Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients

Condition(s) targeted: Hypertension; Type 2 Diabetes Mellitus

Intervention: Nebivolol (Drug); Metoprolol ER (Drug); HCTZ (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
John Shea, MS, Study Director, Affiliation: Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

Overall contact:
Sandra Beaird, PharmD, Phone: 800-678-1605, Ext: 66297, Email: info@forestpharma.com

This study will evaluate the effects of nebivolol on glycemic control compared with metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus

Official title: Glycemic Effects of Nebivolol Compared With Metoprolol Extended Release and Compared With Hydrochlorothiazide In Hypertensive Patients With Type 2 Diabetes Mellitus: A Pilot Study

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in glycosylated hemoglobin (HbA1c) over 26 weeks

Secondary outcome: Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR)

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

INCLUSION CRITERIA:

- Male or female, 18-85 years of age

- Blood pressure in the range of 130 to 179/80 to 109 mmHg

- Currently using either an ACE inhibitor or an ARB alone or (an ACE inhibitor or an

ARB and up to two other drugs for treatment of high blood pressure). (Patients may be on both an ACE inhibitor and ARB, but would need to be taken off one.)

- Stable medication regimen for high blood pressure for at least one month prior to

screening

- Stable type 2 diabetes mellitus for at least 3 months prior to screening that is

controlled by any or all of the following: diet and antidiabetic medications that may include fixed-dose insulin

- HgbA1c 6. 5 to 8. 5% (This is measured at the screening visit)

EXCLUSION CRITERIA:

- Use of any beta blocker within one month prior to screening

- Use of clonidine within 3 months prior to screening

- Diagnosis of hyperthyroidism as evidenced by abnormal lab markers

- Any disorder requiring the intermittent or chronic use of systemic corticosteroids

- Diagnosis of hyperthyroidism as determined by lab markers done at screening

- Active liver disease as determined by lab markers

- Kidney impairment; estimated GFR < 60 mL/min/1. 73 m2

- History of heart attack, clinically significant arrhythmia, unstable angina, coronary

angioplasty/bypass surgery, stroke, or TIA in 3 months prior to screening

- Chronic heart failure

- Drug or alcohol abuse within 2 years prior to screening

- History of sensitivity to any beta blocker, HCTZ, sulfa drug, or calcium channel

blocker

- Participation in another research study within 30 days prior to screening

Sandra Beaird, PharmD, Phone: 800-678-1605, Ext: 66297, Email: info@forestpharma.com

Forest Investigative Site 29, Santurce 00909, Puerto Rico; Active, not recruiting

Forest Investigative Site 60, Salinas 00751, Puerto Rico; Recruiting

Forest Investigative Site 41, Ponce 00717, Puerto Rico; Recruiting

Forest Investigative Site 15, Athens, Alabama 35611, United States; Recruiting

Forest Investigative Site 16, Huntsville, Alabama 35801, United States; Active, not recruiting

Forest Investigative Site 35, Bell Gardens, California 90201, United States; Recruiting

Forest Investigative Site 47, Walnut Creek, California 94598, United States; Recruiting

Forest Investigative Site 11, San Diego, California 92128, United States; Recruiting

Forest Investigative Site 40, Fremont, California 94538, United States; Terminated

Forest Investigative Site 49, Tustin, California 92780, United States; Recruiting

Forest Investigative Site 54, Chino, California 91710, United States; Terminated

Forest Investigative Site 55, Sacramento, California 95821, United States; Active, not recruiting

Forest Investigative Site, Spring Valley, California 91978, United States; Not yet recruiting

Forest Investigative Site, Pomona, California 91767, United States; Not yet recruiting

Forest Investigative Site, Santa Monica, California 90404, United States; Not yet recruiting

Forest Investigative Site, Buena Park, California 90620, United States; Not yet recruiting

Forest Investigative Site, Palm Springs, California 92262, United States; Not yet recruiting

Forest Investigative Site 61, Golden, Colorado 80401, United States; Recruiting

Forest Investigative Site, Wheat Ridge, Colorado 80033, United States; Not yet recruiting

