Study of the Glycemic Effects of Nebivolol Compared With... | NCT00744237

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	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
2	Active Comparator	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
3	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	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

Eligibility Module

Name	Affiliation	Role
John Shea, MS	Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Forest Investigative Site 15		Athens	Alabama	35611	United States
Forest Investigative Site 16

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	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
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00058.2± 9.3 BG00159.2± 8.3 BG00259.5± 9.0 BG003

Age, Customized

Number

participants

Title

Denominators

Categories

Patients 18 to 64 years of age

Title	Measurements
	BG00061 BG00151 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00030 BG00130 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00078 BG00169 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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

Posted

Mean

Standard Deviation

Percentage

visit 5(week 0) and visit 14(week 26)

ID	Title	Description
OG000	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
OG001	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
OG002	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

Units	Counts
Participants	OG00077 OG00169 OG00268

Title

Denominators

Categories

Title	Measurements
	OG0000.12± 0.78 OG0010.00± 0.65 OG0020.40± 0.96

Secondary

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

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

Posted

Mean

Standard Deviation

Unit on a scale

[visit 5(week 0) and visit 14(week 26)]

ID	Title	Description
OG000	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
OG001	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
OG002	Hydrochlorothiazide (HCTZ)

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	2	83	19	83
EG001	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	3	73	17	73
EG002	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	2	74	17	74

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected73 at risk EG0021 affected74 at risk
Arrhythmia	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected73 at risk EG0020 affected74 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 affected83 at risk EG0010 affected73 at risk EG0021 affected74 at risk
Cardiomegaly	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected73 at risk EG0020 affected74 at risk
Deep vain thrombosis postoperative	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected73 at risk EG0020 affected74 at risk
Diverticulitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected83 at risk EG0010 affected73 at risk EG0020 affected74 at risk
Incision site cellulitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected73 at risk EG0020 affected74 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected73 at risk EG0020 affected74 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected73 at risk EG0020 affected74 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected73 at risk EG0020 affected74 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 affected83 at risk EG0011 affected73 at risk EG0020 affected74 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0006 affected83 at risk EG0018 affected73 at risk EG0020 affected74 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0003 affected83 at risk EG0016 affected73 at risk EG0021 affected74 at risk
Dizziness	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0005 affected83 at risk EG0013 affected73 at risk EG0023 affected74 at risk
Fatigue	General disorders	MedDRA (11.1)	Systematic Assessment	EG0003 affected83 at risk EG0011 affected73 at risk EG0025 affected74 at risk
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0005 affected83 at risk EG0017 affected73 at risk EG0025 affected74 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected83 at risk EG0011 affected73 at risk EG0025 affected74 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected83 at risk EG0014 affected73 at risk EG0023 affected74 at risk
Oedema peripheral	General disorders	MedDRA (11.1)	Systematic Assessment	EG0008 affected83 at risk EG0017 affected73 at risk EG0026 affected74 at risk
Upper Resiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected83 at risk EG0011 affected73 at risk EG0025 affected74 at risk

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D050198	Phenoxypropanolamines
D011412	Propanolamines
D020005	Propanols
D002740	Chlorothiazide
D001581	Benzothiadiazines
D013449	Sulfonamides
D013450	Sulfones
D013457	Sulfur Compounds
D049971	Thiazides

ID	Term
D006973	Hypertension
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D000068577	Nebivolol
D008790	Metoprolol
D006852	Hydrochlorothiazide