Evaluating Pioglitazone with Empagliflozin and Metformin for Type 2 Diabetes
A Multicentre, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Pioglitazone Co-administration in Patients with Type II Diabetes with Insufficient Glycemic Control with Metformin and Empagliflozin Combination Therapy
This study tests whether adding pioglitazone to the diabetes medications empagliflozin and metformin can help people with Type 2 Diabetes manage their blood sugar better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 582 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Celltrion Industry-sponsored |
| Locations | 1 site (Incheon) |
| Trial ID | NCT06571591 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial aims to assess the efficacy and safety of a combination therapy involving pioglitazone in patients with Type 2 Diabetes Mellitus (T2DM) who are already receiving treatment with empagliflozin and metformin. The study will involve multiple groups, including those receiving the new treatment and a placebo, to determine how well the combination works in improving glycemic control. Participants will be closely monitored for both effectiveness and any potential side effects throughout the trial period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with Type 2 Diabetes who are currently on a regimen of empagliflozin and metformin but are experiencing insufficient glycemic control.
Not a fit: Patients with other types of diabetes or those with uncontrolled severe complications of diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide improved glycemic control for patients with Type 2 Diabetes who are not adequately managed with their current medications.
How similar studies have performed: Other studies have shown promising results with combination therapies for Type 2 Diabetes, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults at the time of signing the Informed Consent Form (ICF) * Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study * Diagnosed with T2DM Exclusion Criteria: * Diagnosed with other types of diabetes than T2DM * History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy * Uncontrolled severe complications of diabetes
Where this trial is running
Incheon
- Celltrion — Incheon, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Celltrion, Inc.
- Email: hyunjung.lee4@celltrion.com
- Phone: +82 32 850 5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.