Rosiglitazone short-term monotherapy lowers fasting and post-prandial glucose in patients with Type II diabetes

Philip Raskin, E. B. Rappaport, S. T. Cole, Y. Yan, R. Patwardhan, M. I. Freed

Research output: Contribution to journalArticle

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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 HbA(1c) 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.

Original languageEnglish (US)
Pages (from-to)278-284
Number of pages7
JournalDiabetologia
Volume43
Issue number3
StatePublished - 2000

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rosiglitazone
Meals
Fasting
Insulin
Glucose
Placebos
C-Peptide
HDL Cholesterol
Fatty Acids
Therapeutics

Keywords

  • Efficacy
  • Insulin resistance
  • Non- esterified fatty acids
  • Rosiglitazone
  • Thiazolidinedione
  • Type II diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Raskin, P., Rappaport, E. B., Cole, S. T., Yan, Y., Patwardhan, R., & Freed, M. I. (2000). Rosiglitazone short-term monotherapy lowers fasting and post-prandial glucose in patients with Type II diabetes. Diabetologia, 43(3), 278-284.

Rosiglitazone short-term monotherapy lowers fasting and post-prandial glucose in patients with Type II diabetes. / Raskin, Philip; Rappaport, E. B.; Cole, S. T.; Yan, Y.; Patwardhan, R.; Freed, M. I.

In: Diabetologia, Vol. 43, No. 3, 2000, p. 278-284.

Research output: Contribution to journalArticle

Raskin, P, Rappaport, EB, Cole, ST, Yan, Y, Patwardhan, R & Freed, MI 2000, 'Rosiglitazone short-term monotherapy lowers fasting and post-prandial glucose in patients with Type II diabetes', Diabetologia, vol. 43, no. 3, pp. 278-284.
Raskin, Philip ; Rappaport, E. B. ; Cole, S. T. ; Yan, Y. ; Patwardhan, R. ; Freed, M. I. / Rosiglitazone short-term monotherapy lowers fasting and post-prandial glucose in patients with Type II diabetes. In: Diabetologia. 2000 ; Vol. 43, No. 3. pp. 278-284.
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AU - Raskin, Philip

AU - Rappaport, E. B.

AU - Cole, S. T.

AU - Yan, Y.

AU - Patwardhan, R.

AU - Freed, M. I.

PY - 2000

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N2 - 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 HbA(1c) 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.

AB - 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 HbA(1c) 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.

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KW - Thiazolidinedione

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