The Synergistic Effect of Miglitol Plus Metformin Combination Therapy in the Treatment of Type 2 Diabetes

Abstract

OBJECTIVE -To investigate the efficacy and safety of miglitol in combination with metformin in improving glycemic control in outpatients in whom type 2 diabetes is insufficiently controlled by diet alone.RESEARCH DESIGN AND METHODS -In this multicenter, double-blind, placebocontrolled study, 324 patients with type 2 diabetes were randomized, after an 8-week placebo run-in period, to treatment with either placebo, miglitol alone, metformin alone, or miglitol plus metformin for 36 weeks. The miglitol was titrated to 100 mg three times a day and metformin was administered at 500 mg three times a day. The primary efficacy criterion was change in HbA 1c from baseline to the end of treatment. Secondary parameters included changes in fasting and postprandial plasma glucose and insulin levels, serum triglyceride levels, and responder rate.RESULTS -A total of 318 patients were valid for intent-to-treat analysis. A reduction in mean placebo-subtracted HbA 1c of Ϫ1.78% was observed with miglitol plus metformin combination therapy, which was significantly different from treatment with metformin alone (Ϫ1.25; P ϭ 0.002). Miglitol plus metformin also resulted in better metabolic control than metformin alone for fasting plasma glucose (Ϫ44.8 vs. Ϫ20.4 mg/dl; P ϭ 0.0025), 2-h postprandial glucose area under the curve (Ϫ59.0 vs. -18.0 mg/dl; P ϭ 0.0001), and responder rate (70.6 vs. 45.52%; P ϭ 0.0014). All therapies were well tolerated.CONCLUSIONS -In type 2 diabetic patients, miglitol in combination with metformin gives greater glycemic improvement than metformin monotherapy. Diabetes Care 24:989 -994, 2001

Effects of consuming foods containing oat β-glucan on blood pressure, carbohydrate metabolism and biomarkers of oxidative stress in men and women with elevated blood pressure

“…a-Glucosidase inhibitors, such as acarbose and miglitol, slow the absorption of glucose by delaying digestion of starches in the small intestine (Chiasson and Naditch, 2001). Like viscous soluble fibers, these compounds reduce postprandial blood glucose and insulin excursions.…”

Metformin therapy and clinical uses

“…20,[46][47][48] A one-year study demonstrated equivalent antihyperglycaemic efficacy with a metformin-sulphonylurea combination compared with a pioglitazone-sulphonylurea combination in patients inadequately controlled on a sulphonylurea alone. 49 The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) study demonstrated a greater reduction of HbA 1C with metformin (n=272) compared with rosiglitazone (n=301), when added to maximal sulphonylurea therapy for 18 months (mean treatment difference 0.06% [95% CI -0.09 to 0.20]).…”

“…[18][19] Metformin has shown greater antihyperglycaemic efficacy than α-glucosidase inhibitors [20][21][22] and DPP-4 inhibitors [23][24] when given as monotherapy.…”

Computational pharmacokinetics and in vitro-in vivo correlation of anti-diabetic synergistic phyto-composite blend

“…glibenclamide [14] . In case of allopathy, results of clinical trials have shown that combination therapy with miglitol and metformin was found to be more effective than the use of single drug alone [15] . Establishment of standard quality control profile in global context to confirm the validity and reproducibility of phytochemical constituents in the form of processed extract rather than single isolated compound; proper analytical and spectroscopic method development for structural characterizations in combined forms; rigorous validation of safety profile and pharmacokinetic parameters is essential to find a scientific basic of phytosynergy which may give rise to a new generation of medicinal products -phyto-pharmaceuticals [11] .…”

“…Medicine in recent times, whether western classical or phyto-therapy, advocates for combination therapy, instead of single approach. Synergy research in phytotherapy, with the aid of "omics technologies" needs a rationale for establishing its pharmacological and therapeutic superiority to treat diseases which have hitherto been treated using synthetic drugs alone [11][12][13][14][15] . Along with the paradigm of translational health research with the perspectives of bench to bedside approach; all pharmaceutical RDs target to develop robust, cost effective, enhanced throughput in vitro assays which may be extrapolated to humans and serve the purpose of bio-waiver.…”