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

NCT07057479 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione

Oral fixed-dose combination tablet containing an SGLT2 inhibitor and a thiazolidinedione, administered once daily. Participants also receive matching placebos for both comparator drugs to maintain blinding. All participants continue background metformin therapy (≥1000mg/day).

DRUG

Control Group 1 Intervention - SGLT2 inhibitor monotherapy

Oral tablet containing an SGLT2 inhibitor, administered once daily. Participants also receive matching placebos for both the fixed-dose combination and the thiazolidinedione comparator to maintain blinding. All participants continue background metformin therapy (≥1000mg/day). This represents standard monotherapy for comparison against the combination approach.

DRUG

Control Group 2 Intervention - Thiazolidinedione monotherapy

Oral tablet containing a thiazolidinedione, administered once daily. Participants also receive matching placebos for both the fixed-dose combination and the SGLT2 inhibitor comparator to maintain blinding. All participants continue background metformin therapy (≥1000mg/day). This represents standard monotherapy for comparison against the combination approach.

DRUG

Background Therapy (All Groups) - Metformin

Extended-release metformin tablets (≥1000mg daily) continued as background therapy for all participants throughout the study duration.

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07057479 on ClinicalTrials.gov