---
title: The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.
nct_id: NCT04634500
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/NCT04634500.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04634500"
ct_last_update_post_date: 2022-10-25
last_seen_at: "2026-05-12T06:32:07.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes.

**Official Title:** Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

**NCT ID:** [NCT04634500](https://clinicaltrials.gov/study/NCT04634500)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Daewoong Pharmaceutical Co. LTD.
- **Conditions:** T2DM (Type 2 Diabetes Mellitus)
- **Start Date:** 2020-11-18
- **Completion Date:** 2021-11-03
- **CT.gov Last Update:** 2022-10-25

## Brief Summary

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

## Detailed Description

A Multi-center, Randomized, Double-Blind, Active-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.

## Eligibility

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

```
Inclusion Criteria:

1. Subjects with T2DM aged 19 to 80 years
2. Subjects who have received metformin alone at a fixed dose for the last 8 weeks and has 7% ≤ HbA1c ≤ 10.5%
3. Subjects with BMI of 20-45 kg/m2
4. 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. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
2. Diabetic ketoacidosis, diabetic coma or precoma within the past year
3. Urinary tract infections or genital infections within
4. Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg)
5. eGFR \< 60 mL/min/1.73 m2
6. Severe heart failure (NYHA class III/IV)
```

## Arms

- **Study group** (EXPERIMENTAL) — DWP16001 A mg, Dapagliflozin placebo
- **Control group** (ACTIVE_COMPARATOR) — DWP16001 A mg placebo, Dapagliflozin

## Interventions

- **Dapagliflozin** (DRUG) — Dapagliflozin Tablet

## Primary Outcomes

- **Change from baseline in HbA1c** _(time frame: at 24 weeks)_

## Locations (1)

- Daewoong pharmatceutical, Soeul, South Korea

## Recent Field Changes (last 30 days)

- `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)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — 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|soeul||south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04634500.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04634500*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*