NCT05743907CompletedPhase 4
Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control
Source: ClinicalTrials.gov · Last updated 14 Mar 2025
Brief summary (registry, in English)
This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 231 (actual)
- First submitted
- 15 Feb 2023
- Start date
- 25 Apr 2023
- Primary completion date
- 10 Mar 2025
- Lead sponsor
- Dong-A ST Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT05743907
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 231
- From 25 Apr 2023 to the primary completion date, 10 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening
Other illness
- Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
Lab values
- Subjects with fasting plasma glucose≥240mg/dL at screening
- Subject with ALT and AST 3 times or higher than upper normal range
Who the study is looking for
- Subjects with 7.0%≤HbA1c≤10.0% at screening
- Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening
- Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
- Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Catholic University of Korea, Bucheon St. Mary's Hospital Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.