In Dual Therapy With Sitagliptin,The Efficacy Of Imeglimin Vs. Metformin On Control Of Blood Glucose And Weight Management: A Controlled Randomized Trial
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2024/03/063895
- Lead Sponsor
- SRM College of Pharmacy, SRM Institute of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
Individuals presenting with T2DM fulfilling the following criteria: QUIKI Index <0.36, KIER Scoring System >60, Fasting Blood glucose 110- 250 mg/dl, HbA1c 6.5-9.0 % , Score of 3-4 on the DSMQ Scale
Glycated Hemoglobin Above 10.0%
Planned To Start Treatment with Insulin During the Intervention Period.
Patients with severe Heart (Congenital Heart Failure, Valve diseases, Unstable Angina), Liver (Decompensated Liver Disease, Alcoholic Liver Disease, Non-Alcoholic Fatty Liver Disease), Or Kidney Disease (chronic kidney disease stage II –IV) or Incurable Cancer.
Patients with Type 1 Diabetes Mellitus.
Prior history of ketoacidosis.
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
Women who are on gestation, lactating, nursing and who plan to become pregnant will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method