Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin

Sponsor
Celltrion
Study ID
NCT07093476
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • DM
  • Diabete Type 2
  • T2DM

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    tablets, QD, oral administration
  • Alogliptin — DRUG
    tablets, QD, oral administration
  • empagliflozin — DRUG
    tablets, QD, oral administration

Study Details

Phase 3 study to assess the Efficacy and Safety of CT-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin Combination Therapy.

Key Dates

Start date
Jul 18, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
171 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Study group 1
    Metformin + Alogliptin + Empagliflozin Xmg
  • Active Comparator: Study group 2
    Metformin + Alogliptin + Empagliflozin Ymg
  • Placebo Comparator: Control Group
    Metformin + Alogliptin

Primary Outcome Measure

HbA1c [ Time Frame: Week 24 of the Treatment ]

Central Contacts

Related Studies