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We analyzed data from a randomized clinical trial to evaluate the relationship between changes in adiponectin to changes in lipoprotein risk factors after an intervention that alters adiponectin levels.
A simple, rapid, and precise RP-HPLC method for simultaneous analysis of atorvastatin calcium, metformin hydrochloride, and glimepiride in bulk and its pharmaceutical formulations has been developed and validated. These drugs were separated by using Grace Smart Altima C-8 column (250 × 4.6 mm, 5-μm) with a mobile phase consisting of acetonitrile : phosphate buffer (60 : 40 (v/v), pH 3.0) at a flow rate of 1 mL/min, injection volume 25 µL, and detection at 235 nm. Metformin, atorvastatin, and glimepiride were eluted with retention times of 2.57 min, 7.06 min, and 9.39 min, respectively. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH (Q2B) guidelines. The results of all the validation parameters were found to be within the acceptable limits. The calibration plots were linear over the concentration ranges from 10 to 150 µg/mL, 20 to 200 µg/mL, and 10 to 150 µg/mL for atorvastatin, metformin, and glimepiride, respectively. The accuracy and precision were found to be between 98.2%-105% and ≤2% for three drugs. Developed method was successfully applied for the determination of the drugs in tablet dosage form and recovery was found to be >98% for three drugs. The degradation products produced as a result of stress studies did not interfere with drug peaks.
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In this study in patients with DM-2 and the metabolic syndrome, long-term (12-month) combination treatment with R + M, but not G + M, was associated with a significant improvement in blood pressure control. Improvements in glycemic control and insulin resistance-related parameters were found at 9 months with R + M, compared with 12 months with G + M. Both treatments were well tolerated.
Whether a sulfonylurea may be used together with insulin for treating NIDDM has been controversial. One view, based on older studies, has been that the additional benefit is too small or the level of glucose control achieved usually too poor to recommend this method. More recent studies of a more specific way of combining a sulfonylurea with insulin are more supportive. When a single injection of insulin taken in the evening is added to a sulfonylurea at the time of secondary failure of the sulfonylurea alone, glycemic control is quite simply and consistently restored to acceptable levels. At this time in the natural history of NIDDM, evening insulin combined therapy is more effective than a single injection of insulin alone, and just as effective as a more complex multiple-injection regimen without an oral agent. A recent multicenter trial of a new sulfonylurea, glimepiride, in combination with a single injection of 70/30 insulin before dinner has confirmed that this approach is safe and more consistently effective than insulin alone for obese patients beginning insulin in a setting resembling clinical practice. The available evidence suggests this form of combined therapy is suitable for routine use.
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TZD, but not glimepiride, was an effective and well tolerated third-line therapy in patients without glycaemic control after long-term therapy with metformin + exenatide twice daily. Exenatide twice daily was an effective and well tolerated third-line therapy in patients inadequately controlled on metformin + glimepiride.
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Both neutrophil adhesion and ICAM-1 expression enhanced by high insulin (100 microU/ml, 48 h) were attenuated by gliclazide (20 microM), but not by other K(ATP) channel blockers (glibenclamide, nateglinide, and glimepiride). In addition, both neutrophil adhesion and ICAM-1 expression which were increased by a MAP kinase activator, anisomycin (1 microM), or a PKC activator, phorbol 12-myristate 13-acetate (10 nM) were also attenuated by gliclazide. Nitric oxide (NO) synthase inhibitors did not affect these effects of gliclazide.
This study evaluated the efficacy and tolerability of glimepiride in patients with type 2 diabetes mellitus that was inadequately controlled with a combination of immediate- or extended-release metformin and a thiazolidinedione.
Linearity of enzyme reactions in microsomal incubations was assessed by monitoring the effect of incubation time (from 5 to 60 min) and HLM concentration (from 0.2 to 0.75 mg/ml) on metabolite formation of GLM. The ideal conditions for turnover of GLM were justified using 3x3 factorial design. F value was calculated to confirm the omission of insignificant terms from the full-model to derive a reduced- model polynomial equation. The regression equation was used to develop a contour plot that showed turnover rate within the limits of this design. The optimized reaction velocity data was extrapolated to carry out the kinetic studies in vitro to generate a saturation curve for the determination of Km and Vmax values.
