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

NCT ID: NCT06560333

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-11-30
• Study Completion Date: 2029-02-28

Brief Summary

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.

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).

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

N0892

Intervention Type: DRUG

1 tablet of Forxiga® 10mg, 1 tablet of Januvia® 100mg and 1 tablet of Glifage XR® 1000mg

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.

Group Type: ACTIVE_COMPARATOR

Forxiga® + Glifage XR® + Placebo

Intervention Type: DRUG

1 tablet of Forxiga ®10mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Januvia ® 100mg

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.

Group Type: ACTIVE_COMPARATOR

Januvia® + Glifage XR® + Placebo

Intervention Type: DRUG

1 tablet of Januvia® 100mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Forxiga ®10mg

Interventions

Forxiga® + Glifage XR® + Placebo

1 tablet of Forxiga ®10mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Januvia ® 100mg

Intervention Type: DRUG

N0892

1 tablet of Forxiga® 10mg, 1 tablet of Januvia® 100mg and 1 tablet of Glifage XR® 1000mg

Intervention Type: DRUG

Januvia® + Glifage XR® + Placebo

1 tablet of Januvia® 100mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Forxiga ®10mg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofarma Laboratorios S.A

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF186

Identifier Type: -

Identifier Source: org_study_id