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

Phase 3

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT06560333
• Lead Sponsor: Eurofarma Laboratorios S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Ability to confirm voluntary participation and agree with all the purposes of the<br> trial, signing and dating the ICF in two copies;<br><br> - Age equal to or over 18 years old and less than or equal to 80 years old<br><br> - Diagnosis of type 2 DM with uncontrolled glycemia with a history of HbA1c =7.5% and<br> =10.5% (up to 12 previous months) with previous guidance on diet and physical<br> exercise and monotherapy with metformin at the maximum tolerated dose (=1,000<br> mg/day, stable and without signs of intolerance in the last 12 weeks) and who, at<br> the Investigator's discretion, may benefit from the addition of the trial drugs<br><br>Exclusion Criteria:<br><br> - Any clinical observation finding (clinical/physical assessment) or laboratory<br> condition that is interpreted by the investigating physician as a risk to the<br> research Subject's participation in the clinical trial or the presence of<br> uncontrolled chronic disease(s);<br><br> - History of alcohol or illicit drug use disorder in the two years prior to the Visit;<br><br> - Subjects who are pregnant, breastfeeding or planning to become pregnant, or female<br> subjects of childbearing potential who are not using a reliable method of<br> contraception;<br><br> - Known history of allergy or hypersensitivity to any of the trial treatments, or to<br> the excipients in the formulas, or in case of rare hereditary diseases which may be<br> incompatible with the excipients in the product formulas (such as galactose<br> intolerance, Lapp lactase deficiency or glucose-galactose malabsorption);<br><br> - Subjects with type 1 diabetes mellitus;<br><br> - History of fasting blood glucose = 270 mg/dL.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the glycemic control at week 16