A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy

Sponsor
Celltrion Pharm, Inc.
Study ID
NCT03499704
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pioglitazone + Alogliptin — DRUG
    Pioglitazone and Alogliptin FDC tablets
  • Alogliptin — DRUG
    Alogliptin tablets.
  • Metformin — DRUG
    Metformin tablets.
  • Dapagliflozin — DRUG
    Dapagliflozin tablets.

Study Details

The purpose of this study is to assess the pioglitazone plus alogliptin plus metformin is non-inferior to dapagliflozin plus alogliptin plus metformin on glycosylated haemoglobin (HbA1c) change from baseline at Week 26.

Key Dates

Start date
Feb 11, 2020
Status verified
Feb 2025
Primary completion
Jan 2, 2024
Completion
Jan 16, 2024

Study Design

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

Arms

  • Experimental: Pioglitazone + Alogliptin + Metformin (PAM)
    Pioglitazone 15 milligram (mg) and alogliptin 25 mg in fixed dose combination (FDC) tablet (SYR-322-4833), orally once daily and metformin greater than or equal to (\>=) 500 mg, tablet, orally, twice a day for up to 26 weeks. At Week 12, if participants has HbA1c \>=7.5%, pioglitazone dose will be titrated up to 30 mg based on investigator's opinion and up-titrated dose will be maintained up to Week 26.
  • Active Comparator: Dapagliflozin + Alogliptin + Metformin (DAM)
    Dapagliflozin 10 mg, tablet, orally, once daily with alogliptin 25 mg, tablet, orally, once daily, and metformin \>=500 mg, tablet, orally, twice a day, for up to Week 26.

Primary Outcome Measure

Mean Change from Baseline in HbA1c at Week 26 [ Time Frame: Baseline and Week 26 ]

Related Studies