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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 High Blood Pressure

Drug Information available for: Hydrochlorothiazide Metoprolol Metoprolol Tartrate Metoprolol succinate Nebivolol Metoprolol fumarate

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26 [ Time Frame: visit 5(week 0) and visit 14(week 26) ] [ Designated as safety issue: No ]
Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.

Secondary Outcome Measures:

Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: [visit 5(week 0) and visit 14(week 26)] ] [ Designated as safety issue: No ]
Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5

Enrollment:	231
Study Start Date:	August 2008
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 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 Other Name: Bystolic (TM)
Active Comparator: 2 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
Active Comparator: 3 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 Other Name: Hydrochlorothorazide

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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

Show 65 Study Locations

Sponsors and Collaborators

Forest Laboratories

Investigators

Study Director:

John Shea, MS

Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

More Information

No publications provided

Responsible Party:	John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a Subsidiary of Forest Laboratories Inc.
ClinicalTrials.gov Identifier:	NCT00744237 History of Changes
Other Study ID Numbers:	NEB-MD-19
Study First Received:	August 27, 2008
Results First Received:	June 30, 2011
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

nebivolol
Bystolic ™
Hypertension
Diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nebivolol
Hydrochlorothiazide
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012