临床试验/NCT00313001

NCT00313001已完成3 期

Effects of NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) BID and QD vs. Byetta™ Exenatide) BID on Glycemic Control: A Multicenter, 24-Week, Open-Label, Parallel Group Study in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets With Metformin and a Sulfonylurea

Novo Nordisk A/S2 个研究点分布在 1 个国家目标入组 373 人开始时间: 2006年4月最近更新: 2017年1月6日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 373
试验地点: 2
主要终点: Superiority as assessed by HbA1c reduction

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

This trial is conducted in the United States of America (USA). The study will compare A1C reduction achieved in patients receiving biphasic insulin aspart 70/30 once or twice daily to patients receiving exenatide twice daily. Patients enrolled in the study will be insulin naive patients who have not achieved glycemic control with metformin and sulfonylurea.

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: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 2 diabetes
•HbA1C: At least 8%
•Patients that were never treated with insulin before
•Current therapy with metformin and a sulfonylurea.

排除标准

•History of recurrent, severe hypoglycemia
•Hepatic insufficiency: ALT, AST or alkaline phosphatase > 2.5 times upper limits of laboratory's normal
•Renal insufficiency: serum creatinine > 1.3 mg/dL (males) or > 1.2 mg/dL (females)
•Severe gastrointestinal disease, including gastroparesis

结局指标

主要结局

Superiority as assessed by HbA1c reduction

时间窗: at 24 weeks

次要结局

Safety variables
Patient satisfaction

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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