临床试验/NCT00399711

NCT00399711已完成3 期

Repaglinide and Metformin Combination Tablet (NN4440) in a TID Regimen Compared to a BID Regimen and BID Avandamet in Subjects With Type 2 Diabetes: A Twenty-Six Week, Open-Label, Multicenter, Randomized, Parallel Group Trial to Investigate Efficacy and Safety

Novo Nordisk A/S103 个研究点分布在 1 个国家目标入组 560 人开始时间: 2006年11月1日最近更新: 2017年2月10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: 560
试验地点: 103
主要终点: HbA1c

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). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Type 2 diabetes for at least 3 months
•HbA1c between 7.5-11.0% on monotherapy or
•HbA1c between 7.0-10.0% on dual therapy
•BMI maximum 45 kg/m2

排除标准

•Any clinically significant disease history in the opinion of the investigator
•Severe heart disease
•Pregnancy

结局指标

主要结局

HbA1c

时间窗: After 26 weeks of treatment

次要结局

Change in 8-point Glucose Profiles
Change in Lipid Profile
Events of hypoglycemia
Safety parameters
Change in Fasting Plasma Glucose
Waist/hip ratio change
Change in body weight
Percentage of subjects achieving sudden levels of HbA1c

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (103)

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