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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
History of Changes
Results First Received: June 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Hypertension
Type 2 Diabetes Mellitus
Interventions: Drug: Nebivolol
Drug: Metoprolol ER
Drug: HCTZ

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occured from September 2008 through December 2009 at 69 US sites

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Placebo washout phase was required for patients currently on any anti-hypertensives at screening exclusive of background ACE inhibitor or ARB before assignment to HCTZ or Metoprolol ER or Nebivolol arms.

Reporting Groups
  Description
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
  • Open-label amlodipine may be given
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
  • Open-label amlodipine may be given
Hydrochlorothiazide (HCTZ)
  • 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

Participant Flow:   Overall Study
    Nebivolol     Metoprolol ER     Hydrochlorothiazide (HCTZ)  
STARTED     83     73     74  
COMPLETED     56     46     59  
NOT COMPLETED     27     27     15  
Lack of Efficacy                 1                 1                 0  
Withdrawal by Subject                 9                 5                 3  
Lost to Follow-up                 1                 1                 1  
Protocol Violation                 3                 4                 3  
Inclusion/Exclusion criteria not met                 1                 0                 0  
Dosing Error                 1                 0                 1  
Study Drug Error                 1                 0                 0  
Prohibited Concomitant Medication                 0                 0                 1  
Poor Compliance                 0                 2                 0  
Administrative. Site Closed                 1                 1                 1  
Adverse Event                 9                 13                 5  



  Baseline Characteristics
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Reporting Groups
  Description
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
  • Open-label amlodipine may be given
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
  • Open-label amlodipine may be given
Hydrochlorothiazide (HCTZ)
  • 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
Total Total of all reporting groups

Baseline Measures
    Nebivolol     Metoprolol ER     Hydrochlorothiazide (HCTZ)     Total  
Number of Participants  
[units: participants]
 		  83     73     74     230  
Age  
[units: years]
Mean ± Standard Deviation 		  58.2  ± 9.3     59.2  ± 8.3     59.5  ± 9.0     58.9  ± 8.9  
Age, Customized  
[units: participants]
 		       
Patients 18 to 64 years of age     61     51     53     165  
Patients greater than or equal to 65 years of age.     22     22     21     65  
Gender  
[units: participants]
 		       
Female     30     30     29     89  
Male     53     43     45     141  
Region of Enrollment  
[units: participants]
 		       
United States     78     69     72     219  
Puerto Rico     5     4     2     11  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26   [ Time Frame: visit 5(week 0) and visit 14(week 26) ]
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2.  Secondary:   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)] ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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