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- Title
Dual add‐on therapy of gemigliptin and dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone: The SOLUTION 2 study.
- Authors
Han, Kyung Ah; Hwang, You‐Cheol; Moon, Shin Je; Cho, Ho Chan; Yoo, Hye Jin; Choi, Sung Hee; Chon, Suk; Kim, Kyoung‐Ah; Kim, Tae Nyun; Kang, Jun Goo; Park, Cheol‐Young; Won, Jong Chul; Cho, Eunjoo; Kim, Jeongyun; Park, Kyong Soo
- Abstract
Aim: To evaluate the efficacy and safety of gemigliptin and dapagliflozin dual add‐on therapy (GEMI + DAPA) to metformin in type 2 diabetes (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. Materials and Methods: In this randomized, double‐blind, double‐dummy, active‐controlled, parallel‐group, phase 3 study, 469 T2D patients treated with a stable dose of metformin for 8 weeks or longer were randomized to receive GEMI + DAPA (n = 157) and either GEMI (n = 156) or DAPA (n = 156). The primary endpoint was change in HbA1c levels from baseline at week 24. Results: 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 vs. GEMI −0.44% [95% confidence interval {CI}: −0.58% to −0.31%], P <.01) and −0.78% with DAPA (difference between GEMI + DAPA vs. DAPA −0.56% [95% CI: −0.69% to −0.42%], P <.01). 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 hypoglycaemia, urinary tract infection and genital infection. Conclusions: These results suggest that the addition of GEMI + DAPA to metformin as triple combination therapy was effective, safe and well‐tolerated, especially for T2D patients who experienced poor glycaemic control on metformin alone.
- Subjects
TYPE 2 diabetes; GLYCEMIC control; URINARY tract infections; GENITALIA infections; BODY mass index
- Publication
Diabetes, Obesity & Metabolism, 2024, Vol 26, Issue 9, p3743
- ISSN
1462-8902
- Publication type
Article
- DOI
10.1111/dom.15717