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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07076056
Enrollment
230
Registered
2025-07-21
Start date
2022-10-27
Completion date
2024-06-19
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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

Interventions

DRUGDW1026C1

Sitagliptin 100mg+Empagliflozin 10mg

DRUGDW1026C2

Sitagliptin 100mg+Empagliflozin 25mg

DRUGDW1026S

Sitagliptin 100mg

Sponsors

Daewon Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
% change of HbA1c24 weeks% change of HbA1c in week 24 from baseline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026