Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients - Full Text View

Purpose

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

Condition	Intervention	Phase
Hypertension Type 2 Diabetes Mellitus	Drug: Nebivolol Drug: Metoprolol ER Drug: HCTZ	Phase IV

MedlinePlus related topics:

Diabetes High Blood Pressure

Drug Information available for:

Metoprolol Metoprolol fumarate Metoprolol succinate Metoprolol Tartrate Hydrochlorothiazide Nebivolol

U.S. FDA Resources

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

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

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Glycosylated hemoglobin (HbA1c) [ Time Frame: visit 4 and visit 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: visit 4 and visit 14 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	August 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration Open-label amlodipine may be given	Drug: Nebivolol Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
2: Active Comparator Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration Open-label amlodipine may be given	Drug: Metoprolol ER Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
3: Active Comparator HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration Open-label amlodipine may be given	Drug: HCTZ HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration

Eligibility

Ages Eligible for Study:	22 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male and female outpatients 22-80 years of age
currently being treated with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)
currently on stable antidiabetic regimen for a minimum of prior 3 months and monitoring of blood glucose during study
qualifying laboratory results
meet criteria for stable type 2 diabetes mellitus and stage I or II hypertension

Exclusion Criteria:

secondary hypertension
taking insulin as part of antidiabetic medication regimen
history of hypoglycemic unawareness
pregnant or breastfeeding
evidence of other concurrent disease or conditions that might interfere with the conduct of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744237

Contacts


Contact: Sandra Beaird, PharmD	800-678-1605 ext 66297	info@forestpharma.com

Locations


United States, Alabama
	Forest Investigative Site	Recruiting
	Athens, Alabama, United States, 35611
	Forest Investigative Site	Recruiting
	Huntsville, Alabama, United States, 35801

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

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

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

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

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

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

United States, North Carolina
	Forest Investigative Site	Recruiting
	Durham, North Carolina, United States, 27704
	Forest Investigative Site	Recruiting
	Wilmington, North Carolina, United States, 28401

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

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

Sponsors and Collaborators

Forest Laboratories

Investigators


Study Director:	David Bharucha, MD, PhD	Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

More Information

Responsible Party:	Forest Research Institute, a Subsidiary of Forest Laboratories Inc. ( Leslie Lipka, MD, PhD/Executive Director )
Study ID Numbers:	NEB-MD-19
First Received:	August 27, 2008
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00744237
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

nebivolol

Bystolic ™

Hypertension

Diabetes

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus

Vascular Diseases

Endocrine System Diseases

Nebivolol

Metoprolol

Hydrochlorothiazide

Metoprolol succinate

Diabetes Mellitus, Type 2

Endocrinopathy

Glucose Metabolism Disorders

Metabolic disorder

Hypertension

Additional relevant MeSH terms:

Vasodilator Agents

Neurotransmitter Agents

Sympatholytics

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Adrenergic beta-Antagonists

Cardiovascular Diseases

Adrenergic Antagonists

Peripheral Nervous System Agents

Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00744237