Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560333
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin TRIAD
Sponsor:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 screeningrun-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 screeningrun-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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None