NCT07076056

Brief Summary

A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase III Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2 Add-on to Metformin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin and Sitagliptin Combination Therapy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2025

Completed
Last Updated

July 21, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

July 13, 2025

Last Update Submit

July 13, 2025

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • % change of HbA1c

    % change of HbA1c in week 24 from baseline

    24 weeks

Study Arms (3)

DW1026C1 & DW1026C2 placebo & DW1026S placebo

EXPERIMENTAL
Drug: DW1026C1

DW1026C1 placebo & DW1026C2 & DW1026S placebo

EXPERIMENTAL
Drug: DW1026C2

DW1026C1 placebo & DW1026C2 placebo & DW1026S

PLACEBO COMPARATOR
Drug: DW1026S

Interventions

DW1026C1DRUG

Sitagliptin 100mg+Empagliflozin 10mg

DW1026C1 & DW1026C2 placebo & DW1026S placebo
DW1026C2DRUG

Sitagliptin 100mg+Empagliflozin 25mg

DW1026C1 placebo & DW1026C2 & DW1026S placebo
DW1026SDRUG

Sitagliptin 100mg

DW1026C1 placebo & DW1026C2 placebo & DW1026S

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are diagnosed with Type2 Diabetes
  • ≤ Age ≤ 85
  • % ≤ HbA1c ≤ 10.5%

You may not qualify if:

  • Patients with a history of acute pancreatitis
  • Patients with a history of pre-diabetic coma
  • Patients with a history of diagnosis of malignant tumors within 5 years prior to visit 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeouido St. Mary's Hospital The Catholic University

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2025

First Posted

July 21, 2025

Study Start

October 27, 2022

Primary Completion

December 4, 2023

Study Completion

June 19, 2024

Last Updated

July 21, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)