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 Citations (Scopus)

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 - Mar 2005

Fingerprint

Metoprolol
Insulin Resistance
Diabetes Mellitus
Hypoglycemia
Type 2 Diabetes Mellitus
Outcome Assessment (Health Care)
Hypertension
Metabolome
Peripheral Vascular Diseases
Arterioles
Erectile Dysfunction
Vasoconstriction
Fatigue
Fasting
Extremities
Lipids
Glucose
carvedilol

Keywords

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

ASJC Scopus subject areas

  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

The rationale and design of the Glycemic Effects in Diabetes Mellitus : Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) trial. / Bakris, George L.; Bell, David S H; Fonseca, Vivian; Katholi, Richard; McGill, Janet; Phillips, Robert; Raskin, Philip; Wright, Jackson T.; Iyengar, Malini; Holeslaw, Terry; Anderson, Karen M.

In: Journal of Diabetes and its Complications, Vol. 19, No. 2, 03.2005, p. 74-79.

Research output: Contribution to journalArticle

Bakris, GL, Bell, DSH, Fonseca, V, Katholi, R, McGill, J, Phillips, R, Raskin, P, Wright, JT, Iyengar, M, Holeslaw, T & Anderson, KM 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, vol. 19, no. 2, pp. 74-79. https://doi.org/10.1016/j.jdiacomp.2004.07.003
Bakris, George L. ; Bell, David S H ; Fonseca, Vivian ; Katholi, Richard ; McGill, Janet ; Phillips, Robert ; Raskin, Philip ; Wright, Jackson T. ; Iyengar, Malini ; Holeslaw, Terry ; Anderson, Karen M. / The rationale and design of the Glycemic Effects in Diabetes Mellitus : Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) trial. In: Journal of Diabetes and its Complications. 2005 ; Vol. 19, No. 2. pp. 74-79.
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