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

Condition(s) targeted: Non-Insulin-Dependent Diabetes Mellitus; Hypertension

Intervention: carvedilol (Drug); metoprolol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, M.D., Study Director, Affiliation: GlaxoSmithKline

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.

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.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in HbA1c at 5 months

Secondary outcome: 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.

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

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.

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Starting date: May 2001
Last updated: June 12, 2007