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

NCT04654390 | Completed Phase 3

• 1 other identifier: DW_DWP16001303
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes from Visit 2 (randomization) in 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

  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

  at weeks 6, 12, 18, and 24

Study Arms (2)

DWP16001 Amg, Dapagiflozin Bmg placebo

EXPERIMENTAL

Tablets, Orally, Once daily

Drug: DWP16001 Amg

DWP16001 Amg placebo, Dapagliflozin Bmg

ACTIVE COMPARATOR

Tablets, Orally, Once daily

Drug: DWP16001 Amg

Interventions

DWP16001 Amg DRUG

Tablets, Orally, Once daily

DWP16001 Amg placebo, Dapagliflozin Bmg; DWP16001 Amg, Dapagiflozin Bmg placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
• Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
• Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
• eGFR \< 60 mL/min/1.73 m2
• 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.
• Uncontrolled hypertension (SBP \>180 mmHg or DBP \> 110 mmHg)

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

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

Bucheon-si, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Sungrae KIm, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 4, 2020
• Study Start: December 30, 2020
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)