NCT00494884已完成3 期
A Multicenter, Randomized, Double-blind, Parallel-group Study to Investigate the Glucose Lowering Effect, Safety and Tolerability of 24 Weeks Treatment With Vildagliptin 100 mg o.d. Versus Placebo Followed by a 12 Weeks Treatment Period With Open-label Vildagliptin 100 mg o.d. as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 试验地点
- 1
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.
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
- Double
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
- •Male, non-fertile female or female of childbearing potential using a medically approved birth control method
- •Patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
- •Agreement to maintain the same dose of metformin throughout the study
- •Age in the range of 18-85 years inclusive.
- •HbA1c in the range of 6.5 - 8.0% (inclusive) at visit 1
- •Agreement to maintain prior diet and exercise habits during the full course of the study
- •Ability to comply with all study requirements and signed informed consent to participate in the study.
排除标准
- •Pregnant or lactating female
- •A history of:
- •type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
- •acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
- •Any of the following significant laboratory abnormalities:
- •ALT, AST greater than 2 times the upper limit of the normal range at visit
- •Direct bilirubin greater than the upper limit of the normal range at visit
- •Serum creatinine levels equal to or greater than 1.5 mg/dL (132 umol/L) males, equal to or greater than 1.4 mg/dL (123 umol/L) females, or a history of abnormal creatinine clearance at visit
- •Clinically significant TSH values outside of normal range at visit
- •Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Change from baseline in HbA1c
时间窗: 24 weeks
次要结局
- Responder rates(24 weeks)
- Change in systolic and diastolic blood pressure(24 weeks)
- Change from baseline in fasting plasma glucose(24 weeks)
- Adverse event profiles including gastrointestinal tolerability and hypoglycemia(24 weeks)
- Change from baseline in insulin and proinsulin in a subgroup of patients(24 weeks)
研究者
研究点 (1)
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