NCT00525330已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- The primary objective of this trial is to demonstrate the hemoglobin A1c (HbA1c)-lowering effects of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone.
研究概览
简要总结
To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor, in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how much of the HbA1c response is attributable to nocturnal coverage will be explored.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years, inclusive;
- •Males and females of non-childbearing potential;
- •Diagnosis of type 2 diabetes mellitus according; and
- •On a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry
排除标准
- •History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
- •History or presence of alcoholism or drug abuse
- •Typical consumption of ≥10 drinks of alcohol weekly;
- •Presence of any of the following conditions:
- •Significant renal impairment (glomerular filtration rate <60 mL/min [to be calculated by the central laboratory]);
- •Diabetic retinopathy;
- •Diabetic gastroparesis;
- •Active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;
- •Uncontrolled high blood pressure;
- •History or evidence of cardiovascular or pulmonary disease
- •Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals
结局指标
主要结局
The primary objective of this trial is to demonstrate the hemoglobin A1c (HbA1c)-lowering effects of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone.
时间窗: 12-weeks
次要结局
- To assess the fasting plasma glucose (FPG)-lowering effect of KRP-104 in patients with type 2 diabetes inadequately controlled on metformin alone;(12-weeks)
- To compare effects of once daily (QD) dosing versus twice daily (BID) dosing of KRP-104 on HbA1c and FPG(12 weeks)
- To assess the effects of KRP-104 on post-prandial glucose dynamics and insulin sensitivity (homeostasis model index [HOMA-β]) in the setting of a Meal Tolerance Test(MTT)(12 weeks)
- To assess the safety and tolerability of KRP-104;(Daily for 12 weeks to 2 weeks post-treatment)
研究者
研究点 (1)
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