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

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Primary Completion: 2010-07
• Status Verified: 2011-06
• Results First Submitted: 2011-06-30
• Results First Submitted QC: 2011-06-30
• Last Update Submitted: 2011-06-30
• Results First Posted: 2011-07-29
• Last Update Posted: 2011-07-29

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 15; 🇺🇸 Athens, Alabama, United States

Forest Investigative Site 16; 🇺🇸 Huntsville, Alabama, United States

Forest Investigative Site 35; 🇺🇸 Bell Gardens, California, United States

Forest Investigative Site; 🇺🇸 Norfolk, Virginia, United States

Forest Investigative Site 54; 🇺🇸 Chino, California, United States

Forest Investigative Site 40; 🇺🇸 Fremont, California, United States

Forest Investigative Site 55; 🇺🇸 Sacramento, California, United States

Forest Investigative Site 11; 🇺🇸 San Diego, California, United States

Forest Investigative Site 49; 🇺🇸 Tustin, California, United States

Forest Investigative Site 47; 🇺🇸 Walnut Creek, California, United States

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