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Total mortality was lower for gliclazide and glimepiride, vs. glibenclamide cohort: HRs 0.33 (95% CI 0.26-0.41), p<0.001 and 0.605 (95% CI 0.413-0.886), p<0.01 respectively. CVD mortality risk reduction vs. glibenclamide was significant only in gliclazide cohort: 0.29 (95% CI 0.21-0.38), p<0.001. Glibenclamide prescriptions had changed from 64.0% (95% CI 63.5-64.5) to 59.5% (95% CI 9.7-10.4). Age at the time of death for OAD-treated patients increased by 6.27 (95% CI 3.67-8.87)yrs, p<0.001.
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We conducted six independent studies to investigate potential drug-drug interactions between 5 mg luseogliflozin and the following OADs usually used in Japan: 1 mg glimepiride, 250 mg metformin, 30 mg pioglitazone, 50 mg sitagliptin, 50 mg miglitol, or 0.6 mg voglibose (0.2 mg before each meal). Twelve subjects were enrolled in each study. The glimepiride, metformin, sitagliptin, and miglitol studies were randomized, open-label, single-dose, three-way crossover studies. The pioglitazone and voglibose studies were open-label studies, where a single dose of luseogliflozin was added to multiple doses of pioglitazone or voglibose. The endpoints were the area under the curve from 0 to 24 h (AUC0-24 h) or to infinity (AUCinf) and the maximum concentration (Cmax) of each drug administered alone or in combination.
Current approaches to pharmacotherapy of type 2 diabetes focus on two key aspects of hyperglycaemia - insulin secretory dysfunction and insulin resistance. Combining drugs that target both these defects via different mechanisms of action improves long-term glycaemic control and offers a number of additional benefits. A fixed-dose combination of pioglitazone and glimepiride in a single tablet is now available in the US (Duetact(TM)). Both pioglitazone and glimepiride are glucose-lowering agents with distinct mechanisms of action. Pioglitazone is a potent and selective peroxisome proliferator-activated receptor-gamma agonist that improves whole-body insulin sensitivity and augments hepatic glucose uptake. On the other hand, glimepiride acts by releasing insulin from pancreatic beta-cells and improves both first and second phases of insulin secretion. These two therapies have been shown to act synergistically to treat type 2 diabetes - glimepiride therapy achieves rapid reductions in glycated haemaglobin (HbA(1c)), whereas pioglitazone sustains glycaemic control in the longer term. Furthermore, pioglitazone and glimepiride affect a number of pleiotropic markers. In particular, pioglitazone has beneficial effects on the atherogenic diabetic dyslipidaemia that are greater than those seen with rosiglitazone and other oral glucose-lowering agents. This advantage is also seen when comparing pioglitazone and rosiglitazone in combination with glimepiride. In addition, pioglitazone also improves a number of atherosclerotic risk markers that appear to translate into clinical benefits on macrovascular outcomes. Glimepiride may also improve several atherosclerotic risk markers and lipoproteins. This review discusses the potential benefits of combining pioglitazone plus glimepiride on patient compliance, targeting the dual effects of insulin resistance and beta-cell dysfunction and affecting a number of metabolic and cardiovascular parameters.
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Treatment with liraglutide 1.2 and 1.8 mg resulted, respectively, in mean increases in quality-adjusted life expectancy of 0.32 ± 0.15 and 0.28 ± 0.14 quality-adjusted life years vs. glimepiride, and 0.19 ± 0.15 and 0.31 ± 0.15 quality-adjusted life years vs. sitagliptin, and was associated with higher costs of £ 3003 ± £ 678 and £ 4688 ± £ 639 vs. glimepiride, and £ 1842 ± £ 751 and £ 3224 ± £ 683 vs. sitagliptin, over a patient's lifetime. Both liraglutide doses were cost-effective, with incremental cost-effectiveness ratios of £ 9449 and £ 16,501 per quality-adjusted life year gained vs. glimepiride, and £ 9851 and £ 10,465 per quality-adjusted life year gained vs. sitagliptin, respectively.
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Glimepiride resulted in a 2.4-mmol/l decrease in fasting plasma glucose (P = 0.04) that was correlated with reductions in postabsorptive endogenous glucose production (EGP) (16.4 +/- 0.6 vs. 13.5 +/- 0.5 micro mol. kg(-1). min(-1), P = 0.01) (r = 0.21, P = 0.01). Postabsorptive EGP on glimepiride was similar to that of control subjects (12.8 +/- 0.9 micro mol. kg(-1). min(-1), NS). Fasting plasma insulin (66 +/- 18 vs. 84 +/- 48 pmol/l, P = 0.05), and first-phase (19 +/- 8 vs. 32 +/- 11 pmol/l, P = 0.04) and second-phase incremental insulin responses to glucose (48 +/- 23 vs. 72 +/- 32 pmol/l, P = 0.02) improved with glimepiride therapy. Insulin sensitivity did not change with treatment (4.6 +/- 0.7 vs. 4.3 +/- 0.7 micro mol. kg(-1). min(-1). pmol(-1)) and remained below that of control subjects (8.1 +/- 1.8 micro mol. kg(-1). min(-1). pmol(-1), P = 0.04).
