Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients
Condition: Hypertension; Type 2 Diabetes Mellitus
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Nebivolol; Metoprolol ER; HCTZ
Intervention description: 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; 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; HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: nebivolol; Bystolic ™; Hypertension; Diabetes

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