Clinical Trial to Evaluate the Efficacy and Safety of DW1026C1 or DW1026C2

NCT ID: NCT07076056

Last Updated: 2025-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2024-06-19

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DW1026C1 & DW1026C2 placebo & DW1026S placebo

Group Type EXPERIMENTAL

DW1026C1

Intervention Type DRUG

Sitagliptin 100mg+Empagliflozin 10mg

DW1026C1 placebo & DW1026C2 & DW1026S placebo

Group Type EXPERIMENTAL

DW1026C2

Intervention Type DRUG

Sitagliptin 100mg+Empagliflozin 25mg

DW1026C1 placebo & DW1026C2 placebo & DW1026S

Group Type PLACEBO_COMPARATOR

DW1026S

Intervention Type DRUG

Sitagliptin 100mg

Interventions

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DW1026C1

Sitagliptin 100mg+Empagliflozin 10mg

Intervention Type DRUG

DW1026C2

Sitagliptin 100mg+Empagliflozin 25mg

Intervention Type DRUG

DW1026S

Sitagliptin 100mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are diagnosed with Type2 Diabetes
* 19 ≤ Age ≤ 85
* 7.0% ≤ HbA1c ≤ 10.5%

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yeouido St. Mary's Hospital The Catholic University

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW1026-301

Identifier Type: -

Identifier Source: org_study_id

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