EUCTR2015-005101-36-BG进行中（未招募）1 期
A 24-Week, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-Naive Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,840
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
- •-Adult patients with type 2 diabetes mellitus (T2DM) inadequately controlled with OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months.
- •-Signed written informed consent.
- •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 1380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 460
排除标准
- •-Age <18 years.
- •-HbA1c <7.5% or >10.5% (at screening visit).
- •-Body mass index (BMI) <25 kg/m^2 or >40 kg/m^2.
- •-History of T2DM for less than 1 year before screening.
- •-Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if taken).
- •-Current or previous insulin use except for a maximum of 8 consecutive days or totally 15 days (eg, acute illness, surgery) during the last year prior to screening.
- •-Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
- •-Patient receiving only noninsulin antihyperglycemic drugs not approved for combination with insulin according to local labelling/local treatment guideline.
- •-History of hypoglycemia unawareness or repeated episodes of severe hypoglycemia or metabolic acidosis, including hospitalization for diabetic ketoacidosis during the last 12 months prior to screening.
- •-Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period.
- •-End stage renal disease.
- •-Any acute or chronic condition that in the opinion of Investigator would affect the patient safety, compliance, or study results.
- •-Any contraindication to use of Toujeo® or Tresiba® as defined in the national product label, hypersensitivity to Toujeo® or Tresiba® active ingredients or one of the excipients.
- •-Pregnant or breast-feeding women
研究者
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