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

NCT06141980 | Unknown Phase 3

• 1 other identifier: DW_DWP16001308
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Study group (DWP16001 0.3 mg)

EXPERIMENTAL

DWP16001 0.3mg, Tablets, Orally, Once daily

Drug: DWP16001 0.3 mg

Interventions

DWP16001 0.3 mg DRUG

DWP16001 0.3mg, Tablets, Orally, Once daily

Study group (DWP16001 0.3 mg)

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with T2DM age 19 \~ under 80 years
• Subjects who have 7% ≤ HbA1c ≤ 11% in screening visit(V1-1)
• Subjects who have FPG \<270 mg/dl screening visit(V1-1)
• 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)
• Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

You may not qualify if:

• 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)
• Diabetic ketoacidosis, diabetic coma or precoma within the past year
• Urinary tract infections or genital infections within
• Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg)
• eGFR \< 45 mL/min/1.73 m2
• Severe heart failure (NYHA class III/IV

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Enavogliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Soo Lim, MD, PH.D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayoung Shon

CONTACT

+82-10-9811-6679; jyshon@daewoong.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 21, 2023
• Study Start: December 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share