A Study to Evaluate the Efficacy and Safety of Dual add-on Therapy With Gemigliptin 50 mg and Dapagliflozin 10 mg Added to Metformin Who Have Inadequate Glycemic Control on Metformin Alone

Sponsor
LG Chem
Study ID
NCT04255238
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Gemigliptin 50mg — DRUG
    The subjects should visit a study site 6-7 times during the treatment period for about 24 weeks in total. - Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day
  • Dapagliflozin 10mg — DRUG
    The subjects should visit a study site 6-7 times during the treatment period for about 24 weeks in total. - Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day

Study Details

The objective of this study is to evaluate the efficacy and safety of dual add-on therapy with Gemigliptin 50 mg and Dapagliflozin 10 mg added to Metformin compared to add-on therapy with Gemigliptin 50 mg in combination with Metformin or Dapagliflozin 10 mg in combination with Metformin in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone

Key Dates

Start date
Jun 30, 2020
Status verified
Feb 2020
Primary completion
May 30, 2022
Completion
Dec 30, 2022

Study Design

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

Arms

  • Experimental: Gemigliptin 50 mg and Dapagliflozin 10 mg
    * Subject shoud took 1 tablet of Gemigliptin 50 mg and 1 tablet of Dapagliflozin 10 mg per day * Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day
  • Active Comparator: Gemigliptin 50 mg and Dapagliflozin placebo
    * Subject shoud took 1 tablet of Gemigliptin 50 mg and 1 tablet of Dapagliflozin placebo per day * Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day
  • Active Comparator: Gemigliptin placebo and Dapagliflozin 10mg
    * Subject shoud took 1 tablet of Gemigliptin placebo and 1 tablet of Dapagliflozin 10 mg per day * Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day

Primary Outcome Measure

Chages from baseline HbA1c at Week24 [ Time Frame: Baseline to Week24 ]

Central Contacts

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