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

A Multi-center, phase3, Open-label Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Gemigliptin

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.

Study Overview

• Status: Not yet recruiting
• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Drug: DWP16001 0.3 mg

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 Type: Interventional
• Enrollment (Estimated): 134
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jayoung Shon; Phone Number: +82-10-9811-6679; Email: jyshon@daewoong.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group (DWP16001 0.3 mg); DWP16001 0.3mg, Tablets, Orally, Once daily	Drug: DWP16001 0.3 mg; DWP16001 0.3mg, Tablets, Orally, Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Soo Lim, MD, PH.D, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DW_DWP16001308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No