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

Phase 3

Not yet recruiting

• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Interventions: Drug: DWP16001 0.3 mg

• Registration Number: NCT06141980
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period.

At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.

The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Detailed Description

The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. Throughout this period, subjects will receive concurrent administration of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day), and will have a washout period for other oral antidiabetic drugs.

At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.

The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study First Posted: 2023-11-21
• Last Update Posted: 2023-11-21
• Study Start: 2023-12
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group (DWP16001 0.3 mg)	DWP16001 0.3 mg	DWP16001 0.3mg, Tablets, Orally, Once daily

Primary Outcome Measures

Name	Time	Method
Safety outcomes_Adverse events occurred during clinical trials	from baseline up to 52 weeks	Safety outcomes_Adverse events occurred during clinical trials
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 blood pressure
Safety outcomes_ Change of heartbeat	from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP	Safety outcomes_ Change of heartbeat
Safety outcomes_ Change of body temperature	from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP	Safety outcomes_ Change of body temperature
Efficacy outcome_Change of HbA1c	from Baseline at Week 8, 16, 24, 38, and 52 after administration of the IP	Efficacy outcome_Change of HbA1c
Efficacy outcome_Change of FPG	from baseline at Week 8, 16, 24, 38, and 52 after administration of the IP	Efficacy outcome_Change of FPG
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 \< 6.5%
Efficacy outcome_Proportion of subjects achieving HbA1c target of < 7.0 %	at Weeks 8, 16, 24, 38 and 52 after administration of the IP	Efficacy outcome_Proportion of subjects achieving HbA1c target of \< 6.5%