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

Phase 4

Completed

Conditions: Hypertension
Type 2 Diabetes Mellitus

Interventions: Drug: Metoprolol ER
Drug: Nebivolol
Drug: HCTZ

Registration Number: NCT00744237

Lead Sponsor: Forest Laboratories

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: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 231

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	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
1	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
3	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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26	visit 5(week 0) and visit 14(week 26)	Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	[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

Trial Locations

Locations (50): Forest Investigative Site 49
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Tustin, California, United States
Forest Investigative Site 32
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Pembroke Pines, Florida, United States
Forest Investigative Site 081
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Pembroke Pines, Florida, United States
Forest Investigative Site 39
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Chicago, Illinois, United States
Forest Investigative Site 20
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Baltimore, Maryland, United States
Forest Investigative Site 50
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Oxon Hill, Maryland, United States
Forest Investigative Site 37
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Wichita, Kansas, United States
Forest Investigative Site 61
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Golden, Colorado, United States
Forest Investigative Site 11
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San Diego, California, United States
Forest Investigative Site 62
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Miami, Florida, United States
Forest Investigative Site 080
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Miami, Florida, United States
Forest Investigative Site 59
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Miami, Florida, United States
Forest Investigative Site 48
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Cincinnati, Ohio, United States
Forest Investigative Site 34
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Salt Lake City, Utah, United States
Forest Investigative Site 15
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Athens, Alabama, United States
Forest Investigative Site 40
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Fremont, California, United States
Forest Investigative Site
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Norfolk, Virginia, United States
Forest Investigative Site 33
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DeLand, Florida, United States
Forest Investigative Site 3
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Daytona Beach, Florida, United States
Forest Investigative Site 56
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Honolulu, Hawaii, United States
Forest Investigative Site 5
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Augusta, Georgia, United States
Forest Investigative Site 2
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Tamarac, Florida, United States
Forest Investigative Site 19
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West Palm Beach, Florida, United States
Forest Investigative Site 21
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St. Clair Shores, Michigan, United States
Forest Investigative Site 57
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Meridian, Idaho, United States
Forest Investigative Site 7
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Charlotte, North Carolina, United States
Forest Investigative Site 45
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Charlotte, North Carolina, United States
Forest Investigative Site 26
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Salisbury, North Carolina, United States
Forest Investigative Site 51
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Centerville, Ohio, United States
Forest Investigative Site 46
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Columbia, South Carolina, United States
Forest Investigative Site 10
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New Tazewell, Tennessee, United States
Forest Investigative Site 4
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Sioux Falls, South Dakota, United States
Forest Investigative Site 41
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Ponce, Puerto Rico
Forest Investigative Site 29
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Santurce, Puerto Rico
Forest Investigative Site 28
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Dallas, Texas, United States
Forest Investigative Site 38
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Hurst, Texas, United States
Forest Investigative Site 60
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Salinas, Puerto Rico
Forest Investigative Site 16
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Huntsville, Alabama, United States
Forest Investigative Site 12
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Wadsworth, Ohio, United States
Forest Investigative Site 47
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Walnut Creek, California, United States
Forest Investigative Site 35
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Bell Gardens, California, United States
Forest Investigative Site 31
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Virginia Beach, Virginia, United States
Forest Investigative Site 36
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Hollywood, Florida, United States
Forest Investigative Site 18
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Wilmington, North Carolina, United States
Forest Investigative Site 54
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Chino, California, United States
Forest Investigative Site 44
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Atlanta, Georgia, United States
Forest Investigative Site 24
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Morehead City, North Carolina, United States
Forest Investigative Site 52
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Corpus Christi, Texas, United States
Forest Investigative Site 55
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Sacramento, California, United States
Forest Investigative Site 17
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Charleston, South Carolina, United States