PER-041-03已完成1 期
MULTICENTRIC STUDY, IN PHASE 3, RANDOMIZED, DOUBLE BLIND, CONTROLLED WITH PLACEBO, TO EVALUATE THE SAFETY AND EFFICACY OF BMS-298585 IN COMBINATION WITH METFORMIN, FOR THE TREATMENT OF INDIVIDUALS WITH DIABETES TYPE 2 THAT PRESENT AN INAPPROPRIATE CONTROL WITH METFORMIN AS MONOTHERAPY.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Body Mass Index <41 kg / m2.
- •2) Patients with type 2 diabetes are eligible who have
- •required to be treated with metformin, in doses not less than 1500 mg nor
- •greater than 2550 mg during the last 6 weeks prior to selection.
- •3) HbAic> 7.0% and <10.0% obtained at the screening visit.
- •4) Fasting peptide c> 1.5 ng / mL.
- •5) average serum TG <600 mg / dL (6.78 mmol / L) obtained at the visit of
- •selection (in those patients with TG of> 600 and <1000 mg / dL,
- •can make a new determination).
排除标准
- •1) Symptomatic type 2 diabetes, defined by polyuria and poiidipsia with loss
- •weighing more than 10% during the last three months.
- •2) History of diabetic ketoacidosis, hyperosmolar non-ketotic coma, or insulin treatment within one year of selection.
- •3) Individuals who have contraindications to treatment as described
- •explained in the Instructions for the Researcher of BI \ / IS-298585 or in the package insert for metformin.
研究者
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