Type 2 diabetes (T2DM) is still very difficult to treat because current medicines mostly help with symptoms but don't stop the damage happening inside the pancreas. Many people who start on common treatments like Metformin, and even newer drugs like Ozempic, eventually stop responding to them. This is because these drugs don't address the real problem: the gradual loss of the pancreas' ability to make insulin and the body's increasing resistance to it.
Myopharm is developing a new treatment called TriGlytza®, which combines existing medicines (Celecoxib and Valsartan) with Metformin. This new approach is designed to target the inflammation and biological pathways that cause ongoing damage in Type 2 diabetes, aiming to protect the pancreas and reduce insulin resistance. Early animal studies and past clinical trials with the individual drugs show promising results.
The number of people with Type 2 diabetes is expected to double by 2045, and the disease brings huge health and financial costs. It also raises the risk of heart disease, stroke, kidney damage, nerve problems, vision loss, certain cancers, and even conditions like Alzheimer's. Because of this, a treatment that addresses the root causes rather than just symptoms could make a major difference.
TriGlytza® aims to provide a safe, affordable, and more effective long-term treatment than current options, helping people manage their diabetes better and avoid related health problems.
Males and females, age 18 and ≤70 at time of screening visit
WOCBP must have negative serum or urine pregnancy test (min sensitivity 25 IU/L or equivalent HCG) within 24 hours prior to the start of the study
Women must not be breastfeeding
Inadequate BG control with Metformin defined as a screening HbA1c of ≥7.0 and ≤ 10.5 at the screening visit
Patients with Type 1 Diabetes
Patients with history of ketoacidosis
Subjects at serious risk of GI adverse events per the discretion of the study site investigator (e.g current or recent history of GI bleeding ulceration, or perforation)
Subjects with a planned radiologic study with IV contrast, surgery, or other planned procedures that may predispose them to metformin-associated lactic acidosis
Parallel
Metformin XR 1000mg
DrugArm 1: Metformin XR 1000mg Monotherapy (taken AM)
Valsartan 80mg Tablet
DrugArm 2: Valsartan 80mg (taken PM)
Valsartan 160mg tablet
DrugArm 3: Valsartan 160mg (taken PM)
Celecoxib (Celebrex®) 100mg
DrugArm 2: Celecoxib 100mg (taken AM)
Celecoxib (Celebrex®) 200mg
DrugArm 3: Celecoxib (taken AM)
Metformin XR 500 mg
DrugArm 2: Metformin 500mg (taken AM)
To demonstrate that after 24 weeks of treatment, the mean improved change in glycemic response from baseline, measured through mean reduction in HbA1c levels, for TriGlytza™ is superior to Metformin monotherapy.
Mean change in HbA1c from baseline to Treatment Week 24.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
