iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD) (TRIAD)

December 11, 2025 updated by: Eurofarma Laboratorios S.A.

Evaluate the Efficacy and Safety of the Combined Use of a Sodium-glucose Cotransporter 2 (iSGLT2) Inhibitor and a Dipeptidyl Peptidase-4 (iDPP -4) Inhibitor in the Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin

The present study aims to evaluate the efficacy and safety of different combinations of oral antidiabetics in patients with inadequate glycemic control on metformin monotherapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a phase III, multicenter, randomized, double-blind, double-dummy clinical trial to evaluate the efficacy and safety of the he fixed-dose combination in patients diagnosed with type 2 DM (Diabetes mellitus), with or without cardiovascular or renal complications, and who did not reach the therapeutic goals of glycemic control with previous guidance on diet and physical exercise, on monotherapy with metformin at the maximum tolerated dose, and who, at the discretion of the Investigator, may benefit from the addition of trial drugs.

The trial will have a total duration of a maximum of 144 days (approximately 20 weeks), with a screening/run-in period of up to 4 weeks and 16 weeks (112 ± 4 days) of treatment. The trial will include a screening visit (V-1), a baseline randomisation visit (V0), three follow-up visits (V1, V2, V3) and a final visit (V4).

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 06696-00
        • Eurofarma Laboratórios S.A

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability to confirm voluntary participation and agree with all the purposes of the trial, signing and dating the ICF in two copies;
  • Age equal to or over 18 years old and less than or equal to 80 years old
  • Diagnosis of type 2 DM with uncontrolled glycemia with a history of HbA1c ≥7.5% and ≤10.5% (up to 12 previous months) with previous guidance on diet and physical exercise and monotherapy with metformin at the maximum tolerated dose (≥1,000 mg/day, stable and without signs of intolerance in the last 12 weeks) and who, at the Investigator's discretion, may benefit from the addition of the trial drugs

Exclusion Criteria:

  • Any clinical observation finding (clinical/physical assessment) or laboratory condition that is interpreted by the investigating physician as a risk to the research Subject's participation in the clinical trial or the presence of uncontrolled chronic disease(s);
  • History of alcohol or illicit drug use disorder in the two years prior to the Visit;
  • Subjects who are pregnant, breastfeeding or planning to become pregnant, or female subjects of childbearing potential who are not using a reliable method of contraception;
  • Known history of allergy or hypersensitivity to any of the trial treatments, or to the excipients in the formulas, or in case of rare hereditary diseases which may be incompatible with the excipients in the product formulas (such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption);
  • Subjects with type 1 diabetes mellitus;
  • History of fasting blood glucose ≥ 270 mg/dL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N0892
in the test group will be required to take 3 tablet of the test drug N0892. 3 tablets a day for 84 days +/- 4 days.
Drug: N0892
1 tablet of Forxiga® 10mg, 1 tablet of Januvia® 100mg and 1 tablet of Glifage XR® 1000mg
Active Comparator: Forxiga® + Glifage XR® + Placebo of Januvia®
in the control group will be required to take 1 tablet of Forxiga® 10mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Januvia® 100mg. 3 tablets a day for 84 days +/- 4 days.
Drug: Forxiga® + Glifage XR® + Placebo
1 tablet of Forxiga ®10mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Januvia ® 100mg
Active Comparator: Januvia® + Glifage XR® + Placebo of Forxiga®
in the control group will be required to take 1 tablet of Januvia® 100mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Forxiga® 100mg. 3 tablets a day for 84 days +/- 4 days.
Drug: Januvia® + Glifage XR® + Placebo
1 tablet of Januvia® 100mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Forxiga ®10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the glycemic control at week 16
Time Frame: 16 weeks
Evaluate the superiority of the combined use of N0892 in glycemic control (reduction in HbA1c: Glycated haemoglobin) at week 16 in subjects receiving metformin, compared to Forxiga® and Januvia® alone
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF186

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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