Last updated 40 days ago

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).
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.

Sites

Eurofarma Laboratorios S.A
Rod. Pres. Castello Branco, 3565 - Itaqui, Itapevi - SP, 06696-000
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