Benefits and disadvantages of combination therapy with imeglimin and metformin in patients with type 2 diabetes.

Abstract

Background: We retrospectively examined the benefits and disadvantages of adding imeglimin to metformin therapy in patients with type 2 diabetes.

Research design and methods: Ninety-four patients with type 2 diabetes who had been administered imeglimin were included in the safety analysis set (SAS). Sixty-four patients who had been treated with imeglimin for over 6 months were included in the full analysis set (FAS). The primary outcome was the change in HbA1c levels in the FAS. The secondary outcomes were gastrointestinal adverse events (AEs) in the SAS and changes in body weight and FIB-4 in theFAS.

Results: In the SAS, gastrointestinal AEs occurred in 15 of 40 (38%) metformin users and 6 of 54 (11%) non-users. In the FAS, HbA1c levels were significantly reduced in both metformin users (n = 27, baseline, 8.5 ± 1.1%;6 months, 7.7 ± 1.2%) and non-users (n = 37, baseline, 8.0 ± 0.9%; 6 months,7.4 ± 0.9%). While body weight (from 72.0 ± 20.5 kg to 70.9 ± 20.8 kg) and FIB-4 (from 1.27 ± 0.57 to 1.17 ± 0.49) significantly decreased in metformin users, they did not significantly differ in non-users.

Conclusions: Adding imeglimin to metformin therapy demonstrated favorable reductions in HbA1c, body weight, and FIB-4 in patients with type 2 diabetes, although it was associated with the incidence of gastrointestinal AEs.

Trial registration: UMIN000055241.