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

A Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients With Type II Diabetes Mellitus.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00060918
Enrollment
1210
Registered
2003-05-16
Start date
2001-06-30
Completion date
2004-04-30
Last updated
2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Type 2 diabetes, hypertension, beta-blockers

Brief summary

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.

Interventions

DRUGcarvedilol
DRUGmetoprolol

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change from baseline in HbA1c at 5 months5 months

Secondary

MeasureTime frame
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.5 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026