caa a22 4500 475771869 CHVBK 20180406123619.0 cr unu---uuuuu 170329e20000301xx s 000 0 eng 10.1007/s001250050045 doi (NATIONALLICENCE)springer-10.1007/s001250050045 Rosiglitazone short-term monotherapy lowers fasting and post-prandial glucose in patients with Type II diabetes [Elektronische Daten] [P. Raskin, E. B. Rappaport, S. T. Cole, Y. Yan, R. Patwardhan, M. I. Freed] Abstract : Aims/hypothesis. The short-term efficacy, safety and tolerability of rosiglitazone were compared with placebo in patients with Type II (non-insulin-dependent) diabetes mellitus in a dose-ranging study.¶Methods. After a 2-week placebo run-in phase, 303 patients were randomly assigned to 8 weeks of treatment with twice-daily placebo or 2, 4 or 6 mg of rosiglitazone.¶Results. All rosiglitazone doses significantly reduced fasting plasma glucose compared with baseline. All rosiglitazone treatment groups showed significantly reduced peak postprandial glucose concentrations compared with baseline (p < 0.001) and with placebo (p < 0.0001) and reduced postprandial glucose excursion, without an increase in the area under the postprandial insulin concentration-time curve. Rosiglitazone at 4 and 6 mg twice daily prevented the increase in HbA1 c observed in the placebo group. C peptide and serum insulin concentrations were significantly reduced from baseline in all rosiglitazone treatment groups. In all rosiglitazone treatment groups, non-esterified fatty acids decreased significantly (p < 0.0001) and triglycerides did not change. Although total LDL and HDL cholesterol increased significantly in the rosiglitazone treatment groups, total cholesterol/HDL ratios did not change significantly. The proportion of patients with one or more adverse event was similar in all four treatment groups. No patient showed evidence of hepatotoxicity.¶Conclusion/interpretation. Rosiglitazone given twice daily significantly reduced fasting and postprandial glucose concentrations, C peptide, insulin and non-esterified fatty acids in Type II diabetic patients. The glucose-lowering effect of the 4-mg twice-daily dose of rosiglitazone was similar to that of 6-mg twice daily, suggesting that 4 mg twice daily should be the maximum clinical dose. [Diabetologia (2000) 43: 278-284] Springer-Verlag Berlin Heidelberg, 2000 Keywords Rosiglitazone, thiazolidinedione, insulin resistance, Type II diabetes, non-esterified fatty acids, efficacy nationallicence Raskin P. University of Texas Southwestern Medical Center, Dallas, Texas, USA, US aut Rappaport E. B. Clinical Research, Development and Medical Affairs North America, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA, US aut Cole S. T. Clinical Research, Development and Medical Affairs North America, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA, US aut Yan Y. Biometrics, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA, US aut Patwardhan R. Biometrics, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA, US aut Freed M. I. Clinical Research, Development and Medical Affairs North America, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA, US aut https://doi.org/10.1007/s001250050045 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s001250050045 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Raskin P. University of Texas Southwestern Medical Center, Dallas, Texas, USA, US aut NATIONALLICENCE 700 1- Rappaport E. B. Clinical Research, Development and Medical Affairs North America, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA, US aut NATIONALLICENCE 700 1- Cole S. T. Clinical Research, Development and Medical Affairs North America, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA, US aut NATIONALLICENCE 700 1- Yan Y. Biometrics, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA, US aut NATIONALLICENCE 700 1- Patwardhan R. Biometrics, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA, US aut NATIONALLICENCE 700 1- Freed M. I. Clinical Research, Development and Medical Affairs North America, SmithKline Beecham Pharmaceuticals, Collegeville, Pennsylvania, USA, US aut Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer