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

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

This study has been completed.

Study NCT00060931. Last updated on October 15, 2008. Information provided by GlaxoSmithKline

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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.

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Non-Insulin-Dependent Diabetes Mellitus
Hypertension

Intervention ^†

Drug: carvedilol
Drug: metoprolol

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

1210

Start Date ^†

June 2001

Completion Date

Eligibility 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.

Gender

Both

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00060931

Organization ID

105517/347

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, M.D.

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

First Received Date ^†

May 15, 2003

Last Updated Date

October 15, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.