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

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Hypertension; Type 2 Diabetes Mellitus

Treatments: Drug: HCTZ; Drug: Metoprolol ER; Drug: Nebivolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00744237

NEB-MD-19

Details and patient eligibility

About

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

Enrollment: 231 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

231 participants in 3 patient groups

1

Experimental group

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 * Open-label amlodipine may be given

Treatment:

Drug: Nebivolol

2

Active Comparator group

Description:

* 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

Treatment:

Drug: Metoprolol ER

3

Active Comparator group

Description:

* 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

Treatment:

Drug: HCTZ