临床试验/NCT00060918

NCT00060918已完成4 期

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

GlaxoSmithKline51 个研究点分布在 1 个国家目标入组 1,210 人开始时间: 2001年6月1日最近更新: 2015年4月15日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 1,210
试验地点: 51
主要终点: Change from baseline in HbA1c at 5 months

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 30 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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).

排除标准

•Patients using beta-blocker therapy.

结局指标

主要结局

Change from baseline in HbA1c at 5 months

时间窗: 5 months

次要结局

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)

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (51)

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