Skip to main content
OpenTrials
Completed

NCT Number: NCT00744237

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Forest Investigative Site 41, Ponce, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nebivolol

Drug
  • 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 names: Bystolic (TM)

Metoprolol ER

Drug
  • 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

Drug
  • HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
  • HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration

Other names: Hydrochlorothorazide

Primary outcomes

  1. Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26

    Time frame: visit 5(week 0) and visit 14(week 26)

    Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.

Secondary outcomes

  1. 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)]

    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

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
First posted
Aug 29, 2008
Registry last updated
Jul 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.