Forest Investigative Site 32, Pembroke Pines, Florida 33024, United States; Recruiting

Forest Investigative Site 2, Tamarac, Florida 33321, United States; Terminated

Forest Investigative Site 3, Daytona Beach, Florida 32117, United States; Terminated

Forest Investigative Site 59, Miami, Florida 33183, United States; Recruiting

Forest Investigative Site 19, West Palm Beach, Florida 33401, United States; Recruiting

Forest Investigative Site 62, Miami, Florida 33135, United States; Recruiting

Forest Investigative Site 33, DeLand, Florida 32720, United States; Recruiting

Forest Investigative Site 36, Hollywood, Florida 33023, United States; Recruiting

Forest Investigative Site, Tampa, Florida 33612, United States; Not yet recruiting

Forest Investigative Site 5, Augusta, Georgia 30904, United States; Recruiting

Forest Investigative Site 44, Atlanta, Georgia 30312, United States; Recruiting

Forest Investigative Site 56, Honolulu, Hawaii 96814, United States; Recruiting

Forest Investigative Site 57, Meridian, Idaho 83646, United States; Recruiting

Forest Investigative Site 39, Chicago, Illinois 60607, United States; Recruiting

Forest Investigative Site 37, Wichita, Kansas 67203, United States; Recruiting

Forest Investigative Site 20, Baltimore, Maryland 21209, United States; Recruiting

Forest Investigative Site 50, Oxon Hill, Maryland 20745, United States; Recruiting

Forest Investigative Site, Baltimore, Maryland 21204, United States; Not yet recruiting

Forest Investigative Site 21, St. Clair Shores, Michigan 48081, United States; Recruiting

Forest Investigative Site, Kansas City, Missouri 64111, United States; Not yet recruiting

Forest Investigative Site, St. Louis, Missouri 63110, United States; Not yet recruiting

Forest Investigative Site, New York, New York 10032, United States; Not yet recruiting

Forest Investigative Site, New Hyde Park, New York 11042, United States; Not yet recruiting

Forest Investigative Site 18, Wilmington, North Carolina 28401, United States; Terminated

Forest Investigative Site 7, Charlotte, North Carolina 28211, United States; Active, not recruiting

Forest Investigative Site 45, Charlotte, North Carolina 28262, United States; Terminated

Forest Investigative Site 24, Morehead City, North Carolina 28557, United States; Recruiting

Forest Investigative Site 26, Salisbury, North Carolina 28144, United States; Terminated

Forest Investigative Site 12, Wadsworth, Ohio 44281, United States; Recruiting

Forest Investigative Site 48, Cincinnati, Ohio 45242, United States; Recruiting

Forest Investigative Site 51, Centerville, Ohio 45459, United States; Recruiting

Forest Investigative Site 17, Charleston, South Carolina 29407, United States; Recruiting

Forest Investigative Site 46, Columbia, South Carolina 29201, United States; Recruiting

Forest Investigative Site, North Charleston, South Carolina 29406, United States; Not yet recruiting

Forest Investigative Site, Simpsonville, South Carolina 29681, United States; Not yet recruiting

Forest Investigative Site 4, Sioux Falls, South Dakota 57104, United States; Recruiting

Forest Investigative Site 10, New Tazewell, Tennessee 37825, United States; Recruiting

Forest Investigative Site 28, Dallas, Texas 75390, United States; Recruiting

Forest Investigative Site 52, Corpus Christi, Texas 78404, United States; Recruiting

Forest Investigative Site 38, Hurst, Texas 76054, United States; Recruiting

Forest Investigative Site 34, Salt Lake City, Utah 84102, United States; Recruiting

Forest Investigative Site, St. George, Utah 84790, United States; Not yet recruiting

Forest Investigative Site, Norfolk, Virginia 23502, United States; Recruiting

Forest Investigative Site 31, Virginia Beach, Virginia 23452, United States; Terminated

Starting date: August 2008
Last updated: August 6, 2009