PER-078-14已完成未知
A randomized, open-label, 2-arm parallel-group, multicenter, 26-week study assessing the safety and efficacy of HOE901-U300 versus Lantus in older patients with type 2 diabetes inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
Sanofi Aventis Recherche & Development,0 个研究点目标入组 71 人开始时间: 2015年5月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 71
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
- 65 至 100（—）
- 性别
- All
入选标准
- •- Patients ≥ 65 years old with type 2 diabetes mellitus, inadequately controlled on pharmacologic antidiabetic regimens either including no insulin, or with basal insulin as their only insulin; and
- •- Signed informed consent
排除标准
- •HbA1c at screening visit:
- •- < 7.0% or > 10.0% for patients taking basal insulin,
- •- < 7.5% or > 11.0% for insulin-naïve patients.
- •Patients not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit); Change in dose of non-insulin antidiabetic treatment or initiation of new glucose-lowering medications in the
- •last 8 weeks prior to screening.
- •Chronic (> 10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, eg, premix insulin; For insulin-naïve
- •individuals.
- •Cognitive disorder and dementia assessed clinically and by Mini– Mental State Examination (MMSE) score <24, or any neurologic disorder that will likely affect the patient’s ability to follow the study procedure.
- •Patients who have end-stage renal disease (<15 mL/min/1.73m2, per estimated Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease [MDRD]).
研究者
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