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Compared with glimepiride, dapagliflozin as monotherapy for T2DM is a more cost-effective treatment for T2DM patients on monotherapy in China. The weight control has been identified as the major contributor for the higher cost-effectiveness of dapagliflozin.
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When compared with suboptimally titrated IM there was a trend towards a lower HbA1c with GMP and significantly more GMP subjects obtained an HbA1c under 7%. Global assessments by investigators and subjects showed both a greater efficacy and tolerability with GMP.
We extracted data in duplicate and assessed the methodological quality using the Cochrane risk of bias tool.
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NCT01081834; NCT01106677; NCT01106625; NCT00968812; NCT01137812.
Using 96% ethanol as solvent, a less toxic and cost-effective spectrophotometric method for the determination of glimepiride in solid dosage forms was developed and validated. The results of the validated parameters showed a λ(max) of 231 nm, linearity range of 0.5-22 μg/mL, precision with relative SD of <1.0%, recovery accuracy of 100.8%, regression equation of y = 45.741x + 0.0202, R(2) = 0.999, limit of detection of 0.35 μg/mL, and negligible interference from common excipients and colorants. The method was found to be accurate at the 95% confidence limit compared with the standard liquid chromatographic method with comparable reproducibility when used to assay the formulated products Amaryl(®) (sanofi-aventis, Paris, France) and Mepyril(®) (May & Baker Nigeria PLC, Ikeja, Nigeria). The results obtained for the validated parameters were within allowable limits.
In a subset of diabetic men from the VADT, intensive glucose management did not affect conventional lipids or ADLS, but had some beneficial effects on particle characteristics as defined by NMR and on ApoCIII.
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Hospitalized patients at increased risk for sulfonylurea-related hypoglycemia were those aged 65 years or older, those with a GFR of 30 ml/minute/1.73 m(2) or lower, and those who received concurrent intermediate- or long-acting insulin during inpatient sulfonylurea therapy. Sulfonylureas should be avoided or used with caution in these patients.
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Glimepiride (GLI) is prescribed for the management of type-2 diabetes where as pitavastatin (PIT) for the treatment of diabetes associated dyslipidemia. Both the drugs are metabolized by CYP2C9 and have the potential of altering the enzyme through either inhibition or induction. In this respect, we present a simple, fast and validated bioanalytical LC-MS/MS method for the simultaneous estimation of GLI and PIT from rat plasma. Waters XTerra RP HPLC column (4.6×100mm, 5μm) with mobile phase consisting of acetonitrile and 10mM ammonium acetate (pH-6.0) in the ratio 85:15 (v/v) at a flow rate of 1mL/min was used for the chromatographic separation. The negative ionization mode with MRM transitions: m/z 420.17→288.13 for PIT, m/z 489.59→350.12 for GLI and m/z 380.08→316.31for celecoxib as internal standard (IS). A total run time of 3min and LLOQ was found to be 5ng/mL for both PIT and GLI. The method was applied to study the drug interaction between GLI and PIT in rat liver microsomes. In vivo rat pharmacokinetics study showed there was a 1.29-fold increase in AUC0-∞ and 1.2-fold decrease in the clearance of PIT in presence of GLI. No notable difference in the pharmacokinetic profile of GLI was observed upon the intravenous co-administration of PIT.
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The method was validated for linearity, recovery accuracy, intra- and inter-day precision, specificity in the presence of excipients, and inter-day stability under laboratory conditions. Student's t test at the 95% confidence limit was used for statistics.
In this multicenter, phase III, open-label evaluation, eligible patients had to have a glycosylated hemoglobin (HbA(1c)) level of ≥7.4% and <10.4% halfway through a 4-week run-in period while being treated with glimepiride 1 or 3 mg once daily plus diet and exercise. At baseline, patients were assigned to 8 weeks of treatment with pioglitazone/glimepiride (15 mg/1 mg) FDC once daily (group A; n=31) or pioglitazone/glimepiride (30 mg/3 mg) FDC once daily (group B; n=31) according to their glimepiride dose during run-in.
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No statistically significant difference in overall mortality risk was observed among the different combinations of sulfonylureas and metformin: glimepiride and metformin vs. glipizide and metformin (HR 1.03; 95% CI 0.89-1.20), glimepiride and metformin vs. glyburide (glibenclamide) and metformin (HR 1.08; 95% CI 0.90-1.30), or with glipizide and metformin vs. glyburide (glibenclamide) and metformin (HR 1.05; 95% CI 0.95-1.15).
