EUCTR2012-003941-13-DE进行中（未招募）不适用
A Comparison of LY2605541 versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients with Type 2 Diabetes Mellitus not Adequately Controlled with 2 or more Oral Antihyperglycemic Medications: An Open-Label, Randomized Study. - The IMAGINE 6 Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 630
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have had T2DM for at least 1 year not treated with insulin
- •Are 18 years of age or older
- •Have been receiving 2 or more OAMs for at least 3 months prior to the study
- •Have HbA1c of 7.0% to 11.0%
- •Have BMI =45.0% kg/m2
- •Are willing and able to inject insulin and perform self-monitoring blood glucose
- •Have given written informed consent to participate in this study
- •Are not pregnant or breastfeeding (only applies to females of child-bearing potential)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 470
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Have used insulin therapy in the past 2 years
- •Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months of Visit 1.
- •Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to Visit 1.
研究者
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