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In Dual Therapy With Sitagliptin,The Efficacy Of Imeglimin Vs. Metformin On Control Of Blood Glucose And Weight Management: A Controlled Randomized Trial

The Efficacy Of Imeglimin Compared To Metformin In Dual Therapy With Dpp-4 Inhibitor On Glycemic Control And Weight Management: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063895
Enrollment
111
Registered
2024-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Glycemic Control and Weight Management: HbA1c, FBS, KIER index, QUICKI index, BMI, Body composition metrics, Waist to hip ratio, Waist to height ratio, DMSQ score and ADEs Interve

Sponsors

SRM College of Pharmacy, SRM Institute of Science and Technology
Lead Sponsor
Aparna
Collaborator
Dev Sudersan
Collaborator
Dhivakar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Individuals presenting with T2DM fulfilling the following criteria: QUIKI Index 60, Fasting Blood glucose 110- 250 mg/dl, HbA1c 6.5-9.0 % , Score of 3-4 on the DSMQ Scale

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
QUIKI Index KIER Scoring System Fasting Blood glucose HbA1c Score of DSMQ Scale Score of MARS-10 ScaleTimepoint: In the initial, patient’s HbA1c, FBS value will be evaluated, KIER index and QUICKI index will also be calculated, DSMQ score will also be assessed before recruiting the patient for the study. Mean changes in the parameters observed at 6th week, 12th week, 18th week and 24th week.—

Secondary

MeasureTime frame
ADETimepoint: In the initial, patient’s HbA1c, FBS value will be evaluated, KIER index and QUICKI index will also be calculated, DSMQ score will also be assessed before recruiting the patient for the study. Mean changes in the parameters observed at 6th week, 12th week, 18th week and 24th week.—

Countries

India

Contacts

Public ContactA Priyadharshini

SRM College of Pharmacy, SRM Institute of Science and Technology

priyadha@srmist.edu.in9443591925

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026