Is omarigliptin safe and effective in insulin-treated patients with uncontrolled type 2 diabetes?

This study looked at the use of omarigliptin (Marizev) in insulin-treated patients with uncontrolled type 2 diabetes (T2D). It found that omarigliptin was well-tolerated and improved blood glucose control. 

Type 2 diabetes (T2D) is usually treated initially with diet, exercise, and medications like metformin (Glucophage). If this is not enough to lower blood glucose, then insulin treatment is started. However, there are still patients who do not manage to control their blood glucose even on insulin treatment. In these patients, it is not clear what the next step should be.  

Omarigliptin is a newer blood glucose-lowering medication that increases natural insulin production in the body. Omarigliptin may be a useful additional treatment for patients who are poorly controlled on insulin. However, its safety and effectiveness in these patients are still under investigation.

This study involved 184 poorly controlled, patients with T2D taking insulin. 123 patients were randomly given omarigliptin for 16 weeks, while 61 patients were given a placebo. After 16 weeks, both groups were given omarigliptin for another 36 weeks. HbA1c which is a measure of blood glucose control over 2-3 months was measured at the start, after 16 weeks, and at the end of the study.

After 16 weeks, the patients treated with omarigliptin showed a reduction in HbA1c of 0.61%, while those treated with placebo had an increase of 0.29%. 5.8% in the omarigliptin group reached a target HbA1c below 7% compared to 0% in the placebo group. 

After another 36 weeks in which both groups received omarigliptin, both groups showed a reduction in HbA1c levels of 0.57%. Patients who switched from placebo to omarigliptin reached similar HbA1c levels as those treated with omarigliptin from the beginning after 52 weeks. 

 The overall occurrence of side effects was similar between groups.  

This study showed that the addition of omarigliptin to insulin treatment was well-tolerated and resulted in an improvement in diabetic control.

This study involved Japanese patients only.  More studies are needed to see if these findings apply to other ethnicities. This study was funded by Merck, the manufacturer of omarigliptin.