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
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Glycemic Profile Assessment, based on pre- & post administration changes in the following parameters: [Time Frame: From Enrolment to EOS (Week 12)]
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Glycemic Profile Assessment, based on pre- & post administration changes in the following parameters: [Time Frame: From Enrolment to EOS (Week 12)]
Time Frame: 14 to 16 weeks
- Mean amplitude of glycemic excursions (MAGE)
Time Frame: 14 to 16 weeks
- Time in Range (TIR)
Time Frame: 14 to 16 weeks
- Time above Range (TAR)
Time Frame: 14 to 16 weeks
- Time below Range (TBR)
Time Frame: 14 to 16 weeks
- Glycemic Variability (GV) using the coefficient of variation of blood glucose
Time Frame: 14 to 16 weeks
Secondary Outcomes
- 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))
Investigators
Dr Unnikrishnan Ambika Gopalakrishnan
Chellaram Diabetes Institute