A clinical trial to study the effect of Imeglimin on cellular energy production and ageing in Type 2 Diabetes Mellitus Patients
- Conditions
- Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
- Registration Number
- CTRI/2023/12/060844
- Lead Sponsor
- SRM Medical College Hospital and Research Centre, SRMIST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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%.
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 <45
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method