Diabetes Mellitus, Type 2Phase 3TRIADNCT06560333
iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD)
A Phase 3 study testing N0892 in people with Diabetes Mellitus, Type 2, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- N0892
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Nov 2026to 28 Feb 2029
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- N0892, Januvia® + Glifage XR® + Placebo, Forxiga® + Glifage XR® + Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N0892Drug
1 tablet of Forxiga® 10mg, 1 tablet of Januvia® 100mg and 1 tablet of Glifage XR® 1000mg
Januvia® + Glifage XR® + PlaceboDrug
1 tablet of Januvia® 100mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Forxiga ®10mg
Forxiga® + Glifage XR® + PlaceboDrug
1 tablet of Forxiga ®10mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Januvia ® 100mg
| Study group | Role | What they receive |
|---|---|---|
| N0892 | Experimental | 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. Receives: Drug: N0892 |
| Forxiga® + Glifage XR® + Placebo of Januvia® | Active comparator | 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. Receives: Drug: Forxiga® + Glifage XR® + Placebo |
| Januvia® + Glifage XR® + Placebo of Forxiga® | Active comparator | 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. Receives: Drug: Januvia® + Glifage XR® + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the glycemic control at week 16
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start30 Nov 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion28 Feb 2029 (estimated)
Why it stopped: Strategic change in development priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560333
- Sponsor's protocol ID
- EF186
- Acronym
- TRIAD
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06560333
- Acronym / sponsor ID
- TRIAD / EF186
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic change in development priorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| N0892 | Experimental | Drug: N0892in the test group will be required to take 3 tablet of the test drug N0892. 3 tablets a day for 84 days +/- 4 days. |
| Forxiga® + Glifage XR® + Placebo of Januvia® | Active comparator | Drug: Forxiga® + Glifage XR® + Placeboin 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. |
| Januvia® + Glifage XR® + Placebo of Forxiga® | Active comparator | Drug: Januvia® + Glifage XR® + Placeboin 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N08921 tablet of Forxiga® 10mg, 1 tablet of Januvia® 100mg and 1 tablet of Glifage XR® 1000mg | Drug | N0892 |
| Januvia® + Glifage XR® + Placebo1 tablet of Januvia® 100mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Forxiga ®10mg | Drug | Januvia® + Glifage XR® + Placebo of Forxiga® |
| Forxiga® + Glifage XR® + Placebo1 tablet of Forxiga ®10mg, 1 tablet of Glifage XR® 1000mg and 1 tablet of Placebo of Januvia ® 100mg | Drug | Forxiga® + Glifage XR® + Placebo of Januvia® |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N0892 in people with Diabetes Mellitus, Type 2, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the glycemic control at week 16 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.