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

NCT ID: NCT06141980

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-09-30

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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group (DWP16001 0.3 mg)

DWP16001 0.3mg, Tablets, Orally, Once daily

Group Type: EXPERIMENTAL

DWP16001 0.3 mg

Intervention Type: DRUG

DWP16001 0.3mg, Tablets, Orally, Once daily

Interventions

DWP16001 0.3 mg

DWP16001 0.3mg, Tablets, Orally, Once daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soo Lim, MD, PH.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Central Contacts

Jayoung Shon

Role: CONTACT

jyshon@daewoong.co.kr

+82-10-9811-6679

Other Identifiers

DW_DWP16001308

Identifier Type: -

Identifier Source: org_study_id