None listed
Conditions
Interventions
Intervention1: Imeglimin: Imeglimin in patients with T2DM. Using CGM technology.
Dose-1000mg twice a day for 12 weeks
Control Intervention1: Nil: Nil
Sponsors
Dr Unnikrishnan Ambika Gopalakrishnan
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years 2. Patients diagnosed with T2DM for more than 180 days 3. 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) 4. Patients / Legally Acceptable Representative who are willing to provide written informed consent. 5. Patients who are willing and able to comply with study procedures and follow-up assessments
Exclusion criteria
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. 2. Female patients who are pregnant, breastfeeding, or planning to become pregnant during the conduct of the study 3. 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 4. Patients with any contraindications for Imeglimin, including hypersensitivity to the active substances or any of the excipients 5. Patients with Moderate or severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR)less than 45 mL/min/1.73 m2) 6. Patients with severe hepatic dysfunction 7. Patients undergoing insulin treatment 8. Patients currently participating in another clinical/investigational study 9. Patients who participated in another interventional T2DM clinical study within 3 months prior enrolment into the current study 10. Patients who, in the opinion of the investigator, are unlikely to comply with the study protocol or follow-up requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic Profile Assessment, based on pre- & post administration changes in the following parameters: [Time Frame: From Enrolment to EOS (Week 12)] - Mean amplitude of glycemic excursions (MAGE) - Time in Range (TIR) - Time above Range (TAR) - Time below Range (TBR) - Glycemic Variability (GV) using the coefficient of variation of blood glucoseTimepoint: 14 to 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy will be determined based on the following parameters: -Change in Homeostasis Model Assessment of Beta-cell Function (Homa-ß) & Homeostasis Model Assessment of Insulin Resistance (Homa-IR) [Time Frame: Enrolment and EOS (Week 12)] - Mean change in Hemoglobin A1c (HbA1c) [Time Frame:Enrolment and EOS (Week 12)] - Mean change in Fasting Blood Glucose (FBG) levels [Time Frame: Enrolment and EOS (Week 12)] - Mean change in Post Prandial Blood Glucose (PPG) levels [Time Frame: Enrolment and EOS (Week 12)] - Mean change in Fasting & Post Prandial C- Peptide levels [Time Frame: Enrolment and EOS (Week 12)] • Safety will be assessed based on number of Adverse Eventsn(AEs) and Serious Adverse Events (SAEs) reported [Time Frame: From Enrolment to EOS (12 weeks) Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Unnikrishnan Ambika Gopalakrishnan
Chellaram Diabetes Institute
Outcome results
None listed