Comparison of Dapagliflozin, Lobeglitazone, and Its Combination in Efficacy and Safety

Sponsor
Seoul National University Bundang Hospital
Study ID
NCT05915949
Phase
PHASE4
Status
Unknown

Conditions

  • Diabetes Type 2

Eligibility Criteria

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

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Forxiga 10mg Tab once daily will be given to participants for 24 weeks.
  • Lobeglitazone 0.5 mg — DRUG
    Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.
  • Dapagliflozin + Lobeglitazone — DRUG
    Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.

Study Details

Diabetes is the most frequently occurring chronic disease along with obesity, hypertension, and hyperlipidemia. The number of patients with diabetes is increasing worldwide. Despite rapid progress in management of diabetes, the problem is that glycemic target goal is still low showing 30-40%. Thus, diabetes has become a serious social, economic, and public health problem beyond individual health problems due to its increasing prevalence.

Key Dates

Start date
Jan 1, 2022
Status verified
Aug 2023
Primary completion
Oct 30, 2023
Completion
Dec 31, 2023

Study Design

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

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10 mg once daily will be given to participants.
  • Active Comparator: Lobeglitazone
    Lobeglitazone 0.5 mg once daily will be given to participants.
  • Active Comparator: Dapagliflozin and Lobeglitazone combined
    Dapagliflozin 10 mg and lobeglitazone 0.5 mg once daily together will be given to participants.

Primary Outcome Measure

HbA1c [ Time Frame: 6 months ]

Central Contacts

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