EUCTR2016-001328-77-HU进行中（未招募）1 期
A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients with Type 2 Diabetes Mellitus
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
- 296
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
- •-Patients with type-2 diabetes mellitus (T2DM) for at least 3 months before the screening visit.
- •-On diet/exercise and/or treatment with metformin (stable dose of =1500 mg/day or maximal tolerated dose) for at least 3 months prior to screening.
- •-Signed 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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •-At screening, patient’s age < legal age of adulthood and >80 years.
- •-Glycated hemoglobin at screening visit <7.0% or >10.0%.
- •-Body mass index (BMI) <25 kg/m^2 or >45.0 kg/m^2.
- •-Pregnant or lactating women.
- •-Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
- •-Diagnosis of type 1 diabetes mellitus.
- •-Fasting plasma glucose of >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.
- •-Treatment with glucose-lowering agents(s) other than metformin, currently or within the 3 months prior to screening.
- •-Previous insulin use, except for episode(s) of short-term treatment (=15 consecutive days) for intercurrent illness or pregnancy, or use of insulin within the last 6 months.
- •-Contraindication(s) to metformin use.
- •-Contraindication(s) to liraglutide use.
- •-Significant change in body weight in the 3 months before screening.
- •-Poorly controlled hypertension (a resting systolic blood pressure [SBP] >160 mm Hg and/or diastolic blood pressure [DBP] >95 mm Hg at screening).
- •-History of long QT syndrome and/or QTc more than 450 ms at screening visit.
- •-History of pancreatitis or pancreatectomy.
- •-History of weight loss surgery.
- •-Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.
- •-Any prior exposure to drugs belonging to the class of glucagon-like peptide-1 (GLP-1) receptor agonists/GLP-1 analogs.
- •-Contraindications or known hypersensitivity reaction to glucagon.
研究者
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