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Effect Of Saxagliptin On Monotherapy

Shanghai Chiral Chemicals Inc | Updated: Jul 01, 2017

  Effect of Saxagliptin on Monotherapy

  This study is a clinical phase III, multicenter, parallel, randomized, double-blind, placebo-controlled study of the age of 18 to 77 years of age, diet and exercise in patients with type 2 diabetes mellitus. The efficacy and safety of the initial treatment of saxagliptin were evaluated in type 2 diabetic patients who were able to control blood glucose and had not yet been treated with drugs. Patients with baseline HbA1c levels ≥7% and ≤ 10% were included in the main treatment cohort (MTC), once daily for oral administration of paclitaxel 2.5 mg, 5 mg, 10 mg or placebo for 6 months The HbA1c level> 10% and ≤12% into the open label queue (Open-Label Cohort, OLC), taking sag retinide 10 mg, once a day for 24 weeks.

  The results showed that in the MTC group, saxagliptin treatment significantly reduced the corrected mean HbA1c level compared to baseline, corrected mean FPG levels (-15 mg / dl, -9 mg / dl, -17 mg / dl vs. placebo (PPG-Area Under Curve, PPG-AUC) (-6868 mg.min / dl, -6896 mg.min / dl, -8084 mg.min / dl) for the comfort of the post-meal glucose curve area Dose group -647 mg.min / dl) was also significantly lower than the baseline, the proportion of patients markedly increased. OLC group of blood glucose indicators were significantly lower than the baseline. The incidence of adverse events was similar in the treatment group compared with the placebo group, and no symptomatic (finger blood glucose ≤ 50 mg / dl) hypoglycemic events were found. Saxagliptin treatment did not increase body weight. Therefore, for the newly diagnosed patients, whether it is 7% ≤ HbA1c ≤ 10%, or 10% ≤ HbA1c ≤ 12%, Saxagliptin once a day single drug treatment have significant blood glucose control, safety and tolerance Good sex.