Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Tab. Imeglimin added as a 3rd drug in patients with Uncontrolled Type 2 Diabetes Mellitus for 12 weeks: Tablet Imeglimin 500mg BD as a 3rd drug in patients with Uncontrolled Type 2 Diab
Sponsors
Government Kilpauk Medical College
Eligibility
Inclusion criteria
Inclusion criteria: Patients between 40 to 60 years Patients with uncontrolled Type2 Diabetes Mellitus with HbA1C-8-11% and under combination therapy with Biguanides and Sulfonylureas Patients with Type 2 DM of more than 5 years
Exclusion criteria
Exclusion criteria: Patients less than 18 years and more than 60 years. Pregnant and lactating women Patients under insulin therapy Patients with impaired hepatic and renal function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Tab. Imeglimin in lowering the HbA1C levels and fasting glucose levels and in achieving adequate control (HbA1c less than 7%) from the baseline in comparison with Tab. Sitagliptin as a 3rd drug in patients with uncontrolled Type 2 Diabetes MellitusTimepoint: Fasting Blood Sugar at baseline 4,8 and 12 weeks HbA1C at baseline and and at the end of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To analyze the safety and tolerability of Imeglimin with that of SitagliptinTimepoint: CBC,LFT,RFT,LIPID PROFILE, SERUM ELECTROLYTES at baseline and at the end of 12 weeks | — |
Countries
India
Contacts
Public ContactDr Bagiyalakshmi V
Government Kilpauk Medical College
Outcome results
None listed