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临床试验/CTRI/2025/02/079966
CTRI/2025/02/079966招募中4 期

A prospective, investigator initiated, interventional, single arm, open-label study to evaluate the efficacy and safety of Imeglimin using Continuous Glucose Monitoring (CGM) in Type 2 Diabetes Mellitus (T2DM) patients

Dr Unnikrishnan Ambika Gopalakrishnan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月17日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Glycemic Profile Assessment, based on pre- & post administration changes in the following parameters: [Time Frame: From Enrolment to EOS (Week 12)]

研究概览

简要总结

Type 2 diabetes mellitus (T2DM), the most common type of diabetes, is a chronic condition that occurs due to persistently high blood sugar (glucose) levels (hyperglycemia). Blood glucose obtained from food is the main source of energy and Insulin, (a hormone made by the beta cells of pancreas) helps glucose get into the fat, liver and muscle cells to be used for energy.

Imeglimin is a first-in-class novel oral antidiabetic drug used to treat T2DM targeting mitochondrial bioenergetics. It improves mitochondrial function by modulating mitochondrial respiratory chain complex activities while decreasing reactive oxygen species production. Imeglimin has been shown to amplify glucose-stimulated insulin secretion by improving β-cell glucose response in patients with T2DM and to improve insulin sensitivity in a rodent model of diabetes, allowing for normalization of glucose tolerance. More recent data suggest that imeglimin prevents the death of human endothelial cells by inhibiting opening of the mitochondrial permeability transition pore—a known cause of cell death—without inhibiting mitochondrial respiration this finding suggests the potential for end organ protection (e.g. kidney or heart)

The current study is an open-label, single-arm interventional trial initiated by the investigator to evaluate the efficacy and safety of Imeglyn® in patients with T2DM. Using CGM technology, the study will capture real-time data on glucose dynamics, such as postprandial spikes and hypoglycemic episodes. This approach aims to provide a deeper understanding of Imeglimin’s clinical benefits, offering insights beyond conventional glycemic measurements.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18-75 years
  • Patients diagnosed with T2DM for more than 180 days
  • Patients with T2DM, who had poor control of blood glucose levels (HbA1c 7-10.5%) in spite of diet and exercise therapy for 1 month or longer, with or without Oral Anti Diabetic Treatment (up to maximum of 3 OADs)
  • Patients / Legally Acceptable Representative who are willing to provide written informed consent.
  • Patients who are willing and able to comply with study procedures and follow-up assessments.

排除标准

  • 1.Patients Diagnosed with type 1 diabetes mellitus, maturityonset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycemic state other than T2DM.
  • Female patients who are pregnant, breastfeeding, or planning to become pregnant during the conduct of the study
  • Patients with history or presence of clinically significant disease which as per the investigator might interfere with patient’s participation in the study or would jeopardize the outcome of the trial
  • Patients with any contraindications for Imeglimin, including hypersensitivity to the active substances or any of the excipients
  • Patients with Moderate or severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)less than 45 mL/min/1.73 m2)
  • Patients with severe hepatic dysfunction
  • Patients undergoing insulin treatment
  • Patients currently participating in another clinical/investigational study
  • Patients who participated in another interventional T2DM clinical study within 3 months prior enrolment into the current study
  • Patients who, in the opinion of the investigator, are unlikely to comply with the study protocol or follow-up requirements.

结局指标

主要结局

Glycemic Profile Assessment, based on pre- & post administration changes in the following parameters: [Time Frame: From Enrolment to EOS (Week 12)]

时间窗: 14 to 16 weeks

- Mean amplitude of glycemic excursions (MAGE)

时间窗: 14 to 16 weeks

- Time in Range (TIR)

时间窗: 14 to 16 weeks

- Time above Range (TAR)

时间窗: 14 to 16 weeks

- Time below Range (TBR)

时间窗: 14 to 16 weeks

- Glycemic Variability (GV) using the coefficient of variation of blood glucose

时间窗: 14 to 16 weeks

次要结局

  • Efficacy will be determined based on the following parameters:(-Change in Homeostasis Model Assessment of Beta-cell Function (Homa-β) & Homeostasis Model Assessment of Insulin Resistance (Homa-IR))

研究者

发起方
Dr Unnikrishnan Ambika Gopalakrishnan
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Unnikrishnan Ambika Gopalakrishnan

Chellaram Diabetes Institute

研究点 (1)

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