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

This study has been completed.

First Received: May 15, 2003 Last Updated: May 21, 2009 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:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes 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

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 111 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, M.D.

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	105517/346
Study First Received:	May 15, 2003
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00060918 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Type 2 diabetes
hypertension
beta-blockers

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Carvedilol
Sympatholytics
Metabolic Diseases
Vascular Diseases
Diabetes Mellitus

Endocrine System Diseases
Adrenergic alpha-Antagonists
Cardiovascular Agents
Metoprolol
Antihypertensive Agents
Pharmacologic Actions
Autonomic Agents
Metoprolol succinate
Diabetes Mellitus, Type 2
Adrenergic Antagonists
Peripheral Nervous System Agents
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on November 22, 2009