Comparison of Effectiveness and Safety of Imeglimin and Metformin monotherapy in type 2 Diabetes: A Study
Phase 4
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/08/056584
- Lead Sponsor
- Other Self
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Newly Diagnosed cases with Type 2 Diabetes Mellitus
HbA1c >7.5% and <9%
Exclusion Criteria
Female patient who are pregnant and lactating
Patients on any other glucose lowering agent
Establised Cardiovascular disease, Compromised renal Function(eGFR <60) AND Liver function (enzymes >3 ULN) and psychiatric illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of HBA1c at week 16th with respect to week 0Timepoint: Change of HBA1c at week 16th with respect to week 0
- Secondary Outcome Measures
Name Time Method Change in FPG & PPPG <br/ ><br>Adverse reaction <br/ ><br>Adherence to medicationTimepoint: Week 8,12,16