Combination therapies of basal insulin with either vildagliptin or lixisenatide are similarly effective at producing glycemic control improvements, according to a study published in Diabetes Therapy.

Researchers in this open-label, randomized, parallel-group, multicenter study comprehensively evaluated the effects of combination therapy with basal insulin and the incretin-based drugs vildagliptin or lixisenatide on Japanese participants with type 2 diabetes who had inadequate glycemic control (7.0% to 10.0%) with insulin glargine and sitagliptin combination therapy. At the start of the 12-week study, participants (N=38) were randomly switched to vildagliptin (100 mg/day, n=20) or lixisenatide (20 µg/day, n=18). 

After the switch, insulin dosage was titrated to maintain an approximate 110 mg/dL fasting blood glucose. Primary study endpoints were the proportion of participants achieving HbA1c levels below 7.0%, the change in HbA1c levels from baseline to 12 weeks after medication switch, and the increase in self-monitored postprandial glucose concentration. Secondary endpoints included changes in body weight, low-density lipoprotein (LDL)-cholesterol, and treatment satisfaction, among other factors.

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Neither the proportion of patients achieving an HbA1c below 7.0% nor the change in HbA1c from baseline to 12 weeks differed significantly between the vildagliptin and lixisenatide groups (-0.6±1.2% and -0.6±0.7%, respectively; P =.920). The increase in postprandial glucose concentration was also not significantly different between the two treatment groups. Body weight decreased significantly in the lixisenatide group (P =.036), and LDL-cholesterol levels decreased significantly in the vildagliptin group (P =.044).

For treatment safety parameters, vildagliptin was associated with serum aspartate transaminase elevation (P =0.33). Neither treatment group reported severe hypoglycemia but both medications were associated with mild gastrointestinal symptoms. At 12 weeks, treatment satisfaction did not significantly differ between groups.

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Study investigators concluded that “combination therapy with insulin glargine and either lixisenatide or vildagliptin led to similar improvements in glycemic control in patients with type 2 diabetes. Further studies are required to determine whether these findings are generalizable to patients with different backgrounds.”

Multiple authors report receiving various fees and support from the pharmaceutical industry. Refer to reference for complete disclosure information.


Otowa-Suematsu N, Sakaguchi K, Nakamura T, et al. Comprehensive evaluation of combination therapy with basal insulin and either lixisenatide or vildagliptin in Japanese patients with type 2 diabetes: a randomized, open-label, parallel-group, multicenter study [published online September 11, 2018]. Diabetes Ther. doi:10.1007/s13300-018-0505-2