UMIN-CTR Clinical Trial

Omarigliptin tended to elicit reductions in FBG, LDL-C, TG, AST, ALT, gamma-GTP, ACR with log ACR, and SBP and DBP, but the differences did not reach statistical significance compared with control. Values for HDL-C tended to increase, but also did not reach statistical significance compared with control. Omarigliptin significantly decreased HOMA-IR, RLP-C, and hsCRP with log hsCRP compared with control. However, omarigliptin did not affect HbA1c, BMI, and eGFR.

This single-center, open-label, randomized, prospective study included 84 patients who have attended our clinic for at least 12 months and had hemoglobin A1c (HbA1c) > 6.0% regardless of diet, exercise, and daily medication with the DPP4 inhibitors sitagliptin (50 mg) or linagliptin (5 mg). The patients were allocated in a 1:2 ratio using numbered containers to continue the same daily regimens of sitagliptin 50 mg (n = 19) or linagliptin 5 mg (n = 9) as a control group (n = 28) or to switch from these inhibitors (n = 40 and n = 16, respectively) to omarigliptin 25 mg/week (omarigliptin group: n = 56). 

Patients were allocated to continue with daily DPP4 inhibitors (control, n = 28) or to switch from daily DPP4 inhibitors to weekly omarigliptin (omarigliptin, n = 56). Fasting blood and urine samples were collected before, and every 3 months after intervention for 1 year.

None.

Blood and urine samples were collected from all included patients after an overnight fast at baseline and then at intervals of 3 months for 1 year. Values for hsCRP, IRI, RLP-C, and urinary albumin were assessed at LSI Medicine Corporation (Tokyo, Japan). Other biochemical data were generated in-house. HOMA-IR was calculated as (FBG * IRI)/450. The primary and secondary endpoints were changes among HbA1c, BMI, hsCRP, and HOMA-IR between baseline and 1 year later, and between baseline and 3-month intervals in the control and omarigliptin groups.