Status:
NOT_YET_RECRUITING
TRIGLYTZA® VERSUS METFORMIN IN OBESE ADULT TYPE 2 DIABETES (T2DM) PATIENTS OVER 24 WEEKS OF TREATMENT
Lead Sponsor:
Myopharm Limited
Conditions:
Type 2 Diabetes (T2DM)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 tre...
Detailed Description
Type 2 diabetes (T2DM) continues to be a major unmet medical need largely due to the currently marketed treatment options not adequately treating the underlying pathophysiology of immune mediated dama...
Eligibility Criteria
Inclusion
- 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
- 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
- FPG ≥140 mg/dL
- BMI ≥28 and ≤40
- 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
- eGFR ≥ 60 ml/min
Exclusion
- 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
- Subjects with a history of uncontrolled hyperglycemia (\>15.0 mmol/L) after an overnight fast that required rescue therapy
- Impaired kidney function defined as eGFR ≤60 mL/min
- Subjects taking any prohibited medications.
- Any of the following cardiovascular (CV)/vascular diseases within 3 months of the screening visit:
- Myocardial infarction (MI)
- Cardiac surgery or revascularization (coronary artery bypass surgery, Coronary Artery Bypass Graft \[(CABG\]/Percutaneous transluminal coronary angioplasty (PTCA)\]
- Unstable angina
- Unstable congestive heart failure (CHF)
- Transient ischemic attack (TIA) or significant cerebrovascular disease
- Unstable or previously diagnosed arrhythmia
- 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%.
- Acute coronary syndrome, stroke or transient ischemic attack within 3 months prior to the informed consent
- Previous bariatric surgery
- Previous bariatric surgery
- Treatment with anti-obesity drugs within 3 months prior to screening visit
- Subjects with COPD
- Subjects with active liver disease
- Subjects with active renal disease
- Subjects with autoimmune diseases e.g. Lupus, Psoriasis
- Subjects with HIV / AIDS
- Subjects with Hematological and Oncological Diseases/Conditions
- Haemoglobin \<11.0 g/dL (110 g/L) for men; haemoglobin \<10.0 g/dL (100 g/L) for women
- Subjects with chronic disease e.g. Cancer, Epilepsy, Alzheimer, Parkinson
- Subjects with abnormal free T4
- Subjects with serious active infection
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07139405
Start Date
February 1 2026
End Date
June 1 2028
Last Update
August 24 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.