Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Imeglimin oral: Oral hypoglycemic agent (anti-diabetic drug)
Dosage: 1000mg per day
Intervention period: 6 months
Intervention2: Imeglimin oral add on to metformin oral: Metformin oral
Sponsors
SRM Medical College Hospital and Research Centre, SRMIST
Eligibility
Inclusion criteria
Inclusion criteria: 1. The target population for the trial: Type 2 Diabetes Mellitus Patients (more than 30 years of age). 2. Individuals with Fasting blood glucose levels of more than 125 mg/dL 3. Post-prandial blood glucose level of more than 199 mg/dL. 4. HbA1C levels of more than 6.4%.
Exclusion criteria
Exclusion criteria: 1. Previous intolerance of Metformin and/or Imeglimin. 2. Any contraindication to Metformin and/or Imeglimin, as listed in the current summary of medicinal product characteristics for Metformin and Imeglimin. 3. Any medication which significantly interacts with Metformin and/or Imeglimin, as listed in the current summary of medicinal product characteristics for metformin. 4. Estimated glomerular filtration rate mL/min/1.73 m2 or Chronic Kidney Disease. 5. History of diarrheal illness within the last three months. 6. Symptomatic chronic heart failure. 7. Liver function tests (bilirubin, alanine aminotransferase or alkaline phosphatase) >3× upper limit of normal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improved Mitochondrial function and lower levels of telomere attrition in the treatment groupTimepoint: 0 to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| PGC-1 alpha differential expression before and after interventionTimepoint: 0 to 6 months | — |
Countries
India
Contacts
Public ContactDr J S Kumar
SRM Medical College Hospital and Research Centre SRMIST
Outcome results
None listed