Phase III Trial of SGLT2 Inhibitor and Thiazolidinedione Fixed-Dose Combination vs. Monotherapy in Type 2 Diabetes Patients on Metformin
408 patients around the world
Available in Brazil
This phase III clinical trial investigates a fixed-dose combination (FDC) of two
established antidiabetic medications with complementary mechanisms of action: an SGLT2
inhibitor and a thiazolidinedione (TZD). The study aims to evaluate whether combining
these medications in a single tablet provides superior glycemic control compared to
either medication alone in patients with type 2 diabetes who are already on metformin
therapy.
The SGLT2 inhibitor component lowers blood glucose by increasing urinary glucose
excretion, while the TZD component improves insulin sensitivity. Previous studies have
shown that these drug classes may offer complementary benefits for metabolic control and
cardiovascular risk reduction. However, the TZD component has been associated with side
effects including fluid retention and weight gain in some patients. This trial will
assess whether the combination can maintain the therapeutic benefits of both drugs while
potentially reducing TZD-related adverse effects.
The randomized, double-blind, double-dummy design compares three treatment arms: the FDC,
SGLT2 inhibitor monotherapy, and TZD monotherapy. The primary endpoint is the change in
HbA1c from baseline after 24 weeks of treatment. Secondary endpoints include measures of
safety, tolerability, and additional metabolic parameters.
Participants will undergo regular monitoring including blood tests, physical
examinations, and safety assessments throughout the study period. The trial includes
specific protocols for detecting and managing potential side effects, particularly those
related to fluid retention.
This study addresses an important clinical question regarding optimal treatment
strategies for type 2 diabetes, particularly the potential advantages of fixed-dose
combinations in simplifying treatment regimens while maintaining efficacy and safety. The
results may provide evidence for a new therapeutic option that combines the established
benefits of these two drug classes while potentially mitigating some limitations of
monotherapy approaches.
Eurofarma Laboratorios S.A.
1Research sites
408Patients around the world
This study is for people with
Diabetes
Diabetes mellitus type 2
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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.
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).