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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00744237
First received: August 27, 2008
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Hypertension
Type 2 Diabetes Mellitus
Drug: Nebivolol
Drug: Metoprolol ER
Drug: HCTZ
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26 [ Time Frame: visit 5(week 0) and visit 14(week 26) ] [ Designated as safety issue: No ]
    Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.


Secondary Outcome Measures:
  • Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: [visit 5(week 0) and visit 14(week 26)] ] [ Designated as safety issue: No ]
    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


Enrollment: 231
Study Start Date: August 2008
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Nebivolol
  • 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
Other Name: Bystolic (TM)
Active Comparator: 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
Drug: Metoprolol ER
  • 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
Active Comparator: 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
Drug: HCTZ
  • HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
  • HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Other Name: Hydrochlorothorazide

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744237

  Show 65 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: John Shea, MS Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.
  More Information

No publications provided

Responsible Party: John Whalen, MD, Executive Director, Clinical Development, Cardiovascular, Forest Research Institute, a Subsidiary of Forest Laboratories Inc.
ClinicalTrials.gov Identifier: NCT00744237     History of Changes
Other Study ID Numbers: NEB-MD-19
Study First Received: August 27, 2008
Results First Received: June 30, 2011
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
nebivolol
Bystolic ™
Hypertension
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Metoprolol
Metoprolol succinate
Nebivolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 29, 2014