PER-174-08已完成未知
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2009年2月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 年龄范围
- 21 至 70（—）
入选标准
- •The patient has type 2 diabetes (T2DM).
- •The patient is> 21 and ^ 0 years old on the day of signing the informed consent.
- •The patient has a body mass index (BMI)> 20 kg / m ^ 2 and <43 kg / m ^ 2
- •The patient is currently undergoing therapy with LANTUS® insulin alone at a stable dose of> 15 units / day for at least 6 weeks and has an A1C level> 7.5% and <11.0% on Visit 1 / Selection visit.
- •The patient is a man or a woman with a high probability of conceiving
- •The patient understands the study procedures, the available alternative treatments, and the risks involved with the study, and agrees to voluntarily participate in the study by giving informed written consent.
- •The patient has an A1C level> 7.5% and <11.0%.
- •The patient has> 85% compliance during the transition period with placebo in simple blind (determined by the tablet count performed on site).
排除标准
- •The patient has a history of type 1 diabetes mellitus or a history of ketoacidosis, or the patient is evaluated by the investigator as possibly with type 1 diabetes confirmed with a C-peptide level <0.7 ng / mL (0.23 nmol / L).
- •The patient received more than 1 week of administration of doses of TZD therapy (eg, pioglitazone or rosiglitazone) or injectable therapy based on incretins (eg, Byetta®) within the previous 8 weeks.
- •The patient has a history of severe hypoglycemia defined as two or more episodes throughout his life or an episode within the last year that resulted in hypoglycemic attacks and / or brain disorder (eg, coma, severe confusion, etc.) or the patient has had asymptomatic hypoglycemia (i.e. glucose obtained by digital puncture <50 mg / dL [2.8 mmol / L] without symptoms) within the last 3 months.
- •Hypersensitivity or contraindication to receive LANTUS® insulin.
- •The patient is under a weight loss program and is not in the maintenance phase, or the patient is taking a weight loss drug (eg, orlistat, sibutramine, rimonabant, etc.) within 8 weeks of Visit 1 / Selection Visit.
- •The patient is currently participating, or has participated in a study with a compound or device under investigation within 3 months of signing the informed consent and is not willing to refrain from participating in another study for 3 months after completing this study.
- •The patient is under treatment, or is likely to require treatment, with warfarin or anticoagulants similar to warfarin, digoxin, or any other drug with a narrow therapeutic index (Refer to Appendix 6.3).
- •The patient is under treatment, or is likely to require treatment, of> 14 consecutive days or repeated cycles of pharmacological doses of systemic corticosteroids (oral, injectable / parenteral) or ocular during the study.
- •The patient has undergone surgery within 30 days prior to Visit 1 / Selection Visit or has planned major surgery.
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