Follow-on Biologic Insulin Glargine Candidate Similar to Lantus in Two Studies
Merck announced that two Phase 3 studies evaluating MK-1293, an investigational, follow-on biologic insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes, achieved their primary endpoints. Study data was presented for the first time at the 76th Scientific Sessions of the American Diabetes Association.
Both studies were randomized, active-controlled, open-label Phase 3 trials evaluating the efficacy and safety of MK-1293 vs. Lantus (insulin glargine; Sanofi Aventis) in patients with type 1 diabetes, in one study, and in patients with type 2 diabetes inadequately controlled on diet and exercise alone, in the second study. Patients enrolled had an A1C level ≤11% at baseline. The primary efficacy endpoint for both studies was non-inferiority of change from baseline A1C at week 24. A pre-specified secondary efficacy endpoint of statistical A1C equivalence to Lantus was also assessed.
Results from the two studies demonstrated non-inferiority in change from baseline A1C for MK-1293 in comparison to Lantus after 24 weeks, meeting the primary endpoint. In patients with type 1 diabetes, MK-1293 demonstrated non-inferiority to Lantus with a least-squares mean difference in A1C of 0.04% (95% CI: -0.11, 0.19). MK-1293 also demonstrated non-inferiority to Lantus in patients with type 2 diabetes, with a least-squares mean difference in A1C of 0.03% (95% CI: –0.12, 0.18). Both studies met the A1C non-inferiority (upper bound of the confidence interval <0.4%) and equivalence (confidence interval within –0.4% and 0.4%) criteria. Additionally, the pre-specified secondary efficacy endpoint was also met, showing that treatment with MK-1293 is similar, within an acceptable range, to a current therapy (Lantus).
The primary safety objective for the two studies was anti-insulin antibody (AIA) development. No clinically meaningful difference in safety endpoints, including AIA and symptomatic hypoglycemia, were seen between treatment groups.
MK-1293, Merck's follow-on biologic insulin glargine candidate, has the same amino acid sequence as Lantus, the originator insulin glargine. A follow-on biologic is a similar, but not identical, version of an approved reference product. MK-1293 is referred to as a follow-on biologic in the US due to its regulatory pathway.
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