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Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: carvedilol (Drug); metoprolol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

To evaluate the effects of two different antihypertensive medications in the drug class of beta-blockers on control of glucose in Type II diabetic patients with high blood pressure.

Clinical Details

Official title: A Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients With Type II Diabetes Mellitus.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline in HbA1c at 5 months

Secondary outcome: Blood pressure at 3 and 5 months. Body weight at 3 and 5 months. Lab values (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months.

Eligibility

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Patients at screening must be insulin producing Type II diabetics (C peptide

positive).

- Must have a history of mild to moderate hypertension (140-179 systolic; 90-1-9

diastolic).

- Must be on stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin

receptor blocker) treatment alone or in combination with other treatments.

- Patient''s laboratory result for HbA1c must be 6. 5 - 8. 5 (drug treated) or 6. 5 - 7. 5

(diet alone).

- Must be on a stable antidiabetic regimen (drug treated or diet alone).

Exclusion criteria:

- Patients using beta-blocker therapy.

Locations and Contacts

GSK Investigational Site, Glendale, Arizona 85306, United States

GSK Investigational Site, Phoenix, Arizona 85016, United States

GSK Investigational Site, Phoenix, Arizona 85050, United States

GSK Investigational Site, Tucson, Arizona 85724, United States

GSK Investigational Site, Burlingame, California 94010, United States

GSK Investigational Site, Concord, California 94520, United States

GSK Investigational Site, Encinitas, California 92024, United States

GSK Investigational Site, Hemet, California 92543, United States

GSK Investigational Site, Long Beach, California 90806, United States

GSK Investigational Site, Orange, California 92868, United States

GSK Investigational Site, Pasadena, California 91105, United States

GSK Investigational Site, Riverside, California 92501, United States

GSK Investigational Site, San Diego, California 92102, United States

GSK Investigational Site, San Luis Obispo, California 93405, United States

GSK Investigational Site, Spring Valley, California 91978, United States

GSK Investigational Site, Aurora, Colorado 80045, United States

GSK Investigational Site, Denver, Colorado 80220, United States

GSK Investigational Site, Golden, Colorado 80401, United States

GSK Investigational Site, Panama City, Florida 32401, United States

GSK Investigational Site, St. Petersburg, Florida 33701, United States

GSK Investigational Site, Honolulu, Hawaii 96813, United States

GSK Investigational Site, Idaho Falls, Idaho 83404, United States

GSK Investigational Site, Chicago, Illinois 60612, United States

GSK Investigational Site, O'Fallon, Illinois 62269, United States

GSK Investigational Site, Elkhart, Indiana 46515, United States

GSK Investigational Site, Indianapolis, Indiana 46260, United States

GSK Investigational Site, Iowa City, Iowa 52242, United States

GSK Investigational Site, Kalamazoo, Michigan 49009, United States

GSK Investigational Site, Oak Park, Michigan 48237, United States

GSK Investigational Site, Minneapolis, Minnesota 55417, United States

GSK Investigational Site, Kansas City, Missouri 64106, United States

GSK Investigational Site, Kansas City, Missouri 64111, United States

GSK Investigational Site, St. Louis, Missouri 63110, United States

GSK Investigational Site, St. Louis, Missouri 63128, United States

GSK Investigational Site, Las Vegas, Nevada 89103, United States

GSK Investigational Site, Albuquerque, New Mexico 87131, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States

GSK Investigational Site, Bend, Oregon 97701, United States

GSK Investigational Site, Oregon City, Oregon 97045, United States

GSK Investigational Site, Dallas, Texas 75390, United States

GSK Investigational Site, Fort Worth, Texas 76104, United States

GSK Investigational Site, Georgetown, Texas 78626, United States

GSK Investigational Site, Midland, Texas 79705, United States

GSK Investigational Site, San Antonio, Texas 78259, United States

GSK Investigational Site, San Antonio, Texas 78299, United States

GSK Investigational Site, The Colony, Texas 75056, United States

GSK Investigational Site, Ogden, Utah 84401, United States

GSK Investigational Site, Renton, Washington 98055, United States

GSK Investigational Site, Madison, Wisconsin 53792, United States

GSK Investigational Site, Milwaukee, Wisconsin 53151, United States

Additional Information

Starting date: June 2001
Last updated: April 14, 2015

Page last updated: August 23, 2015

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