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

NCT00744237 | Completed Phase 4 Results

• 1 other identifier: NEB-MD-19
• Study Type: interventional
• Target: 231
• Locations: 2 countries
• Sites: 65

Brief Summary

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

Conditions

Hypertension; Type 2 Diabetes Mellitus

Keywords

nebivolol; Bystolic ™; Hypertension; Diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26

  Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.

  visit 5(week 0) and visit 14(week 26)

Secondary Outcomes (1)

• Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

  [visit 5(week 0) and visit 14(week 26)]

Study Arms (3)

1

EXPERIMENTAL

* 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

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

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

Interventions

Nebivolol DRUG

* 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

Also known as: Bystolic (TM)

1

Metoprolol ER DRUG

* 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

2

HCTZ DRUG

* HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration * HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration

Also known as: Hydrochlorothorazide

3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (65)

Forest Investigative Site 15

Athens, Alabama, 35611, United States

Location

Forest Investigative Site 16

Huntsville, Alabama, 35801, United States

Location

Forest Investigative Site 35

Bell Gardens, California, 90201, United States

Location

Forest Investigative Site

Buena Park, California, 90620, United States

Location

Forest Investigative Site 54

Chino, California, 91710, United States

Location

Forest Investigative Site 40

Fremont, California, 94538, United States

Location

Forest Investigative Site

Palm Springs, California, 92262, United States

Location

Forest Investigative Site

Pomona, California, 91767, United States

Location

Forest Investigative Site 55

Sacramento, California, 95821, United States

Location

Forest Investigative Site 11

San Diego, California, 92128, United States

Location

Forest Investigative Site

Santa Monica, California, 90404, United States

Location

Forest Investigative Site

Spring Valley, California, 91978, United States

Location

Forest Investigative Site 49

Tustin, California, 92780, United States

Location

Forest Investigative Site 47

Walnut Creek, California, 94598, United States

Location

Forest Investigative Site 61

Golden, Colorado, 80401, United States

Location

Forest Investigative Site

Wheat Ridge, Colorado, 80033, United States

Location

Forest Investigative Site 3

Daytona Beach, Florida, 32117, United States

Location

Forest Investigative Site 33

DeLand, Florida, 32720, United States

Location

Forest Investigative Site 36

Hollywood, Florida, 33023, United States

Location

Forest Investigative Site 62

Miami, Florida, 33135, United States

Location

Forest Investigative Site 080

Miami, Florida, 33169, United States

Location

Forest Investigative Site 59

Miami, Florida, 33183, United States

Location

Forest Investigative Site 32

Pembroke Pines, Florida, 33024, United States

Location

Forest Investigative Site 081

Pembroke Pines, Florida, 33028, United States

Location

Forest Investigative Site 2

Tamarac, Florida, 33321, United States

Location

Forest Investigative Site

Tampa, Florida, 33612, United States

Location

Forest Investigative Site 19

West Palm Beach, Florida, 33401, United States

Location

Forest Investigative Site 44

Atlanta, Georgia, 30312, United States

Location

Forest Investigative Site 5

Augusta, Georgia, 30904, United States

Location

Forest Investigative Site 56

Honolulu, Hawaii, 96814, United States

Location

Forest Investigative Site 57

Meridian, Idaho, 83646, United States

Location

Forest Investigative Site 39

Chicago, Illinois, 60607, United States

Location

Forest Investigative Site 37

Wichita, Kansas, 67203, United States

Location

Forest Investigative Site

Baltimore, Maryland, 21204, United States

Location

Forest Investigative Site 20

Baltimore, Maryland, 21209, United States

Location

Forest Investigative Site 50

Oxon Hill, Maryland, 20745, United States

Location

Forest Investigative Site 21

Saint Clair Shores, Michigan, 48081, United States

Location

Forest Investigative Site

Kansas City, Missouri, 64111, United States

Location

Forest Investigative Site

St Louis, Missouri, 63110, United States

Location

Forest Investigative Site

New Hyde Park, New York, 11042, United States

Location

Forest Investigative Site

New York, New York, 10032, United States

Location

Forest Investigative Site 7

Charlotte, North Carolina, 28211, United States

Location

Forest Investigative Site 45

Charlotte, North Carolina, 28262, United States

Location

Forest Investigative Site 24

Morehead City, North Carolina, 28557, United States

Location

Forest Investigative Site 26

Salisbury, North Carolina, 28144, United States

Location

Forest Investigative Site 18

Wilmington, North Carolina, 28401, United States

Location

Forest Investigative Site 51

Centerville, Ohio, 45459, United States

Location

Forest Investigative Site 48

Cincinnati, Ohio, 45242, United States

Location

Forest Investigative Site 12

Wadsworth, Ohio, 44281, United States

Location

Forest Investigative Site 17

Charleston, South Carolina, 29407, United States

Location

Forest Investigative Site 46

Columbia, South Carolina, 29201, United States

Location

Forest Investigative Site

North Charleston, South Carolina, 29406, United States

Location

Forest Investigative Site

Simpsonville, South Carolina, 29681, United States

Location

Forest Investigative Site 4

Sioux Falls, South Dakota, 57104, United States

Location

Forest Investigative Site 10

New Tazewell, Tennessee, 37825, United States

Location

Forest Investigative Site 52

Corpus Christi, Texas, 78404, United States

Location

Forest Investigative Site 28

Dallas, Texas, 75390, United States

Location

Forest Investigative Site 38

Hurst, Texas, 76054, United States

Location

Forest Investigative Site 34

Salt Lake City, Utah, 84102, United States

Location

Forest Investigative Site

St. George, Utah, 84790, United States

Location

Forest Investigative Site

Norfolk, Virginia, 23502, United States

Location

Forest Investigative Site 31

Virginia Beach, Virginia, 23452, United States

Location

Forest Investigative Site 41

Ponce, 00717, Puerto Rico

Location

Forest Investigative Site 60

Salinas, 00751, Puerto Rico

Location

Forest Investigative Site 29

Santurce, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Nebivolol; Metoprolol; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Propanols; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Results Point of Contact

• Title: Noah Rosenberg , MD, Exec. Dir, Clin Dev, Cardiovascular and Metabolism
• Organization: Forest Laboratories, Inc

noah.rosenberg@frx.com

2014278000

Study Officials

• John Shea, MS

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Last Updated: July 29, 2011
• Results First Posted: July 29, 2011

Record last verified: 2011-06

Locations

PR (3); US (62)