The Efficacy Nad Safety of DWP16001 Compared to Active Drug in the Treatment of Type 2 Diabetes Mellitus

A Multi-center, Randomized, Double-Blind, Active-controlled, Phase3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine the efficacy and safety of DWP16001 compared to active drug in the treatment of type 2 diabetes mellitus.

Study Overview

• Status: Completed
• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Drug: DWP16001 Amg

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults aged 19 to 80 years
2. Subjects with 7% ≤ HbA1c ≤ 11% at Screening
3. Subjects with BMI of 20-45 kg/m2

Exclusion Criteria:

1. Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
2. Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
3. Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
4. eGFR < 60 mL/min/1.73 m2
5. Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.
6. Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DWP16001 Amg, Dapagiflozin Bmg placebo; Tablets, Orally, Once daily	Drug: DWP16001 Amg; Tablets, Orally, Once daily
ACTIVE_COMPARATOR: DWP16001 Amg placebo, Dapagliflozin Bmg; Tablets, Orally, Once daily	Drug: DWP16001 Amg; Tablets, Orally, Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Visit 2(Randomization) in HbA1c level at Week 24 after administation of the IP	HbA1c level at Week 24 after administration of the IP	at Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 after administration of the IP	HbA1c level at Weeks 6, 12, and 18 after administration of the IP	at weeks 6, 12, and 18
Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP	FPG level at Weeks 6, 12, 18, and 24 after administration of the IP	at weeks 6, 12, 18, and 24
Proportions of subjects who achieved HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP	HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP	at weeks 6, 12, 18, and 24

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Study Director: Sungrae KIm, MD, PhD, The Catholic University of Korea Bucheon St. Mary's Hospital, Republic of Korea

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2020
• Primary Completion (ACTUAL): December 17, 2021
• Study Completion (ACTUAL): December 17, 2021

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (ACTUAL): December 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

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_DWP16001303

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