The rationale and design of the Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) trial

George L. Bakris, David S.H. Bell, Vivian Fonseca, Richard Katholi, Janet McGill, Robert Phillips, Philip Raskin, Jackson T. Wright, Malini Iyengar, Terry Holeslaw, Karen M. Anderson

Research output: Contribution to journalArticle

17 Scopus citations

Abstract

β-blockers utilized in the Type 2 diabetic patient result in an even greater decrease in cardiac events than in the nondiabetic patient. Unfortunately, first-and second-generation β-blockers are associated with the worsening of insulin resistance, deterioration of glycemic control, peripheral vasoconstriction, potentially worsening peripheral vascular disease, and more frequent and severe hypoglycemia. The third-generation β-blockers have unique properties, including α1-blockade, and have been shown to lower insulin resistance, improve glycemic control, and vasodilate resistance arterioles. The Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) trial has been designed to compare a third-generation (cardevilol) with a second-generation β-blocker (metoprolol) in a cohort of participants with hypertension and Type 2 diabetes. The primary outcome measure of the study is change in the HbA1c. The study is powered to detect a difference in HbA 1c of 0.3 units (%) between the groups. Secondary endpoints include changes in insulin resistance, fasting glucose, and the lipid profile. Differences in the side-effect profile (cold extremities, fatigue, impotence, and hypoglycemia) will also be assessed. The GEMINI trial, therefore, is the first large randomized trial to assess whether utilizing a third-generation β-blocker yields a favorable metabolic profile in the patient with Type 2 diabetes and hypertension.

Original languageEnglish
Pages (from-to)74-79
Number of pages6
JournalJournal of Diabetes and Its Complications
Volume19
Issue number2
DOIs
StatePublished - Jan 1 2005

Keywords

  • Carvedilol
  • Clinical trial
  • Hypertension
  • Metoprolol
  • Type 2 diabetes
  • β-blockers

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    Bakris, G. L., Bell, D. S. H., Fonseca, V., Katholi, R., McGill, J., Phillips, R., Raskin, P., Wright, J. T., Iyengar, M., Holeslaw, T., & Anderson, K. M. (2005). The rationale and design of the Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) trial. Journal of Diabetes and Its Complications, 19(2), 74-79. https://doi.org/10.1016/j.jdiacomp.2004.07.003