title: The rationale and design of the Glycemic Effects in Diabetes Mellitus Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) trial.
abstract: Beta-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 beta-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 beta-blockers have unique properties, including alpha1-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 (carvedilol) with a second-generation beta-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 HbA1c 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 beta-blocker yields a favorable metabolic profile in the patient with Type 2 diabetes and hypertension.
authors.affiliation: Rush Hypertension Center, Rush Medical Center, Suite 470, 1700 W. Van Buren, Chicago, IL 60612, USA. gbakris@rush.edu
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
authors.forename: David S H
authors.initials: DS
authors.lastname: Bell
authors.forename: Vivian
authors.initials: V
authors.lastname: Fonseca
authors.forename: Richard
authors.initials: R
authors.lastname: Katholi
authors.forename: Janet
authors.initials: J
authors.lastname: McGill
authors.forename: Robert
authors.initials: R
authors.lastname: Phillips
authors.forename: Philip
authors.initials: P
authors.lastname: Raskin
authors.forename: Jackson T
authors.initials: JT
authors.lastname: Wright
authors.forename: Malini
authors.initials: M
authors.lastname: Iyengar
authors.forename: Terry
authors.initials: T
authors.lastname: Holeslaw
authors.forename: Karen M
authors.initials: KM
authors.lastname: Anderson
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D002227:Carbazoles / Q000627:therapeutic use*; D000077261:Carvedilol; D003925:Diabetic Angiopathies / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008790:Metoprolol / Q000627:therapeutic use*; D008875:Middle Aged; D011412:Propanolamines / Q000627:therapeutic use*
chemical_list: D000319:Adrenergic beta-Antagonists; D001786:Blood Glucose; D002227:Carbazoles; D011412:Propanolamines; D000077261:Carvedilol; D008790:Metoprolol