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None of the anti-T2DM drugs had any effect on tofogliflozin exposure. Tofogliflozin had no or little effect on the exposure of any anti-T2DM drug. No anti-T2DM drug had any major effect on the cumulative urine glucose excretion induced by tofogliflozin. There were no safety concerns evident after administration of any drug alone or in co-administration.
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Sulfonylureas are widely used as an antidiabetic drug. In the present study, the effects of sulfonylurea administered supraspinally on immobilization stress-induced blood glucose level were studied in ICR mice. Mice were once enforced into immobilization stress for 30 min and returned to the cage. The blood glucose level was measured 30, 60, and 120 min after immobilization stress initiation. We found that intracerebroventricular (i.c.v.) injection with 30 µg of glyburide, glipizide, glimepiride or tolazamide attenuated the increased blood glucose level induced by immobilization stress. Immobilization stress causes an elevation of the blood corticosterone and insulin levels. Sulfonylureas pretreated i.c.v. caused a further elevation of the blood corticosterone level when mice were forced into the stress. In addition, sulfonylureas pretreated i.c.v. alone caused an elevation of the plasma insulin level. Furthermore, immobilization stress-induced insulin level was reduced by i.c.v. pretreated sulfonylureas. Our results suggest that lowering effect of sulfonylureas administered supraspinally against immobilization stress-induced increase of the blood glucose level appears to be primarily mediated via elevation of the plasma insulin level.
In isolated pancreatic islets of mice, the relationships between free glimepiride concentration and membrane binding or inhibition of ATP-sensitive K+ channels were examined. Microsomal membrane binding and K+ channel inhibition were half-maximal at 0.7 and 0.3 nmol/l glimepiride, respectively. The corresponding concentrations for glibenclamide were 0.4 and 0.6 nmol/l. Administration of glimepiride (10 nmol/l) or glibenclamide (10 nmol/l) to isolated mouse islets perifused with albumin-containing media induced a slow increase in insulin secretion. The kinetics of the secretory responses to glimepiride and glibenclamide were identical. Determination of albumin binding revealed that the free glimepiride and glibenclamide concentrations applied in our investigation were in the range of therapeutic serum concentrations of the free drugs. It is concluded that the effects of glimepiride and glibenclamide are very similar in mouse beta-cells.
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Rate of positive cases, laboratory findings, possible causes, age distribution, and final outcomes.
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The incidence of nocturnal hypoglycemia was equivalent between the two groups, with morning glargine non-inferior to bedtime (13.0 VS. 14.9 % of patients; between-treatment difference -1.9 %; one-sided 95 % confidence interval -100 %; 2.84 %). At endpoint, similar improvements in glycemic control were observed with morning compared to bedtime glargine: HbA1c: -1.65 +/- 1.21 VS. -1.57 +/- 1.16 %; p = 0.42; fasting blood glucose: -4.25 +/- 2.82 VS. -4.48 +/- 2.75 mmol/l; p = 0.08. The endpoint mean daily glargine dose was comparable (34.7 +/- 17.4 VS. 32.4 +/- 17.0 IU; p = 0.15), and there was no significant between-treatment difference in the change in body weight (2.1 VS. 1.8 kg; p = 0.39).
Glimepiride is an oral sulfonylurea antihyperglycemic agent indicated for the treatment of type 2 diabetes mellitus. Although there are reports in the literature regarding the pharmacokinetic (PK) characteristics of glimepiride, few data of PK parameters are available in a Chinese population; none are available regarding a recently developed generic formulation.
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A PubMed search was completed to identify publications from 1947 to October 2014 using the search terms dulaglutide and LY2189265. References were reviewed to identify additional resources.
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The mean baseline HbA1c was 7.8% in both the sitagliptin group (n = 197) and the glimepiride group (n = 191). After 30 weeks, the least squares (LS) mean change in HbA1c baseline was -0.32% with sitagliptin and -0.51 % with glimepiride, for a between-group difference (95% CI) of 0.19% (0.03-0.34). This result met the pre-specified criterion for declaring non-inferiority, which required that the upper 95% confidence limit lie below 0.4%. The LS mean change in FPG from baseline was -14.5 mg/dL with sitagliptin and -21.2 mg/dL with glimepiride, for a between-group difference (95% CI) of 6.7 mg/dL (0.7-12.7). The percentages of patients with adverse events of symptomatic hypoglycemia were 0.8% in the sitagliptin group and 4.7% in the glimepiride group (between-treatment difference = -3.9%, p = 0.009). The LS mean change in body weight from baseline was 0.4 kg with sitagliptin and 1.1 kg with glimepiride, for a between-group difference of -0.7 kg (p = 0.011).