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One hundred and twenty-nine patients, aged 35-50 years, were enrolled between June 2005 and June 2009. For initial correction of hyperglycaemia, patients with fasting plasma glucose ≥9.0 mmol/L and HbA(1c) ≥ 9.0%, were randomly assigned to therapy with oral drugs + insulin or oral drugs alone. Treatment was stopped after normoglycaemia was maintained for 3 months. Patients were then followed-up with diet and physical exercise. Blood glucose, HbA(1c) and insulin were measured prior to treatment and at 1-year follow-up.
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In quarters with glipizide/glimepiride use, hospital admissions or emergency department visits for hypoglycemia were more common in person quarters with concurrent warfarin use compared with quarters without warfarin use (294/416,479 v 1903/3,938,939; adjusted odds ratio 1.22, 95% confidence interval 1.05 to 1.42). The risk of hypoglycemia associated with concurrent use was higher among people using warfarin for the first time, as well as in those aged 65-74 years. Concurrent use of warfarin and glipizide/glimepiride was also associated with hospital admission or emergency department visit for fall related fractures (3919/416,479 v 20,759/3,938,939; adjusted odds ratio 1.47, 1.41 to 1.54) and altered consciousness/mental status (2490/416,479 v 14,414/3,938,939; adjusted odds ratio 1.22, 1.16 to 1.29). Unmeasured factors could be correlated with both warfarin use and serious hypoglycemic events, leading to confounding. The findings may not generalize beyond the elderly Medicare population.
This study was performed to assess whether the anti-inflammatory and antiatherogenic effects of pioglitazone suggested by animal experiments are reproducible in man and independent from improvements in metabolic control.
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A once-daily dose of liraglutide provides efficacious glycemic control and is not associated with weight gain. Adverse events with the drug are mild and transient, and the risk of hypoglycemia is negligible.
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Data (n = 3,059) were from the aforementioned randomized, double-blind study. Comparisons between vildagliptin (50 mg twice daily) and glimepiride (subgroups of patients on 2 mg/day, 6 mg/day, and 'other', and overall glimepiride group) were done by modeling hypoglycemia risk as a function of time and last-measured glycated hemoglobin (HbA1c) using discrete event time modeling, with treatment, age, gender as additional covariates.
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A multicentre, double-blind, placebo-controlled study randomized patients to receive treatment with vildagliptin 50 mg bid (n = 158) or placebo (n = 160) for 24 weeks.
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The cytochrome P4502C enzymes account for the metabolism of approximately 20% of therapeutic drugs including certain oral antidiabetic drugs (OADs).
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This study provides new insights into therapeutic strategies using sulphonylureas. It shows that gliclazide MR is at least as effective as glimepiride, either as monotherapy or in combination. The safety of gliclazide MR was significantly better, demonstrating approximately 50% fewer confirmed hypoglycaemic episodes in comparison with glimepiride.
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Glimepiride, a sulfonylurea hypoglycemic agent, is metabolized by cytochrome P450 2C9 (CYP2C9) which is known to have genetic polymorphisms. To examine the effects of CYP2C9 genetic polymorphisms on the safety and efficacy of glimepiride in patients with type 2 diabetes, the responses to the glimepiride were measured in Japanese type 2 diabetic patients with the different CYP2C9 genotype. The reduction in the HbA(1c) was significantly larger (P<0.05) among the CYP2C9*1/*3 subjects than among the CYP2C9*1/*1 subjects. The long-term observations of 2 patients with a CYP2C9*1/*3 suggested that subjects with a CYP2C9*1/*3 respond well to glimepiride during the initial phase of treatment, but 1 patient have shown the weight gain over the long-term treatment. The pharmacokinetic study showed that the area under the concentration-time curve for glimepiride in the CYP2C9*1/*3 subjects was approximately 2.5-fold higher than that of the CYP2C9*1/*1 subjects. The intrinsic clearance of glimepiride by the CYP2C9*3 enzyme was lower than that by the CYP2C9*1 enzyme. These results suggested that the lower hydroxylation activity of glimepiride in the subject with type 2 diabetes and CYP2C9*1/*3 led to a marked elevation in the plasma concentrations of glimepiride and a stronger pharmacological effect of glimepiride.