Trial results for a study investigating Type 2 Diabetes were posted on ClinicalTrials.gov on 2025-05-22, with 88 participants enrolled.
Background
Type 2 Diabetes is a chronic condition characterized by insulin resistance and relative insulin deficiency, leading to elevated blood glucose levels. Metformin is a widely used first-line medication for its efficacy in reducing hepatic glucose production and improving insulin sensitivity. Dapagliflozin, an SGLT2 inhibitor, works by increasing glucose excretion through the kidneys, offering an additional mechanism to lower blood sugar. This study aimed to evaluate the impact of adding dapagliflozin to metformin therapy in newly diagnosed patients, particularly focusing on glycemic variability and other metabolic parameters, which are crucial for long-term diabetes management and preventing complications.
Trial design
This completed Phase 3 study enrolled 88 participants with Type 2 Diabetes. The trial compared the effect of Dapagliflozin (10 mg/day) added to Metformin (2000 mg/day) versus Metformin alone (2000 mg/day) over a 12-week period. The study aimed to assess differences in blood sugar fluctuations and overall blood glucose control between the two treatment regimens in adults with a recent diagnosis of Type 2 Diabetes.
Key results
The trial reported several key measurements comparing the combination therapy of Dapagliflozin plus Metformin to Metformin alone over 12 weeks:
- ΔHbA1c (change in percentage of HbA1c):
- Dapagliflozin + Metformin group showed a mean change of -1.8 percentage of HbA1c.
- Metformin alone group showed a mean change of -1.6 percentage of HbA1c.
- ΔMAGE (change in Mean Amplitude of Glycemic Excursions, in mmol/dL):
- Dapagliflozin + Metformin group showed a mean change of -0.8 mmol/dL.
- Metformin alone group showed a mean change of 0.0 mmol/dL.
- Δweight (change in kg):
- Dapagliflozin + Metformin group showed a mean change of -2.7 kg.
- Metformin alone group showed a mean change of -0.7 kg.
- ΔTIR %Target 70-180 mg/dL (change in percentage of time in target range):
- Dapagliflozin + Metformin group showed a mean change of 31.5 percentage of time.
- Metformin alone group showed a mean change of 0.4 percentage of time.
- Δinsulin (change in uU/mL):
- Dapagliflozin + Metformin group showed a mean change of -2.5 uU/mL.
- Metformin alone group showed a mean change of 0.4 uU/mL.
- Δsystolic Blood Pressure (change in mm/Hg):
- Dapagliflozin + Metformin group showed a mean change of -2.0 mm/Hg.
- Metformin alone group showed a mean change of 0.0 mm/Hg.
What this means
The results suggest that adding dapagliflozin to metformin therapy in newly diagnosed Type 2 Diabetes patients may offer additional benefits beyond metformin monotherapy. The combination treatment led to a greater reduction in HbA1c, a more significant decrease in glycemic variability (ΔMAGE), and a substantial increase in time in the target glucose range (ΔTIR). Furthermore, patients receiving combination therapy experienced greater weight loss and a reduction in systolic blood pressure, which are important secondary benefits for individuals with Type 2 Diabetes. These findings indicate that early initiation of combination therapy with dapagliflozin and metformin could provide more comprehensive glycemic control and cardiometabolic improvements.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04090580, titled "Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone", were posted on 2025-05-22 on clinicaltrials.gov.