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Pharmaceutical counterfeiting is becoming a serious problem in the world, especially in developing countries including China. Herein an isocratic reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for screening counterfeit medicines and adulterated dietary supplement products. The developed method could be employed to separate and determine simultaneously six anti-diabetic drugs (glipizide, gliclazide, glibenclamide, glimepiride, gliquidone, repaglinide) on an isocratic solvent system using an Alltima C18 column (5 microm, 150 mmx4.6 mm) with an isocratic mobile phase of methanol-phosphate buffer (pH 3.0; 0.01 mol/L) (70:30, v/v), at a flow rate of 1.0 mL/min and at a wavelength of 230 nm. The proposed method was successfully applied to the analysis of medicinal and dietary supplement samples purchased from the local market in China.
A 52-week, double-blinded, active-controlled, parallel-group, multi-centre, prospective trial, involving 746 subjects was conducted in the USA and Mexico. In Mexico, 171 subjects were rando-mised (1:1:1) to once daily liraglutide (either 1.2, or 1.8 mg/day injected subcutaneously) or glimepiride (8 mg/day orally).
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As weight gain and hypoglycaemia associated with glimepiride therapy can negatively impact weight perceptions, psychological well-being and overall quality of life in type 2 diabetes, we investigated whether liraglutide treatment could improve these factors.
Type 2 diabetes patients (aged ≥18 years) were randomized to Sita/Met or glimepiride for 30 weeks after a wash-off run-in period. The primary endpoint was change from baseline (CFB) in HbA1c. Secondary endpoints included the proportion of patients achieving target goal (HbA1c < 7.0 % [53 mmol/mol]) and CFB in fasting plasma glucose (FPG). Safety assessments comprised weight gain from baseline and the incidence of adverse events (AEs).
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Canagliflozin 100 and 300 mg provided reductions in HbA1c, body weight, and systolic BP across studies in patients from Latin America that were generally similar to those seen in the overall populations of patients with T2DM. The AE profile in patients from Latin America was equivalent to that in the overall populations; higher rates of genital mycotic infections and osmotic diuresis-related AEs were seen with canagliflozin versus comparators. Limitations of this study include the post hoc analysis of data and the small sample size of patients from Latin America.
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Liraglutide, a glucagon-like peptide (GLP-1) receptor agonist, has showed favorable effects in the glycaemic control and weight reduction in patients with type 2 diabetes mellitus (T2DM). The meta-analysis was to compare the efficacy and safety of liraglutide added to metformin with other treatments in patients with T2DM. A systematic literature search on PubMed, Embase, Web of Science and the Cochrane library databases were performed. Eligible studies were randomized controlled trials (RCTs) of patients with T2DM who received the combination treatment of liraglutide and metformin. Pooled estimates were performed using a fixed-effects model or random-effects model. A total of nine RCTs met the inclusion criteria. Compared with control (placebo, sitagliptin, glimepiride, dulaglutide, insulin glargine, and NPH), liraglutide in combination with metformin resulted in significant reductions in HbA1c, bodyweight, FPG, and PPG, and similar reductions in SBP, and DBP. Moreover, liraglutide combined with metformin did not increase the risk of hypoglycemia, but induced a higher incidence of gastrointestinal disorders. In conclusion, this meta-analysis confirmed the use of liraglutide as add-on to metformin appeared to be effective and safe for patients with T2DM. However, considering the potential limitations in this study, more large-scale, well-conducted RCTs are needed to identify our findings.
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There was no statistically significant difference between glimepiride and pioglitazone with respect to glycemic control, and both agents were well tolerated. Glimepiride significantly lowered total cholesterol and LDL-cholesterol, whereas pioglitazone increased HDL-cholesterol. This trial was registered with University Hospital Medical Information Network (UMIN), Japan, UMIN000004582. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00115.x, 2011).
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Across a wide spectrum of baseline A1C categories, liraglutide is an efficacious treatment option for patients with type 2 diabetes.
The method was proved to be simple, rapid, precise, accurate, and cost effective.
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New type 2 diabetic subjects, aged 30-60 years with BMI < 30 kg/m2 were selected. Subjects having glycosylated haemoglobin (HbA1c) of < 8.5% were advised diet and exercise (control group). Others having HbA1c > or = 8.5 to 11.0% were randomized to receive glimepiride (group 2), metformin (group 3) and pioglitazone (group 4). At the final review between 12-14 weeks, changes in plasma glucose, HbA1c, lipid profile, HOMA insulin resistance (HOMA-IR), beta cell function (HOMA-BF) and insulinogenic index (delta I/G) were measured. Comparisons were made using appropriate statistical analyses.