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

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The Synergistic Effect of Miglitol Plus Metformin Combination Therapy in the Treatment of Type 2 Diabetes Clinical Care/Education/Nutrition ORIGINAL ARTICLE The Synergistic Effect of Miglitol Plus Metformin Combination Therapy in the Treatment of Type 2 Diabetes 1 JEAN-LOUIS CHIASSON, MD The recently developed class of 2 LISA NADITCH, MD ␣-glucosidase inhibitors has a unique FOR THE MIGLITOL CANADIAN UNIVERSITY mode of action; it blocks oligosaccharide INVESTIGATOR GROUP catabolism, delays carbohydrate diges- tion and absorption, and smooths and lowers postprandial plasma blood glu- cose peaks (6–9). Substantial evidence supports their use as monotherapy or ad- OBJECTIVE — To investigate the efficacy and safety of miglitol in combination with met- junct therapy for poorly controlled type 2 formin in improving glycemic control in outpatients in whom type 2 diabetes is insufficiently diabetes (5,10–14). Miglitol is the first controlled by diet alone. pseudomonosaccharide ␣-glucosidase in- RESEARCH DESIGN AND METHODS — In this multicenter, double-blind, placebo- hibitor derived from 1-deoxynojirimycin controlled study, 324 patients with type 2 diabetes were randomized, after an 8-week placebo and is structurally a glucose analog run-in period, to treatment with either placebo, miglitol alone, metformin alone, or miglitol plus (15,16). Its efficacy in monotherapy metformin for 36 weeks. The miglitol was titrated to 100 mg three times a day and metformin was (13,17) and in combination with sulfo- administered at 500 mg three times a day. The primary efficacy criterion was change in HbA1c nylureas (11) as a glucose-lowering agent from baseline to the end of treatment. Secondary parameters included changes in fasting and in type 2 diabetes has been shown in a postprandial plasma glucose and insulin levels, serum triglyceride levels, and responder rate. number of clinical studies. A study of miglitol in combination with metformin RESULTS — A total of 318 patients were valid for intent-to-treat analysis. A reduction in mean Ϫ has been reported previously in elderly placebo-subtracted HbA1c of 1.78% was observed with miglitol plus metformin combination therapy, which was significantly different from treatment with metformin alone (Ϫ1.25; P ϭ type 2 diabetic patients (18). However, it 0.002). Miglitol plus metformin also resulted in better metabolic control than metformin alone is still unclear whether miglitol can en- for fasting plasma glucose (Ϫ44.8 vs. Ϫ20.4 mg/dl; P ϭ 0.0025), 2-h postprandial glucose area hance glycemic control when given in under the curve (Ϫ59.0 vs. –18.0 mg/dl; P ϭ 0.0001), and responder rate (70.6 vs. 45.52%; P ϭ combination with metformin in middle- 0.0014). All therapies were well tolerated. aged type 2 diabetic patients and whether the safety and tolerability profile of migli- CONCLUSIONS — In type 2 diabetic patients, miglitol in combination with metformin tol and metformin as monotherapy is af- gives greater glycemic improvement than metformin monotherapy. fected by such a combination. Therefore, this study was performed to investigate Diabetes Care 24:989–994, 2001 the efficacy and safety of miglitol in com- bination with metformin in improving glycemic control, compared with met- aintaining normal plasma glucose in combination. The biguanide met- formin monotherapy, in middle-aged levels is a key factor in reducing formin is a frequent first-line choice of outpatients in whom type 2 diabetes was M the risk of developing diabetes antidiabetic medication (3,4). However, insufficiently controlled by diet alone. complications (1,2). Current recommen- monotherapy with any hypoglycemic The primary control group in this study dations supported by recent data from the agent eventually necessitates the use of in- was the metformin arm. Comparisons U.K. Prospective Diabetes Study data em- creasing doses because type 2 diabetes with miglitol monotherapy and placebo phasize life-style management, diet, and worsens over time with declining pancre- were also performed. exercise as the first-line approach, fol- atic ␤-cell function (5) and eventually re- lowed by therapy with hypoglycemic or quires addition of a second antidiabetic RESEARCH DESIGN AND antihyperglycemic agents, either alone or medication. METHODS — This was a multicenter, ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● double-blind, randomized, placebo- From the 1Research Group on Diabetes and Metabolic Regulation, Research Center, Centre Hospitalier de 2 controlled parallel group study. Eligible l’Universite´ de Montre´al, Montreal, Quebec, Canada; and Sanofi-Synthelabo, Paris, France. patients were type 2 diabetic patients Address correspondence and reprint requests to Jean-Louis Chiasson, MD, Research Group on Diabetes Ͼ and Metabolic Regulation, Research Center CHUM, Hoˆtel-Dieu CHUM, 3850 St. Urbain, 8–202, Montreal, (men and women) 40 years of age Quebec, Canada H2W 1T8. E-mail: [email protected]. in whom diabetes was inadequately Received for publication 28 November 2000 and accepted in revised form 6 February 2001. controlled by diet alone, i.e., in whom L.N. is an employee of Sanofi-Synthelabo, which is involved in the marketing of the product miglitol for HbA level was Ն7.2 and Յ9.5%. The the treatment of type 2 diabetes. 