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

Condition(s) targeted: Hypertension

Intervention: carvedilol (Drug); metoprolol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

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

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

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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 levels (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).

- 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.

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Starting date: June 2001
Last updated: April 13, 2015