A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating and Maintaining Lantus® (Insulin Glargine) Therapy Based on a Comparison of Two Treatment Algorithms to Determine Optimal Metabolic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus.

Sanofi0 个研究点目标入组 7,376 人开始时间: 2002年3月最近更新: 2010年8月31日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Sanofi
入组人数: 7,376
主要终点: Incidence of severe hypoglycaemia

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Primary objective:

To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia.

Secondary objectives:

To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia.
To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms.
To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment.
To obtain safety data on the use of insulin glargine in each treatment algorithm.
To measure change in subject weight and insulin dose between baseline and end of treatment.
To determine subject quality of life and treatment satisfaction (sub-study)

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

未提供

排除标准

未提供

结局指标

主要结局

Incidence of severe hypoglycaemia

次要结局

Incidence of any hypoglycaemia
Incidence of nocturnal hypoglycaemia
Incidence of asymptomatic hypoglycaemia
Adjusted mean change in Hb1Ac (%)
Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
Incidence of symptomatic hypoglycaemia
Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
% of subjects at v12 with Hb1Ac < or = 6.5 %
% of subjects at v12 with Hb1Ac < or = 7.0 %
% of subjects at v12 with FBG < or = 100 mg/dl
Weight change (kg)
Change in insulin glargine dose v2 - v12 (IU)
Safety data
Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire

研究者

发起方

Sanofi

申办方类型

Industry

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