临床试验/NCT00598793

NCT00598793已完成3 期

Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy

Novo Nordisk A/S28 个研究点分布在 1 个国家目标入组 242 人开始时间: 2002年11月最近更新: 2017年1月9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: 242
试验地点: 28
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). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.

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

入选标准

•Insulin naive Type 2 diabetes
•Currently treated with OADs alone or combined with other treatment for at least 3 months
•BMI below 40 kg/m2 and body weight below 125 kg
•HbA1c greater than or equal to 8%

排除标准

•Inability to tolerate metformin or contradictions to its use
•Pregnant, breastfeeding or intention of becoming pregnant
•Allergy to any of the trial products
•Inability or unwillingness to perform SMBG

结局指标

主要结局

HbA1c

时间窗: after 28 weeks of treatment

次要结局

Postprandial glucose by 8-point SMBG
Number of subjects achieving HbA1c below 7%
Number of hypoglycemic episodes and adverse events
Weight change
Insulin dose

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (28)

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