Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-04 @ 2:33 AM
Study NCT ID:
NCT06560333
Status:
WITHDRAWN
Last Update Posted:
2025-12-18
First Post:
2024-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD)
Sponsor:
Eurofarma Laboratorios S.A.
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Strategic change in development priorities
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIAD
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: