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

Eurofarma

Status and phase: Begins enrollment in a year or more; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: N0892; Drug: Forxiga® + Glifage XR® + Placebo; Drug: Januvia® + Glifage XR® + Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06560333

EF186 - TRIAD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 612 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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612 participants in 3 patient groups

N0892

Experimental group

Description:

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.

Treatment:

Drug: N0892

Forxiga® + Glifage XR® + Placebo of Januvia®

Active Comparator group

Description:

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.

Treatment:

Drug: Forxiga® + Glifage XR® + Placebo

Januvia® + Glifage XR® + Placebo of Forxiga®

Active Comparator group

Description:

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.

Treatment:

Drug: Januvia® + Glifage XR® + Placebo