Triple Therapy: GEMI + DAPA Enhances Glycemic Control for Type 2 Diabetics on Metformin, SOLUTION 2 study
South Korea: Gemigliptin and dapagliflozin dual add-on therapy (GEMI+DAPA) along with metformin is safe, effective, and well-tolerated, particularly for type 2 diabetes (T2D) patients with poor glycemic control on metformin alone, the SOLUTION 2 study has shown.
The findings, published in Diabetes, Obesity and Metabolism, suggest that the triple combination therapy provides robust glycemic control without notable safety concerns.
Kyong Soo Park, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea, and colleagues conducted the study to evaluate the safety and efficacy of gemigliptin and dapagliflozin dual add-on therapy to metformin in T2D patients who had inadequate glycaemic control on metformin alone, compared with a single add-on of either gemigliptin (GEMI) or dapagliflozin (DAPA) to metformin.
The randomized, double-blind, double-dummy, active-controlled, parallel-group, phase 3 study (SOLUTION 2) included 469 type 2 diabetes patients treated with a stable metformin dose for eight weeks or longer. They were randomized to receive GEMI + DAPA (n = 157) and either GEMI (n = 156) or DAPA (n = 156). The main focus of the study was to measure the difference in HbA1c levels from baseline after 24 weeks of treatment.
The following were the key findings of the study:
- Baseline characteristics, including body mass index and T2D duration, were similar among groups.
- At week 24, the least square mean changes in HbA1c from baseline were −1.34% with GEMI + DAPA, −0.90% with GEMI (difference between GEMI + DAPA versus GEMI −0.44%) and −0.78% with DAPA (difference between GEMI + DAPA versus DAPA −0.56%).
- Both upper CIs were less than 0, demonstrating the superiority of GEMI + DAPA for lowering HbA1c.
- The rates of responders achieving HbA1c less than 7% and less than 6.5% were greater with GEMI + DAPA (84.9%, 56.6%) than with GEMI (55.3%, 32.2%) and DAPA (49.3%, 15.3%).
- The incidence rate of adverse events was similar across groups, with low incidence rates of hypoglycemia, urinary tract infection, and genital infection.
As diabetes continues to pose a global health challenge, innovative treatment strategies like the dual add-on therapy of gemigliptin and dapagliflozin presented in the SOLUTION 2 study offer renewed optimism for improved patient outcomes. With further research and clinical validation, this approach could potentially redefine standards of care in managing type 2 diabetes, ushering in a new era of personalized and effective treatment options.
"The SOLUTION 2 study provides compelling evidence supporting the efficacy, safety, and holistic benefits of combining gemigliptin and dapagliflozin for patients with inadequately controlled type 2 diabetes, marking a significant advancement in diabetes therapeutics," the researchers concluded.
Reference:
Han KA, Hwang YC, Moon SJ, Cho HC, Yoo HJ, Choi SH, Chon S, Kim KA, Kim TN, Kang JG, Park CY, Won JC, Cho E, Kim J, Park KS. Dual add-on therapy of gemigliptin and dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone: The SOLUTION 2 study. Diabetes Obes Metab. 2024 Jul 8. doi: 10.1111/dom.15717. Epub ahead of print. PMID: 38978173.
