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Completed

NCT Number: NCT07076056

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yeouido St. Mary's Hospital The Catholic University

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DW1026C1

Drug

Sitagliptin 100mg+Empagliflozin 10mg

DW1026C2

Drug

Sitagliptin 100mg+Empagliflozin 25mg

DW1026S

Drug

Sitagliptin 100mg

Primary outcomes

  1. % change of HbA1c

    Time frame: 24 weeks

    % change of HbA1c in week 24 from baseline

Sponsors and collaborators

Lead sponsor

Daewon Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 21, 2025
Registry last updated
Jul 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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