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

Phase 3

Completed

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

• Registration Number: NCT04632862
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-11
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-17
• Primary Completion: 2021-11-25
• Study Completion: 2021-11-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-23
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP16001 Amg Placebo	DWP16001	DWP16001 Amg Placebo, Tablets, Orally, Once daily
DWP16001 Amg	DWP16001	DWP16001 Amg, Tablets, Orally, Once daily

Primary Outcome Measures

Name	Time	Method
HbA1c level at Week 24 after administration of the IP	at Week 24	1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP

Secondary Outcome Measures

Name	Time	Method
HbA1c level at Weeks 6, 12, and 18 after administration of the IP	at weeks 6, 12, and 18	1.Changes from Visit 2 (randomization) in HbA1c level at Weeks 6, 12, and 18 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	3.Proportions of subjects who achieved HbA1c level \< 7% 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	2.Changes from Visit 2 (randomization) in FPG level at Weeks 6, 12, 18, and 24 after administration of the IP

Trial Locations

Locations (1)

Daewoong pharmatceutical; 🇰🇷 Seoul, Korea, Republic of