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

Phase 3

Completed

• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Interventions: Drug: DWP16001 Amg

• Registration Number: NCT04654390
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Study Start: 2020-12-30
• Primary Completion: 2021-12-17
• Study Completion: 2021-12-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP16001 Amg placebo, Dapagliflozin Bmg	DWP16001 Amg	Tablets, Orally, Once daily
DWP16001 Amg, Dapagiflozin Bmg placebo	DWP16001 Amg	Tablets, Orally, Once daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

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