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Clinical Trial Details

Trial ID: L3745
Source ID: NCT05376969
Associated Drug: Dwp16001
Title: Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin
Acronym: ENHANCE-MEXT
Status: COMPLETED
Study Results: NO
Results:
Conditions: T2DM (Type 2 Diabetes Mellitus)
Interventions: DRUG: DWP16001
Outcome Measures: Primary: Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP, \*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria, at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | Secondary: Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP, \* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001302), at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP|Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP, \* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001302), at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP|Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP, \* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001302), at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Sponsor/Collaborators: Sponsor: Daewoong Pharmaceutical Co. LTD.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 159
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-05-25
Completion Date: 2022-05-16
Results First Posted:
Last Update Posted: 2022-10-25
Locations: Daewoong pharmatceutical, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05376969