Hypertension Clinical Trial
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
| NCT number | NCT00744237 |
| Other study ID # | NEB-MD-19 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | August 27, 2008 |
| Last updated | June 30, 2011 |
| Start date | August 2008 |
| Verified date | June 2011 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 231 |
| Est. completion date | |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Forest Investigative Site 41 | Ponce | |
| Puerto Rico | Forest Investigative Site 60 | Salinas | |
| Puerto Rico | Forest Investigative Site 29 | Santurce | |
| United States | Forest Investigative Site 15 | Athens | Alabama |
| United States | Forest Investigative Site 44 | Atlanta | Georgia |
| United States | Forest Investigative Site 5 | Augusta | Georgia |
| United States | Forest Investigative Site | Baltimore | Maryland |
| United States | Forest Investigative Site 20 | Baltimore | Maryland |
| United States | Forest Investigative Site 35 | Bell Gardens | California |
| United States | Forest Investigative Site | Buena Park | California |
| United States | Forest Investigative Site 51 | Centerville | Ohio |
| United States | Forest Investigative Site 17 | Charleston | South Carolina |
| United States | Forest Investigative Site 45 | Charlotte | North Carolina |
| United States | Forest Investigative Site 7 | Charlotte | North Carolina |
| United States | Forest Investigative Site 39 | Chicago | Illinois |
| United States | Forest Investigative Site 54 | Chino | California |
| United States | Forest Investigative Site 48 | Cincinnati | Ohio |
| United States | Forest Investigative Site 46 | Columbia | South Carolina |
| United States | Forest Investigative Site 52 | Corpus Christi | Texas |
| United States | Forest Investigative Site 28 | Dallas | Texas |
| United States | Forest Investigative Site 3 | Daytona Beach | Florida |
| United States | Forest Investigative Site 33 | DeLand | Florida |
| United States | Forest Investigative Site 40 | Fremont | California |
| United States | Forest Investigative Site 61 | Golden | Colorado |
| United States | Forest Investigative Site 36 | Hollywood | Florida |
| United States | Forest Investigative Site 56 | Honolulu | Hawaii |
| United States | Forest Investigative Site 16 | Huntsville | Alabama |
| United States | Forest Investigative Site 38 | Hurst | Texas |
| United States | Forest Investigative Site | Kansas City | Missouri |
| United States | Forest Investigative Site 57 | Meridian | Idaho |
| United States | Forest Investigative Site 080 | Miami | Florida |
| United States | Forest Investigative Site 59 | Miami | Florida |
| United States | Forest Investigative Site 62 | Miami | Florida |
| United States | Forest Investigative Site 24 | Morehead City | North Carolina |
| United States | Forest Investigative Site | New Hyde Park | New York |
| United States | Forest Investigative Site 10 | New Tazewell | Tennessee |
| United States | Forest Investigative Site | New York | New York |
| United States | Forest Investigative Site | Norfolk | Virginia |
| United States | Forest Investigative Site | North Charleston | South Carolina |
| United States | Forest Investigative Site 50 | Oxon Hill | Maryland |
| United States | Forest Investigative Site | Palm Springs | California |
| United States | Forest Investigative Site 081 | Pembroke Pines | Florida |
| United States | Forest Investigative Site 32 | Pembroke Pines | Florida |
| United States | Forest Investigative Site | Pomona | California |
| United States | Forest Investigative Site 55 | Sacramento | California |
| United States | Forest Investigative Site 26 | Salisbury | North Carolina |
| United States | Forest Investigative Site 34 | Salt Lake City | Utah |
| United States | Forest Investigative Site 11 | San Diego | California |
| United States | Forest Investigative Site | Santa Monica | California |
| United States | Forest Investigative Site | Simpsonville | South Carolina |
| United States | Forest Investigative Site 4 | Sioux Falls | South Dakota |
| United States | Forest Investigative Site | Spring Valley | California |
| United States | Forest Investigative Site 21 | St. Clair Shores | Michigan |
| United States | Forest Investigative Site | St. George | Utah |
| United States | Forest Investigative Site | St. Louis | Missouri |
| United States | Forest Investigative Site 2 | Tamarac | Florida |
| United States | Forest Investigative Site | Tampa | Florida |
| United States | Forest Investigative Site 49 | Tustin | California |
| United States | Forest Investigative Site 31 | Virginia Beach | Virginia |
| United States | Forest Investigative Site 12 | Wadsworth | Ohio |
| United States | Forest Investigative Site 47 | Walnut Creek | California |
| United States | Forest Investigative Site 19 | West Palm Beach | Florida |
| United States | Forest Investigative Site | Wheat Ridge | Colorado |
| United States | Forest Investigative Site 37 | Wichita | Kansas |
| United States | Forest Investigative Site 18 | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Secondary | Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 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 | [visit 5(week 0) and visit 14(week 26)] | No |
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