Phase III Trial of SGLT2 Inhibitor and Thiazolidinedione Fixed-Dose Combination vs. Monotherapy in Type 2 Diabetes Patients on Metformin

Launched by EUROFARMA LABORATORIOS S.A. · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new diabetes treatment that combines two medicines into one pill for people with type 2 diabetes who are already taking metformin. One medicine helps the body get rid of extra sugar through urine, while the other helps the body use insulin better. The study wants to find out if this combined pill controls blood sugar better than taking each medicine separately, and if it causes fewer side effects like weight gain or swelling.

Adults with type 2 diabetes who have blood sugar levels that are a bit high (measured by a test called HbA1c between 7.5% and 10%) despite taking metformin for at least three months may be able to join. Participants will be randomly assigned to take either the new combined pill or one of the two medicines alone, and they will visit the clinic regularly so doctors can check their blood sugar, weight, and any side effects. This study could offer a simpler and more effective treatment option for people managing type 2 diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent form
• • Age ≥18 years
• • Diagnosis of type 2 diabetes (T2DM)
• • HbA1c 7.5-10% while on stable metformin monotherapy (≥1000 mg/day) for ≥12 weeks
• • ≥80% adherence to run-in medication
• Exclusion Criteria:
• • Type 1 diabetes or other specific diabetes types (e.g., monogenic, pancreatic, or drug-induced)
• • Severe hyperglycemia (≥270 mg/dL) or diabetic ketoacidosis in past 12 weeks
• • Hypersensitivity to study drugs or excipients
• • Pregnancy, lactation, or planning pregnancy
• • Severe diabetic complications (proliferative retinopathy, severe neuropathy)
• • Major cardiovascular events in past 12 weeks (e.g., myocardial infarction, heart failure NYHA III/IV)
• • Uncontrolled hypertension (SBP \>180 mmHg or DBP \>110 mmHg)
• • Moderate/severe renal impairment (eGFR \<45 mL/min/1.73m²)
• • Liver disease (cirrhosis, active hepatitis)
• • History of malignancy (except treated skin cancers) in past 5 years
• • Use of non-metformin antidiabetics or weight-loss drugs in past 12 weeks