1c Abbreviations: AUC, area under the curve; ITT, intent to treat. major exclusion criteria included type 1 A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion diabetes, the presence of major debili- factors for many substances. tating diseases, recent cardiovascular DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001 989 Miglitol plus metformin in type 2 diabetes events, gastrointestinal diseases, medica- tions were given with the tolerance test tory, vital signs, and concomitant medi- tions likely to affect intestinal motility or meal. The proportion of responders in the cations. The primary efficacy parameter the absorption of nutrients, hypersensi- different treatment groups was also eval- was the change in HbA1c from baseline to tivity to miglitol or metformin, and a his- uated, in which a clinically significant re- the end of treatment and was analyzed by tory of lactic acidosis. Patients who were sponse was defined as either a Ն15% analysis of variance techniques. All four taking either sulfonylurea or metformin reduction in HbA1c from baseline or an treatment groups were included in the Ͻ below the maximum dose could be eligi- HbA1c level 7.0%. primary comparisons, which used or- ble as long as the antidiabetic drug was HbA1c was measured during screen- thogonal contrasts. discontinued. Before starting any study ing, at week –2 and baseline, and there- The primary analysis of efficacy was procedures, patients who fulfilled the el- after at each visit (weeks 4, 8, 12, 16, performed on the ITT population, which igibility criteria gave their written in- 20, 28, and 36) after randomization. Rou- included all patients who had both base- formed consent and entered a single- tine fasting plasma glucose was mea- line and postrandomization efficacy val- blind, 8-week placebo run-in period. All sured at week Ϫ2 and at every subsequent ues. For end-of-treatment analysis, the subjects were seen by a dietitian before visit. Fasting and postprandial (60, 90, last-observation-carried-forward method the run-in period and were advised re- and 120 min) glucose and insulin lev- was used. All patients who received at garding a well-balanced weight-reducing els as well as triglyceride levels were least one dose of trial medication were in- diet (19). They were also advised regard- specifically measured at baseline and at cluded in the safety analysis. Adverse ing exercise, mainly walking 20–30 min weeks 12, 16, and 36 or at premature events and other safety parameters were at least three times per week. The diet was termination. analyzed in terms of the percentage of pa- reinforced after 1 month, and if the HbA1c Safety and tolerability were investi- tients in whom they occurred. was still Ն7.2% by 2 months, they were gated by the occurrence of adverse events; considered dietary failure. Patients with hypoglycemic events; changes in vital RESULTS — A total of 324 patients Ն Յ HbA1c levels 7.2 but 9.5% (110– signs; and changes in laboratory values, were randomized in the study: 83 to pla- 146% above the upper limit of the normal including biochemical parameters, hema- cebo, 82 to miglitol monotherapy, 83 to range) at the end of the run-in period tology, vitamins (thiamine-dependent metformin monotherapy, and 76 to met- were eligible for randomization to match- transketolase, folate, vitamin B12, vitamin formin/miglitol combination therapy. Six ing placebo or to active treatment with A, and retinol protein binding), and stan- patients (one each from the placebo and either miglitol plus placebo, metformin dard urinalysis. Adverse events were metformin/miglitol combination therapy plus placebo, or metformin plus miglitol monitored and documented at week –2 groups and two each from the miglitol for 36 weeks. The miglitol dosage was and at all visits thereafter. Routine bio- and metformin monotherapy groups) force-titrated as follows: administration chemistry, hematology, and urinalysis were excluded from the ITT analysis be- of the drug was started at 25 mg three were performed at screening, baseline, cause of the absence of recorded HbA1c times a day for 4 weeks, increased to 50 and weeks 12, 20, and 36 or at premature values after randomization. A total of 318 mg three times a day for 8 weeks, and termination; vitamin assays were per- patients (98%) were valid for the ITT then increased to 100 mg three times a formed at baseline and at the final visit. analysis. Selected demographic parame- day until the end of the study. Adminis- Physical examinations were conducted at ters and clinical data for all randomized tration of metformin was started and screening, week –2, baseline, week 12, patients are shown in Table 1. Treatment maintained at 500 mg three times a day and the end of the study, whereas vi- groups were comparable for number of throughout the study.
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