EUCTR2010-023769-23-FI进行中（未招募）不适用
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both plus Mealtime Insulin in Patients with Type 2 Diabetes Mellitus with a 6-month Safety Extension Period
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with type 2 diabetes mellitus
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Age <18 years;
- •HbA1c <7.0% or >10% at screening;
- •Diabetes other than type 2 diabetes mellitus;
- •Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose;
- •Any contraindication to use of insulin glargine as defined in the national product label;
- •Patients using human regular insulin as mealtime insulin in the last 3 months before screening visit;
- •Use of an insulin pump in the last 6 months before screening visit;
- •Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before
- •screening visit;
- •History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period;
- •Pregnant or breast-feeding women or women who intend to become pregnant during the study period.
研究者
相似试验
已完成
3 期
6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both plus Mealtime Insulin in Patients with Type 2 Diabetes Mellitus with a 6-month Safety Extension PeriodDiabetes Mellitus type 210018424NL-OMON39048Sanofi-aventis40
进行中（未招募）
不适用
Comparison of a new formulation of insulin glargine with Lantus in patients with type 2 diabetes mellitus on basal plus mealtime insuliMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2010-023769-23-SEsanofi-aventis recherche & développement800
进行中（未招募）
不适用
Comparison of a new formulation of insulin glargine with Lantus in patients with type 2 diabetes mellitus on basal plus mealtime insuliType 2 Diabetes MellitusEUCTR2010-023769-23-NLsanofi-aventis recherche & développement800
进行中（未招募）
不适用
Comparison of a new formulation of insulin glargine with Lantus in patients with type 2 diabetes on non-insulin antidiabetic therapyType 2 diabetes mellitusMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-000146-35-DKsanofi-aventis recherche & développement1,200
进行中（未招募）
不适用
Comparison of a new formulation of insulin glargine with Lantus in patients with type 2 diabetes on non-insulin antidiabetic therapyEUCTR2012-000146-35-FIsanofi-aventis recherche & développement1,200