This study examined whether Ly 2963016 insulin glargine is safe and effective in type 2 diabetics.

Patients with type 2 diabetes (T2D) generally produce insulin but it fails to work in the body. T2D is a progressive disease, and over time, the pancreas reduces insulin production. T2D patients then require insulin therapy.

Insulin glargine (Lantus) is a long-acting insulin which diabetics inject once daily. It is responsible for lowering blood glucose 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 T2D patients in combination with oral anti-hypoglycemic agents such as metformin (Glucophage) and glipizide (Glucotrol). 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 in T2D patients. This trial involved 756 T2D patients. All participants recruited failed to produce insulin. 376 participants received Ly IGlar once daily for 24 weeks. 380 participants received IGlar once daily for 24 weeks. Patients also continued the oral anti-hypoglycemic treatments used prior to the start of the study. 

Participants receiving Ly IGlar had a similar decrease (-1.2%) in HbA1c (average blood glucose levels over 3 months) to those receiving IGlar (-1.34%). The proportion of patients achieving an HbA1c lower than 7% was similar in both groups after 24 weeks. The insulin dose was also similar in both groups. The number of patients experiencing side effects, allergic reactions, hypoglycemia (dangerously low blood glucose levels) and weight gain were similar in both groups.

This trial concluded that Ly IGlar and IGlar provide safe and effective control of blood glucose levels in T2D patients when administered with oral antihypoglycemic agents.

This trial was only carried out for 24 weeks. It would have been ideal to extend the study period to assess the long-term safety and effectiveness of Ly IGlar.

Although Ly IGlar is not yet available, you may consult your physician regarding the benefits of administering IGlar with oral anti-hypoglycemic agents.