Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2724
Source ID: NCT06141980
Associated Drug: Dwp16001 0.3 Mg
Title: Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: T2DM (Type 2 Diabetes Mellitus)
Interventions: DRUG: DWP16001 0.3 mg
Outcome Measures: Primary: Safety outcomes_Adverse events occurred during clinical trials, Safety outcomes_Adverse events occurred during clinical trials, from baseline up to 52 weeks|Safety outcomes_ Change of blood pressure, Safety outcomes_ Change of blood pressure, from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP|Safety outcomes_ Change of heartbeat, Safety outcomes_ Change of heartbeat, from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP|Safety outcomes_ Change of body temperature, Safety outcomes_ Change of body temperature, from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP|Efficacy outcome_Change of HbA1c, Efficacy outcome_Change of HbA1c, from Baseline at Week 8, 16, 24, 38, and 52 after administration of the IP|Efficacy outcome_Change of FPG, Efficacy outcome_Change of FPG, from baseline at Week 8, 16, 24, 38, and 52 after administration of the IP|Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5%, Efficacy outcome_Proportion of subjects achieving HbA1c target of \< 6.5%, at Weeks 8, 16, 24, 38 and 52 after administration of the IP|Efficacy outcome_Proportion of subjects achieving HbA1c target of < 7.0 %, Efficacy outcome_Proportion of subjects achieving HbA1c target of \< 6.5%, at Weeks 8, 16, 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: 134
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-12
Completion Date: 2025-09
Results First Posted:
Last Update Posted: 2023-11-21
Locations:
URL: https://clinicaltrials.gov/show/NCT06141980