A Randomized Open-label Study to Compare Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Patients With Type 2 Diabetes Mellitus That do Not Reach Adequate Glycemic Control on Their Current Sulfonylurea Monotherapy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain
研究概览
简要总结
This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is not sufficient to reach glycemic control.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of type 2 diabetes mellitus.
- •Contraindicated or intolerant to take metformin.
- •HbA1c of ≥ 7.0% and ≤ 8.5%
- •Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- •Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.
- •Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month
- •Patients taking sulfonylurea for longer than 5 years
- •History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •pregnancy
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Vildagliptin
Patients randomized to the vildagliptin group will receive 50mg vildagliptin once daily add-on to their current glimepiride monotherapy for 24 weeks. No dose titrations are permitted during the study.
干预措施: LAF237 (Drug)
Protaphane
Patients randomized to the Protaphane group will receive a individualized dose of Protaphane once daily as bedtime dose. The Protaphane dose will be titrated within the first 4 weeks to reach fasting plasma glucose values below 100 mg/dl.
干预措施: Protaphane (Drug)
结局指标
主要结局
Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain
时间窗: 24 weeks
Primary endpoint is proportion of patients reaching the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement \< 3.9mM (71mg/dL)) and weight gain.
Rate of confirmed hypoglycemic events
时间窗: 24 weeks
Co-primary endpoint is to evaluate the rate of confirmed hypoglycemic events (BG measurement \< 3.9mM (71mg/dL)) in type 2 diabetes patients treated with vildagliptin versus NPH insulin add-on to glimepiride.
次要结局
- Incidence of severe hypoglycemic events(24 weeks)
- Incidence of symptomatic hypoglycemic events(24 weeks)
- Change from baseline in body weight at 24 weeks(Baseline, 24 week)
- Change from baseline in HbA1c at 24 weeks(Baseline, 24 week)
- Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) at 24 week(Baseline, 24 week)
- Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event(24 weeks)