NCT05504226CompletedPhase 3
Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin
A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin 25 mg
Source: ClinicalTrials.gov · Last updated 27 Jan 2025
Brief summary (registry, in English)
The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin 25 mg and metformin
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 214 (actual)
- First submitted
- 11 Aug 2022
- Start date
- 12 Oct 2022
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Handok Inc.
- Diseases
- Type 2 diabetes
- NCT number
- NCT05504226
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 214
- From 12 Oct 2022 to the primary completion date, 30 Nov 2023
- 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
- Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
- Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
Other illness
- Subjects with type 1 diabetes mellitus or secondary diabetes
- Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment
Other
- Body mass index greater than 40 kg/m2 at the screening visit
Who the study is looking for
- Patients with Type II diabetes mellitus aged 19 years or older
- Subjects with 7.0%≤HbA1c≤10.5% at screening visit
- Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.