A generic alternative to Lantus for type 1 diabetics

This study examined whether Ly 2963016 insulin glargine is safe and effective in type 1 diabetics.

Insulin glargine (Lantus) is a long-acting insulin which diabetics inject once daily. It is responsible for lowering blood glucose (sugar) levels over a 24 hour period. Insulin glargine (IGlar) was first developed in 1982. However, generic versions (similar but cheaper form of drug) may be developed in order to reduce costs. Ly 2963016 insulin glargine (Ly IGlar) is a generic alternative to IGlar which may be administered to patients with type 1 diabetes (T1D) in combination with insulin lispro (novorapid) at mealtimes. It has a similar form and strength as IGlar. However, the safety and effectiveness of this drug must be established before its use can be approved.

This trial aimed to determine whether Ly IGlar has a similar safety and effectiveness profile as IGlar.

This trial involved 535 T1D patients. 268 participants received Ly IGlar, while 267 participants received IGlar. Both drugs were taken along with insulin lispro at mealtimes. Patients received the same insulin dose as they had before beginning the study. Patients were followed up 10 times over a 1 year period.

Participants receiving Ly IGlar had a similar decrease (-0.35%) in HbA1c (average blood glucose levels over 3 months) to those receiving IGlar (-0.46%). The daily mean blood glucose levels were also similar between both groups after 24 weeks and 52 weeks. The number of patients experiencing side effects, allergic reactions and hypoglycaemia (dangerously low blood glucose levels) were similar in both groups.

This trial concluded that Ly IGlar and IGlar provide safe and effective control of blood glucose levels when administered with insulin lispro.

The investigators were aware which drug each participant received, which could influence results.

Although Ly IGlar is not yet available, you may consult your physician regarding the benefits of administering IGlar with insulin lispro.