TRIGLYTZA® VERSUS METFORMIN IN OBESE ADULT TYPE 2 DIABETES (T2DM) PATIENTS OVER 24 WEEKS OF TREATMENT

Launched by MYOPHARM LIMITED · Aug 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called TriGlytza® for adults with type 2 diabetes who are also overweight or obese. TriGlytza® combines three medicines, including Metformin, to not just manage blood sugar levels but also to protect the pancreas—the organ that makes insulin—and reduce the body’s resistance to insulin. This is important because most current treatments help with symptoms but don’t stop the damage inside the pancreas, which can make diabetes harder to control over time. The goal of this trial is to see if TriGlytza® is a safe and better long-term option for managing type 2 diabetes compared to Metformin alone.

People who may be eligible to join are adults between 18 and 70 years old who have type 2 diabetes that is not well controlled with Metformin alone, meaning their blood sugar levels are higher than recommended. They should be overweight, with a body mass index (BMI) between 28 and 40, and have mild high blood pressure that is either untreated or well-controlled with medication. Women who can become pregnant need to have a negative pregnancy test and not be breastfeeding. Participants should not have serious health problems like type 1 diabetes, recent heart issues, kidney problems, or certain infections. If you join the study, you can expect to be monitored closely over 24 weeks to see how well the new treatment works and to check for any side effects. This trial aims to find a more effective and affordable treatment that could help people with type 2 diabetes manage their condition better and avoid related health issues in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females, age 18 and ≤70 at time of screening visit
• • 2. 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
• • 3. Women must not be breastfeeding
• • 4. Inadequate BG control with Metformin defined as a screening HbA1c of ≥7.0 and ≤ 10.5 at the screening visit
• • 5. Subjects should have been taking the same daily dose of Metformin for at least 8 weeks prior to the enrolment visit and subjects must not receive other antihyperglycemic medications within the 12 weeks prior to screening
• • 6. FPG ≥140 mg/dL
• • 7. BMI ≥28 and ≤40
• • 8. Grade 1 hypertension defined as 140-159 systolic and 90-99 diastolic mmHg if patients is not receiving anti-hypertensive medication at the time of screening / or has never received anti-hypertensive medication.
• • If patient is receiving anti-hypertensive medication at the time of screening and their BP is controlled, BP should be within the normal range of \<120-139 systolic and \<80-89 diastolic.
• • Patients receiving anti-hypertensive medication at the time of screening and for which their hypertension is uncontrolled, will be excluded
• • 9. eGFR ≥ 60 ml/min
• Exclusion Criteria:
• • 1. Patients with Type 1 Diabetes
• • 2. Patients with history of ketoacidosis
• • 3. 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)
• • 4. Subjects with a planned radiologic study with IV contrast, surgery, or other planned procedures that may predispose them to metformin-associated lactic acidosis
• • 5. Subjects with a history of uncontrolled hyperglycemia (\>15.0 mmol/L) after an overnight fast that required rescue therapy
• • 6. Impaired kidney function defined as eGFR ≤60 mL/min
• • 7. Subjects taking any prohibited medications.
• 8. Any of the following cardiovascular (CV)/vascular diseases within 3 months of the screening visit:
• • 1. Myocardial infarction (MI)
• • 2. Cardiac surgery or revascularization (coronary artery bypass surgery, Coronary Artery Bypass Graft \[(CABG\]/Percutaneous transluminal coronary angioplasty (PTCA)\]
• • 3. Unstable angina
• • 4. Unstable congestive heart failure (CHF)
• • 5. Transient ischemic attack (TIA) or significant cerebrovascular disease
• • 6. Unstable or previously diagnosed arrhythmia
• • 7. Congestive heart failure, defined as New York Heart Association (NYHA) Class III and IV, unstable or acute heart failure and/or known left ventricular ejection fraction of ≤40%.
• • 8. Acute coronary syndrome, stroke or transient ischemic attack within 3 months prior to the informed consent
• • 9. Previous bariatric surgery
• • 10. Previous bariatric surgery
• • 11. Treatment with anti-obesity drugs within 3 months prior to screening visit
• • 12. Subjects with COPD
• • 13. Subjects with active liver disease
• • 14. Subjects with active renal disease
• • 15. Subjects with autoimmune diseases e.g. Lupus, Psoriasis
• • 16. Subjects with HIV / AIDS
• • 17. Subjects with Hematological and Oncological Diseases/Conditions
• • 18. Haemoglobin \<11.0 g/dL (110 g/L) for men; haemoglobin \<10.0 g/dL (100 g/L) for women
• • 19. Subjects with chronic disease e.g. Cancer, Epilepsy, Alzheimer, Parkinson
• • 20. Subjects with abnormal free T4
• • 21. Subjects with serious active infection