Metformin treatment has been the most recommended monotherapy of type 2 diabetes mellitus (T2DM) for decades but is challenged by new antidiabetic drugs. This study conducted a meta-analysis of randomized controlled trials (RCT) comparing the efficacy of metformin and glimepiride in monotherapy of T2DM.
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After 6-months treatment, fasting plasma glucose and HbA1c values were comparably reduced in both groups. Anagliptin, but not glimepiride treatment significantly decreased low-density lipoprotein cholesterol, malondialdehyde-modified LDL, remnant-like particle (RLP) cholesterol, CAVI, alanine transaminase (ALT), γ-glutamyl transferase and visceral fat volume. In multiple regression analysis, absolute changes from baseline of RLP cholesterol and ALT after anagliptin treatment for 6 months (ΔRLP cholesterol and ΔALT) were independently correlated with ΔCAVI (R2=0.445).
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In SH associated with glimepiride therapy, no correlation between glimepiride serum concentrations and the protracted stimulation of insulin and C-peptide was observed. The secretion of glucagon and epinephrine as counterregulatory hormonal responses was unaffected. Protracted increased release of cortisol might be a medium-term indicator of glimepiride-associated SH.
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Clinical trial registry name: CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride.
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This study compared the effect of Glimepiride versus Vildagliptin on β-cell function and the release of intact proinsulin (PI) in patients with type 2 diabetes mellitus. Patients on metformin monotherapy were randomized to add on treatment with Vildagliptin or Glimepiride. A standardized test meal was given at baseline, after 12 and 24 weeks of treatment. Insulin, PI and blood glucose values were measured in the fasting state and postprandial for 300 min. Fasting PI levels significantly decreased in the Vildagliptin group. The area under the curve for the postprandial release of PI decreased during Vildagliptin and increased during Glimepiride treatment. The proinsulin to insulin ratio declined in the Vildagliptin group, whereas it did not change significantly in the Glimepiride group. Addition of Vildagliptin to ongoing Metformin treatment reconstitutes the disproportionality of the proinsulin to insulin secretion from the β cell.
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HbA1C levels were < 7.0% in all subjects at the end of the study. The daily insulin dose (units), total and per kg/BW was significantly lower [p < 0.001] with metformin (51 +/- 5, 0.51 +/- 0.10), glimepiride (40 +/- 4, 0.42 +/- 0.09) as well as with both drugs (23 +/- 7, 0.21 +/- 0.07) in comparison to placebo (82 +/- 10, 0.82 +/- 0.12). The insulin dose was also significantly lower [p < 0.05] in subjects on both drugs than subjects receiving them individually. Weight gain was less [p < 0.001] with metformin [2.5 +/- 0.74 kg], glimepiride [2.3 +/- 0.7 kg], and both drugs [2.2 +/- 0.61 kg] in comparison to placebo [5.2 +/- 1.4 kg] whereas the hypoglycemic episodes were lesser with metformin (3.8 +/- 1.2) and glimepiride (3.3 +/- 0.9) and least with both drugs (2.5 +/- 0.6) in comparison to placebo (5.2 +/- 1.0).
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In total, 519 patients (87.1%) completed the study. At 48 weeks, HbA1c adjusted mean changes from baseline for the placebo versus dapagliflozin 2.5/5/10-mg groups were -0.04% versus -0.41%, -0.56% and -0.73%, respectively. There were no meaningful differences in HbA1c changes from baseline from 24 to 48 weeks, indicating that glycemic efficacy was maintained. Improvements in fasting plasma glucose and post-challenge plasma glucose were also observed with dapagliflozin over 48 weeks. Dapagliflozin 2.5/5/10 mg produced sustained reductions in weight (-1.36/-1.54/-2.41 kg) versus placebo (-0.77 kg). Adjusted mean reductions from baseline in systolic blood pressure were also greater than placebo for all dapagliflozin doses. In the placebo versus dapagliflozin groups, serious adverse events were 8.9% versus 8.6-11.0%, hypoglycemic events were 6.8% versus 9.7-11.3%, and events suggestive of genital infection were 1.4% versus 5.2-8.6%.
Thermal behavior of some antidiabetic drugs such as pioglitazone hydrochloride (PTZ), rosiglitazone maleate (RGZ), glibenclamide (GBD) and glimepiride (GMP) has been studied.
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Patients aged 35-70 years with poorly controlled diabetes [fasting plasma glucose (FPG) > or =1,40 g/l and < 3 g/l at baseline] were treated with glimepiride for 6 months, with dosage titrated from 1-6 mg daily, depending on the monthly FPG measurement. Responders were defined as patients with a) FPG < 7.78 mmol/l (1.40 g/l) and HbA(1c) < 7.5% at endpoint, or b) decrease in FPG > or = 20% and/or HbA1c > or = 10%. Stepwise logistic regression analysis was used to identify factors predictive of response.
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The present study was performed to investigate potential of Eudragit RLPO-based nanosuspension of glimepiride (Biopharmaceutical Classification System class II drug), for the improvement of its solubility and overall therapeutic efficacy, suitable for peroral administration. Nanoprecipitation method being simple and less sophisticated was optimized for the preparation of nanosuspension. Physicochemical characteristics of nanosuspension in terms of size, zeta potential, polydispersity index, entrapment efficiency (% EE) and in vitro drug release were found within their acceptable ranges. The size of the nanoparticles was most strongly affected by agitation time while % EE was more influenced by the drug/polymer ratio. Differential scanning calorimetry and X-ray diffraction studies provided evidence that enhancement in solubility of drug resulted due to change in crystallinity of drug within the formulation. Stability study revealed that nanosuspension was more stable at refrigerated condition with no significant changes in particle size distribution, % EE, and release characteristics for 3 months. In vivo studies were performed on nicotinamide-streptozotocin-induced diabetic rat models for pharmacokinetic and antihyperglycaemic activity. Nanosuspension increased maximum plasma concentration, area under the curve, and mean residence time values significantly as compared to aqueous suspension. Oral glucose tolerance test and antihyperglycaemic studies demonstrated plasma glucose levels were efficiently controlled in case of nanosuspension than glimepiride suspension. Briefly, sustained and prolonged activity of nanosuspensions could reduce dose frequency, decrease drug side effects, and improve patient compliance. Therefore, glimepiride nanosuspensions can be expected to gain considerable attention in the treatment of type 2 diabetes mellitus due to its improved therapeutic activity.
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In total, 1041 adults (mean +/- sd), age 56 +/- 10 years, weight 82 +/- 17 kg and glycated haemoglobin (HbA(1c)) 8.4 +/- 1.0% at 116 sites in 21 countries were stratified based on previous oral glucose-lowering mono : combination therapies (30 : 70%) to participate in a five-arm, 26-week, double-dummy, randomized study.
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Once-daily alogliptin was effective and generally well tolerated when given as add-on therapy to glimepiride in Japanese patients with type 2 diabetes who had inadequate glycemic control on sulfonylurea plus lifestyle measures. Clinical benefits were maintained for 52 weeks. This trial was registered with ClinicalTrials.gov (double-blind study no. NCT01318083; long-term study no. NCT01318135).
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Our results demonstrate that the ring-fused pyrrole moiety in several A-site drugs likely underlies the observed inhibitory potency of these drugs on KATP channels containing the K23/A1369 risk haplotype. It may therefore be possible to tailor existing therapy or design novel drugs that display an increased efficacy in type 2 diabetes patients homozygous for these common KATP channel haplotypes.
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Patients with type 2 diabetes mellitus should be routinely counseled about the use of herbal products to minimize the risk of ADRs.