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

This study has been completed.

First Received on May 15, 2003. Last Updated on September 8, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00060918

Purpose

To evaluate the effects of two different antihypertensive medications in the drug class of beta-blockers 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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients With Type II Diabetes Mellitus.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 High Blood Pressure

Drug Information available for: Metoprolol Metoprolol Tartrate Carvedilol Metoprolol succinate Metoprolol fumarate

U.S. FDA Resources

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 values (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months. [ Time Frame: 5 months ]

Estimated Enrollment:	1210
Study Start Date:	June 2001

Intervention Details:

Other Names:

metoprolol
carvedilol

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).
Must have a history of mild to moderate hypertension (140-179 systolic; 90-1-9 diastolic).
Must be on stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).
Must be on a stable antidiabetic regimen (drug treated or diet alone).

Exclusion criteria:

Patients using beta-blocker therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060918

Show 110 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00060918 History of Changes
Other Study ID Numbers:	105517/346
Study First Received:	May 15, 2003
Last Updated:	September 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Type 2 diabetes
hypertension
beta-blockers

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Carvedilol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on February 09, 2012