Conditions: Hypertension Type 2 Diabetes Mellitus
Keywords: nebivolol Bystolic ™ Hypertension Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 231
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: * 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 arm 2: * 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 arm 3: * 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

Interventions: intervention 1: Nebivolol intervention 2: Metoprolol ER intervention 3: HCTZ
Intervention descriptions: intervention 1: * 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 intervention 2: * 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 intervention 3: * HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
* HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration

Protocol document: