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 (US)
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

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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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