Overview

Phase III Trial of SGLT2 Inhibitor and Thiazolidinedione Fixed-Dose Combination vs. Monotherapy in Type 2 Diabetes Patients on Metformin

Status:
NOT_YET_RECRUITING

Trial end date:
2028-02-01

Target enrollment:

Participant gender:

Summary

This clinical trial is studying whether combining two commonly used diabetes medications into a single pill works better than taking them separately for people with type 2 diabetes who are already on metformin. Both medications work in different ways to lower blood sugar - one helps remove excess sugar through urine while the other helps the body use insulin better. The study has two main goals: To see if the combined pill controls blood sugar more effectively than either medication alone To check if combining them reduces common side effects like weight gain and swelling that can occur with one of the medications Participants will be randomly assigned to one of three groups: The new combination pill One of the standard diabetes medications alone The other standard diabetes medication alone All participants will take their assigned treatment daily and attend regular clinic visits for monitoring. Doctors will track blood sugar control, weight changes, and any side effects throughout the study period. This research could lead to a simpler treatment option that combines the benefits of both medications while potentially minimizing side effects. For people with diabetes who often need multiple medications, a combined pill might make treatment easier to manage while providing better blood sugar control.

Phase:

PHASE3

Details

Lead Sponsor:

Eurofarma Laboratorios S.A.

Treatments:

2,4-thiazolidinedione
Metformin