Efficacy and Safety of LID104 in the Treatment of Type II Diabetes Mellitus

Sponsor
EMS
Study ID
NCT05886088
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • LID104 — DRUG
    Experimental
  • Dapagliflozin — DRUG
    Active comparator
  • Linagliptin — DRUG
    Active comparator

Study Details

The purpose of this study is to evaluate the efficacy and safety of LID104 in the treatment of type 2 diabetes mellitus.

Key Dates

Start date
Feb 29, 2024
Status verified
May 2023
Primary completion
May 31, 2026
Completion
Jan 31, 2027

Study Design

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

Arms

  • Experimental: LID104
    The patient must take 1 tablet of LID104 plus 1 tablet of placebo of dapagliflozin and 1 tablet of placebo of linagliptin once a day.
  • Active Comparator: Dapagliflozin
    The patient must take 1 tablet of dapagliflozin plus 1 tablet of placebo of LID104 and 1 tablet of placebo of linagliptin once a day.
  • Active Comparator: Linagliptin
    The patient must take 1 tablet of linagliptin plus 1 tablet of placebo of LID104 and 1 tablet of placebo of dapagliflozin once a day.

Primary Outcome Measure

Glycated hemoglobin (HbA1c) [ Time Frame: 120 days ]

Central Contacts

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