Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension - Full Text View

Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00060931

Purpose

Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure

Condition	Intervention	Phase
Non-Insulin-Dependent Diabetes Mellitus Hypertension	Drug: carvedilol Drug: metoprolol	Phase IV

MedlinePlus related topics:

Diabetes High Blood Pressure

ChemIDplus related topics:

Metoprolol Metoprolol fumarate Metoprolol succinate Metoprolol Tartrate Carvedilol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Multicenter Study Comparing the Effects of Carvedilol and Metoprolol on Glycemic Control in Hypertensive Patients With Type II Diabetes Mellitus.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline in HbA1c at 5 months [ Time Frame: 5 months ]

Secondary Outcome Measures:

Blood pressure at 3 and 5 months Body weight at 3 and 5 months Lab levels (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months. [ Time Frame: 5 months ]

Estimated Enrollment:	1210
Study Start Date:	May 2001

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Patients at screening must be insulin producing Type II diabetics (C peptide positive).
Patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure)
Patients must be on a stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
Patients must be on stable antidiabetic regimen (drug treated or diet alone).
Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).

Exclusion criteria:

Patients using beta-blocker therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060931

Show 108 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, M.D.	GlaxoSmithKline

More Information

Study ID Numbers:	105517/347
First Received:	May 15, 2003
Last Updated:	June 12, 2007
ClinicalTrials.gov Identifier:	NCT00060931
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Type 2 diabetes

hypertension

beta-blockers

Study placed in the following topic categories:

Metabolic Diseases

Metoprolol succinate

Diabetes Mellitus, Type 2

Vascular Diseases

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metoprolol

Metabolic disorder

Glucose Metabolism Disorders

Carvedilol

Hypertension

Additional relevant MeSH terms:

Vasodilator Agents

Neurotransmitter Agents

Sympatholytics

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Adrenergic alpha-Antagonists

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Adrenergic beta-Antagonists

Cardiovascular Diseases

Adrenergic Antagonists

Peripheral Nervous System Agents

Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on September 05, 2008