The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

Official title:

A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632862
• Other study ID #: DW_DWP16001301
• Status: Completed
• Phase: Phase 3
• Start date: November 11, 2020
• Est. completion date: November 25, 2021

Study information

• Verified date: October 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 25, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adults aged 19 to 80 years

2. Subjects with 7% = HbA1c = 10% who have been diagnosed with T2DM at least 8 weeks

3. Subjects with BMI of 20-45 kg/m2

4. Subjects who have been on a stable diet and exercise program for at least 8 weeks

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. 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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• DWP16001
DWP16001 A mg

Locations

Country	Name	City	State
Korea, Republic of	Daewoong pharmatceutical	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c level at Week 24 after administration of the IP	1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP	at Week 24
Secondary	HbA1c level at Weeks 6, 12, and 18 after administration of the IP	1.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
Secondary	FPG level at Weeks 6, 12, 18, and 24 after administration of the IP	2.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
Secondary	HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP	3.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