Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin

Sponsor
Celltrion
Study ID
NCT06571591
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • CT-L03 Group 1 — DRUG
    tablets, QD, oral administration
  • CT-L03 Group 2 — DRUG
    tablets, QD, oral administration
  • Placebo — DRUG
    tablets, QD, oral administration
  • Empagliflozin — DRUG
    tablet, QD, oral administration
  • Metformin — DRUG
    tablets, oral administration

Study Details

Phase 3 study to assess the Efficacy and Safety of CT-L03-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Empagliflozin Combination Therapy.

Key Dates

Start date
Aug 27, 2024
Status verified
May 2026
Primary completion
Apr 16, 2026
Completion
May 4, 2026

Study Design

Enrollment
606 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1
  • Active Comparator: Group 2
  • Placebo Comparator: Placebo

Primary Outcome Measure

HbA1c [ Time Frame: Week 24 of the Treatment ]

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