CTRI/2022/05/042581已完成4 期
A Phase IV, prospective, single arm, baseline controlled, multi-centric study for assessment of safety and efficacy of Fixed dose combination (FDC) of Remogliflozin Etabonate, Metformin and Vildagliptin (RMV) in management of Type 2 Diabetes Mellitus (T2DM) patients
Glenmark Pharmaceuticals Ltd9 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2022年5月20日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 9
- 主要终点
- Incidence of related TEAEs of special interest as assessed by physician
研究概览
简要总结
This study is being conducted to assess safety and efficacy of Remogliflozin+Metformin+Vildagliptin FDC on patients with T2DM. This study is a Prospective, single arm, baseline controlled, multi-centric study. It will be conducted on 215 patients across approx. 9 centres in India. All enrolled patients will be followed up for a period of 24 weeks. AEs, TEAEs will be evaluated during the entire study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult Indian (Age ≥18 years, ≤ 65 years) of either gender, diagnosed with T2DM for more than 6 months
- •On ongoing dual drug regimen of stable dose of Metformin+DPP4i or Metformin+SGLT2i since last 12 weeks before screening
- •With Daily Metformin Dose on 1000mg or 2000mg
- •Uncontrolled glycaemia with HbA1c ≥ 8% at time of screening
- •Patient willing to provide signed and dated, written informed consent prior to any study specific procedures.
排除标准
- •H/o hypersensitivity or contraindication to the contents of the IP, (Remogliflozin Etabonate, Vildagliptin and Metformin)
- •Patients of Type 1 diabetes.
- •Patient suffering from any moderate to severe hepatic, cardiac, neurologic or neoplastic disorder
- •Patients with eGFR <60 mL/min/1.73 m2 at time of initiation of Remogliflozin Etabonate (RE) therapy (eGFR of <45 L/min/1.73m2 in patients on Metformin+RE)
- •History of pancreatitis or pancreatic surgery
- •Patients with a history of any malignancy
- •History of diabetic ketoacidosis
- •Any acute/chronic systemic infections
- •Patients at risk for volume depletion as judged by the investigator
- •Active participation in another clinical study with IP and/or investigational device
- •For women only – currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
- •Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance.
结局指标
主要结局
Incidence of related TEAEs of special interest as assessed by physician
时间窗: Up to Week 24
次要结局
- 1. Mean change from baseline in HbA1c levels at Week 24(2. Mean change from baseline in HbA1c levels at Week 12)
研究者
研究点 (9)
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