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Clinical Trial
. 2024 Jul;26(7):2774-2786.
doi: 10.1111/dom.15596. Epub 2024 Apr 15.

Combination of retagliptin and henagliflozin as add-on therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin: A multicentre, randomized, double-blind, active-controlled, phase 3 trial

Yao Wang  1 , Chengxia Jiang  2 , Xiaolin Dong  3 , Mingwei Chen  4 , Qin Gu  5 , Lihui Zhang  6 , Yanqin Fu  7 , Tianrong Pan  8 , Yan Bi  9 , Weihong Song  10 , Jing Xu  11 , WeiPing Lu  12 , Xiaodong Sun  13 , Zi Ye  14 , Danli Zhang  14 , Liang Peng  14 , Xiang Lin  14 , Wei Dai  14 , Quanren Wang  14 , Wenying Yang  1
Affiliations
Clinical Trial

Combination of retagliptin and henagliflozin as add-on therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin: A multicentre, randomized, double-blind, active-controlled, phase 3 trial

Yao Wang et al. Diabetes Obes Metab. 2024 Jul.

Abstract

Aim: This study assessed the efficacy and safety of co-administering retagliptin and henagliflozin versus individual agents at corresponding doses in patients with type 2 diabetes mellitus who were inadequately controlled with metformin.

Methods: This multicentre, phase 3 trial consisted of a 24-week, randomized, double-blind, active-controlled period. Patients with glycated haemoglobin (HbA1c) levels between 7.5% and 10.5% were randomized to receive once-daily retagliptin 100 mg (R100; n = 155), henagliflozin 5 mg (H5; n = 156), henagliflozin 10 mg (H10; n = 156), co-administered R100/H5 (n = 155), or R100/H10 (n = 156). The primary endpoint was the change in HbA1c from baseline to week 24.

Results: Based on the primary estimand, the least squares mean reductions in HbA1c at week 24 were significantly greater in the R100/H5 (-1.51%) and R100/H10 (-1.54%) groups compared with those receiving the corresponding doses of individual agents (-0.98% for R100, -0.86% for H5 and -0.95% for H10, respectively; p < .0001 for all pairwise comparisons). Achievement of HbA1c <7.0% at week 24 was observed in 27.1% of patients in the R100 group, 21.2% in the H5 group, 24.4% in the H10 group, 57.4% in the R100/H5 group and 56.4% in the R100/H10 group. Reductions in fasting plasma glucose and 2-h postprandial glucose were also more pronounced in the co-administration groups compared with the individual agents at corresponding doses. Decreases in body weight and systolic blood pressure were greater in the groups containing henagliflozin than in the R100 group. The incidence rates of adverse events were similar across all treatment groups, with no reported episodes of severe hypoglycaemia.

Conclusions: For patients with type 2 diabetes mellitus inadequately controlled by metformin monotherapy, the co-administration of retagliptin and henagliflozin yielded more effective glycaemic control through 24 weeks compared with the individual agents at their corresponding doses.

Keywords: clinical trial; dipeptidyl peptidase‐4 inhibitor; metformin; sodium‐glucose cotransporter 2 inhibitor; type 2 diabetes mellitus.

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References

REFERENCES

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