Clinical trial NCT00744237: Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Type 2 Diabetes Mellitus
Keywords: nebivolol
Bystolic ™
Hypertension
Diabetes
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-08-29
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26
timeFrame: visit 5(week 0) and visit 14(week 26)
Secondary outcomes:
measure: Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: [visit 5(week 0) and visit 14(week 26)]
Other outcomes:
Locations:
city: Athens
country: United States
facility: Forest Investigative Site 15
state: Alabama
city: Huntsville
country: United States
facility: Forest Investigative Site 16
state: Alabama
city: Bell Gardens
country: United States
facility: Forest Investigative Site 35
state: California
city: Buena Park
country: United States
facility: Forest Investigative Site
state: California
city: Chino
country: United States
facility: Forest Investigative Site 54
state: California
city: Fremont
country: United States
facility: Forest Investigative Site 40
state: California
city: Palm Springs
country: United States
facility: Forest Investigative Site
state: California
city: Pomona
country: United States
facility: Forest Investigative Site
state: California
city: Sacramento
country: United States
facility: Forest Investigative Site 55
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 11
state: California
city: Santa Monica
country: United States
facility: Forest Investigative Site
state: California
city: Spring Valley
country: United States
facility: Forest Investigative Site
state: California
city: Tustin
country: United States
facility: Forest Investigative Site 49
state: California
city: Walnut Creek
country: United States
facility: Forest Investigative Site 47
state: California
city: Golden
country: United States
facility: Forest Investigative Site 61
state: Colorado
city: Wheat Ridge
country: United States
facility: Forest Investigative Site
state: Colorado
city: Daytona Beach
country: United States
facility: Forest Investigative Site 3
state: Florida
city: DeLand
country: United States
facility: Forest Investigative Site 33
state: Florida
city: Hollywood
country: United States
facility: Forest Investigative Site 36
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 62
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 080
state: Florida
city: Miami
country: United States
facility: Forest Investigative Site 59
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 32
state: Florida
city: Pembroke Pines
country: United States
facility: Forest Investigative Site 081
state: Florida
city: Tamarac
country: United States
facility: Forest Investigative Site 2
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site 19
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 44
state: Georgia
city: Augusta
country: United States
facility: Forest Investigative Site 5
state: Georgia
city: Honolulu
country: United States
facility: Forest Investigative Site 56
state: Hawaii
city: Meridian
country: United States
facility: Forest Investigative Site 57
state: Idaho
city: Chicago
country: United States
facility: Forest Investigative Site 39
state: Illinois
city: Wichita
country: United States
facility: Forest Investigative Site 37
state: Kansas
city: Baltimore
country: United States
facility: Forest Investigative Site
state: Maryland
city: Baltimore
country: United States
facility: Forest Investigative Site 20
state: Maryland
city: Oxon Hill
country: United States
facility: Forest Investigative Site 50
state: Maryland
city: St. Clair Shores
country: United States
facility: Forest Investigative Site 21
state: Michigan
city: Kansas City
country: United States
facility: Forest Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site
state: Missouri
city: New Hyde Park
country: United States
facility: Forest Investigative Site
state: New York
city: New York
country: United States
facility: Forest Investigative Site
state: New York
city: Charlotte
country: United States
facility: Forest Investigative Site 7
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 45
state: North Carolina
city: Morehead City
country: United States
facility: Forest Investigative Site 24
state: North Carolina
city: Salisbury
country: United States
facility: Forest Investigative Site 26
state: North Carolina
city: Wilmington
country: United States
facility: Forest Investigative Site 18
state: North Carolina
city: Centerville
country: United States
facility: Forest Investigative Site 51
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 48
state: Ohio
city: Wadsworth
country: United States
facility: Forest Investigative Site 12
state: Ohio
city: Charleston
country: United States
facility: Forest Investigative Site 17
state: South Carolina
city: Columbia
country: United States
facility: Forest Investigative Site 46
state: South Carolina
city: North Charleston
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Simpsonville
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Forest Investigative Site 4
state: South Dakota
city: New Tazewell
country: United States
facility: Forest Investigative Site 10
state: Tennessee
city: Corpus Christi
country: United States
facility: Forest Investigative Site 52
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 28
state: Texas
city: Hurst
country: United States
facility: Forest Investigative Site 38
state: Texas
city: Salt Lake City
country: United States
facility: Forest Investigative Site 34
state: Utah
city: St. George
country: United States
facility: Forest Investigative Site
state: Utah
city: Norfolk
country: United States
facility: Forest Investigative Site
state: Virginia
city: Virginia Beach
country: United States
facility: Forest Investigative Site 31
state: Virginia
city: Ponce
country: Puerto Rico
facility: Forest Investigative Site 41
city: Salinas
country: Puerto Rico
facility: Forest Investigative Site 60
city: Santurce
country: Puerto Rico
facility: Forest Investigative Site 29
Study officials:
affiliation: Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.
name: John Shea, MS
role: STUDY_DIRECTOR
References: