Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus

Launched by DAEWOONG PHARMACEUTICAL CO. LTD. · Nov 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called DWP16001 to see how safe and effective it is for people with Type 2 Diabetes Mellitus (T2DM) over a one-year period. The trial is looking for adults aged 19 to under 80 who have been managing their diabetes with specific medications, including metformin and gemigliptin, for at least 8 weeks. To qualify, potential participants need to have certain blood sugar levels and meet other health criteria, ensuring they are suitable for the study.

If you decide to participate, you will take DWP16001 once a day for 52 weeks and visit the trial site several times during the year to check on your safety and how well the medication is working. The trial is currently not recruiting participants, but it aims to gather important information about this new treatment for individuals with Type 2 Diabetes. Your involvement will help researchers understand how this medication can improve diabetes management for patients like you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects with T2DM age 19 \~ under 80 years
• • 2. Subjects who have 7% ≤ HbA1c ≤ 11% in screening visit(V1-1)
• • 3. Subjects who have FPG \<270 mg/dl screening visit(V1-1)
• • 4. Subjects who have received a combination of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day) for a minimum of 8 weeks prior to Visit 2 (Enrollment Visit)
• • 5. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study
• Exclusion Criteria:
• • 1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
• • 2. Diabetic ketoacidosis, diabetic coma or precoma within the past year
• • 3. Urinary tract infections or genital infections within
• • 4. Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg)
• • 5. eGFR \< 45 mL/min/1.73 m2
• • 6. Severe heart failure (NYHA class III/IV