Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Safety of vildagliptin in combination with pioglitazone during 52 weeks of treatment
研究概览
简要总结
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients successfully completing study CLAF237A2304 are eligible
- •Written informed consent
- •Ability to comply with all study requirements
排除标准
- •Premature discontinuation from study CLAF237A2304
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
vildagliptin 50 mg qd + pioglitazone 45 mg qd
vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks
干预措施: vildagliptin (Drug)
vildagliptin 50 mg qd + pioglitazone 45 mg qd
vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks
干预措施: pioglitazone (Drug)
vildagliptin 50 mg bd+ pioglitazone 45 mg qd
vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks
干预措施: vildagliptin (Drug)
vildagliptin 50 mg bd+ pioglitazone 45 mg qd
vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks
干预措施: pioglitazone (Drug)
结局指标
主要结局
Safety of vildagliptin in combination with pioglitazone during 52 weeks of treatment
Change from baseline in HbA1c at 52 weeks
次要结局
- Change from baseline in HOMA IR at 52 weeks
- Change from baseline in HOMA B at 52 weeks
- Change in HbA1c between 24 weeks and 52 weeks
- Change from baseline in fasting plasma glucose at 52 weeks
- Change in fasting plasma glucose between 24 weeks and 52 weeks