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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04654390

Enrollment

270

Registered

2020-12-04

Start date

2020-12-30

Completion date

2021-12-17

Last updated

2022-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T2DM (Type 2 Diabetes Mellitus)

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.

Interventions

DRUGDWP16001 Amg

Tablets, Orally, Once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	HbA1c level at Weeks 6, 12, and 18 after administration of the IP
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	FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
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	HbA1c level \< 7% at Weeks 6, 12, 18, and 24 after administration of the IP

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026