---
title: The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.
nct_id: NCT04632862
overall_status: COMPLETED
phase: PHASE3
sponsor: Daewoong Pharmaceutical Co. LTD.
study_type: INTERVENTIONAL
primary_condition: T2DM (Type 2 Diabetes Mellitus)
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04632862.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04632862"
ct_last_update_post_date: 2022-10-25
last_seen_at: "2026-05-12T07:00:43.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.

**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

**NCT ID:** [NCT04632862](https://clinicaltrials.gov/study/NCT04632862)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 140
- **Lead Sponsor:** Daewoong Pharmaceutical Co. LTD.
- **Conditions:** T2DM (Type 2 Diabetes Mellitus)
- **Start Date:** 2020-11-11
- **Completion Date:** 2021-11-25
- **CT.gov Last Update:** 2022-10-25

## 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.

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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)
```

## Arms

- **DWP16001 Amg** (EXPERIMENTAL) — DWP16001 Amg, Tablets, Orally, Once daily
- **DWP16001 Amg Placebo** (PLACEBO_COMPARATOR) — DWP16001 Amg Placebo, Tablets, Orally, Once daily

## Interventions

- **DWP16001** (DRUG) — DWP16001 A mg

## Primary Outcomes

- **HbA1c level at Week 24 after administration of the IP** _(time frame: at Week 24)_ — 1.Change from Visit 2 (randomization) in HbA1c level at Week 24 after administration of the IP

## Secondary Outcomes

- **HbA1c level at Weeks 6, 12, and 18 after administration of the IP** _(time frame: at weeks 6, 12, and 18)_
- **FPG level at Weeks 6, 12, 18, and 24 after administration of the IP** _(time frame: at weeks 6, 12, 18, and 24)_
- **HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP** _(time frame: at weeks 6, 12, 18, and 24)_

## Locations (1)

- Daewoong pharmatceutical, Seoul, South Korea

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.daewoong pharmatceutical|seoul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04632862.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04632862*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*