantly lower for M, S and M+S than for the control. The areas under the curve (AUCs) of the plasma active GLP-1 level in the M, S, and M+S groups were significantly greater than that in the control group. The AUC of the plasma active GLP-1 level was significantly greater for M+S group than for the M and S groups. The AUC of the plasma total GIP level was significantly smaller for M+S group than for the control and M and S groups. The results of our study suggest that miglitol, sitagliptin, or their combination contributes to the prevention of type 2 diabetes.

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Section: Resultsmentioning

confidence: 91%

Effects of miglitol, sitagliptin or their combination on plasma glucose, insulin and incretin levels in non-diabetic men

et al. 2010

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“…Low-density lipoprotein cholesterol levels were calculated by the Friedewald equation because all patients had TG levels less than 400 mg/dL [15]. Serum apolipoprotein AI, apolipoprotein AII, ApoB, apolipoprotein CII, apolipoprotein CIII, and apolipoprotein E levels were determined using turbidimetric immunoassays (Apo A-I Auto N "Daiichi," Apo A-II Auto N the total caloric content was approximately 500 kcal, with 75 g carbohydrate and 18.8 g protein [9].…”

Section: Measurementsmentioning

confidence: 99%

“…Simple randomization was performed in order of clinic visits using a random number table. Based on previous reports that showed a 12-week post-interventional decrease of 0.70% in hemoglobin A 1c (HbA 1c ) with sitagliptin [9] and of 0.16% in HbA 1c with miglitol [11], the sample size was estimated to be approximately 15 in each group with a significance level (α) of 5% and detection level (1 − β) of 80% (2-tailed). Eligibility criteria were as follows: age > 20 years, the absence of pregnancy, fasting serum triglyceride (TG) levels < 250 mg/dL, HbA 1c < 9.4%, serum creatinine level < 1.0 mg/dL, and no changes in medications during the 3 months before enrollment in the study.…”

Section: Subjectsmentioning

confidence: 99%

“…Time measurement was started when half of the cookie had been ingested. Sitagliptin and 100 mL water were given 30 min before the CLT as previously reported [9], whereas miglitol and 100 mL water were given immediately before the CLT [19]. Blood samples were obtained during the fasting state before cookie ingestion and at 60 min and 120 min after the cookie load.…”

Section: Cookie-loading Testmentioning

confidence: 99%

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Effects of miglitol <i>versus</i> sitagliptin on postprandial glucose and lipoprotein metabolism in patients with type 2 diabetes mellitus

et al. 2013

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PostPrandial hyPerglycemia and hyperlipidemia have been shown to be risk factors for atherosclerosis [1][2][3]. Potential agents to target postprandial hyperglycemia and hyperlipidemia in patients with type 2 diabetes mellitus (T2DM) include α-glucosidase inhibitors (AGIs) and dipeptidyl peptidase (DPP)-4 inhibitors. Miglitol is an AGI that improves postprandial hyperglycemia and hyperlipidemia [4] abstract. Postprandial hyperglycemia and/or hyperlipidemia can contribute to development of atherosclerosis in patients with type 2 diabetes mellitus (T2DM). The objective of this study was to compare the effects of miglitol and sitagliptin on postprandial glucose and lipid metabolism in patients with T2DM. Thirty-five patients with T2DM were randomized to 2 groups receiving miglitol (150 mg/day) or sitagliptin (50 mg/day). Serum variables related to glucose and lipid metabolism were measured before and after treatment for 10 weeks and at 0, 60, and 120 min using a cookie-loading test (CLT). After 10 weeks of treatment, miglitol (n = 16) and sitagliptin (n = 18) caused a similarly significant decrease in hemoglobin A 1c (mean: 7.6% to 7.3% versus 8.0% to 7.6%) and a significant increase in fasting insulin levels, with a greater increase observed in the miglitol group than in the sitagliptin group (p=0.03). In addition, a significant decrease in the change in glucose levels after the CLT was observed in both groups, with a greater decrease observed in the miglitol group than in the sitagliptin group (p=0.02). The miglitol group also showed a greater decrease in the change in insulin levels after the CLT than the sitagliptin group (p<0.01). The lipid and lipoprotein levels did not show any significant differences between the groups after the CLT. Our results suggested that miglitol and sitagliptin treatment resulted in similar glycemic control but that a greater decrease in postprandial glucose and insulin levels was observed with miglitol compared with sitagliptin in patients with T2DM.

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“…In 2009, the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin was approved as the first incretin enhancer for use in Japan [4][5][6][7][8][9][10][11] . Although it has been suggested that seasonal fluctuations of hemoglobin A1c (HbA1c) are noted in patients with type 2 diabetes, no reports have been published concerning the efficacy of antidiabetic agents for such fluctuations.…”

Section: Introductionmentioning

confidence: 99%

Sitagliptin counteracts seasonal fluctuation of glycemic control

Matsuhashi

Sano²,

Fukuda³

et al. 2012

WJD

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AIM:To assess the effect of sitagliptin therapy on seasonal fluctuation of glycemic control in Japanese type 2 diabetic patients. METHODS:Participating patients (age: 29-80 years) had been treated with conventional oral antidiabetic agents and/or diet and exercise therapy for over 6 mo. From December 2009, 35 patients were additionally prescribed oral sitagliptin starting from 50 mg once daily, while 19 patients taking α-glucosidase inhibitors were switched to sitagliptin. Twenty-four patients who refused sitagliptin formed the control group. Changes of mean monthly hemoglobin A1c (HbA1c) during the "winter holiday season" were compared between groups using Student's t -test (2008-2009 vs 2009-2010). Statistical significance was accepted at � < 0.05. �ulti�ariate 0.05. �ulti�ariate analysis was performed to assess whether sitagliptin use was associated with deterioration or improvement of glycemic control. RESULTS:Both add-on sitagliptin and switching from α-glucosidase inhibitors to sitagliptin prevented the seasonal deterioration of glycemic control and tended to improve HbA1c. Multivariate analysis revealed that both adding and switching to sitagliptin were negatively correlated with deterioration of glycemic control. In 44 patients who continued sitagliptin therapy for another year, elevation of HbA1c was suppressed without adverse effects. CONCLUSION:Sitagliptin is a suitable oral agent for preventing deterioration of glycemic control during the winter holiday season.

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Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double‐blind trial

Cited by 96 publications

References 25 publications

Effects of miglitol, sitagliptin or their combination on plasma glucose, insulin and incretin levels in non-diabetic men

Effects of miglitol, sitagliptin or their combination on plasma glucose, insulin and incretin levels in non-diabetic men

Effects of miglitol <i>versus</i> sitagliptin on postprandial glucose and lipoprotein metabolism in patients with type 2 diabetes mellitus

Sitagliptin counteracts seasonal fluctuation of glycemic control

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