CTRI/2024/11/076574尚未招募不适用
A Non-Interventional, Multi-center, Post approval, ObseRvatiOnal Study to Understand Safety and EffectiVEness of IMEglimin SR as Add on TreatmeNT in Indian T2DM Patients
Torrent Pharmaceuticals Ltd.1 个研究点 分布在 1 个国家目标入组 1,750 人开始时间: 2024年11月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,750
- 试验地点
- 1
- 主要终点
- 1. Mean change from baseline in HbA1c
研究概览
简要总结
Study design: Post approval, observational, single arm, multicentre study
**Objective:**To assess the Safety and Effectiveness of Imeglimin SR as an add on treatment in T2DM patients in India.
Duration of observation: 12 weeks
**Study population:**Uncontrolled T2DM patients with HbA1c 7-10 percent.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female T2DM patients 18 to 75 years.
- •T2DM cases with uncontrolled Hyperglycemia either with mono or dual or triple (as per discretion of physician) OADs or insulin and having HbA1c 7-10 percent.
排除标准
- •HbA1c greater than 10 percent
- •Clinical history of hypersensitivity or DKA
- •Clinical history of Active or uncontrolled ASCVD or Heart failure or Retinopathy or Neuropathy
- •Clinical history of CKD (eGFR less than 45 ml per min per m2).
结局指标
主要结局
1. Mean change from baseline in HbA1c
时间窗: 1. at week 12 | 2. from baseline at week 4 and week 12
2. Mean change in FPG, 2-hr PPBG
时间窗: 1. at week 12 | 2. from baseline at week 4 and week 12
次要结局
- Safety of Imeglimin SR(at week 4 and week 12)
- Mean change from baseline in HbA1c in patients with DPP4i/Met, SGLT2i/Met, SU/Met and/or insulin and/or GLP1a(at week 12)
- Change from baseline in HbA1c assessment for Overall and CV risk cases (with QRISK-3 score greater than 10 percent involving multiple risk factors, LVD, Stage 3a CKD, Age greater than or equal to 40y, Personal or Family History of ASCVD)(at week 12)
- Change from baseline in HbA1c assessment for cases with Young Onset Diabetes (Age 18 to 40y)(at week 12)
- Treatment responders with target HbA1c achievement of less than 7 percent in Overall, CV risk and YoD cases(at week 12)
- Changes in dose of baseline sulfonyl urea/insulin(at 4 and 12 weeks)
研究者
Dr Shrikant Somani
研究点 (1)
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