Insulin Combination May Reduce Burden on Patients With Type 1 Diabetes

Adocia, a clinical biopharmaceutical company, recently announced positive results from a phase 1b clinical trial that assessed the effects of the BioChaperone Combo in patients with type 1 diabetes after meals.

BioChaperone Combo is a combination of long-acting insulin analog glargine (Lantus) and fast-acting insulin analog lispro (Humalog). BioChaperone technology solubilizes insulin glargine at neutral pH, making it compatible with fast-acting insulin analogs, according to a press release.

“This clinical data for BioChaperone Combo demonstrates a statistically significant improvement over current premix, even in a limited number of people with type 2 diabetes, in terms of both the postprandial glucose excursion and the number of hypoglycemic events,” said Steve Edelman, MD. “This new combination of basal and prandial insulins clearly addresses limitations characteristic of the current set of premix insulin options, potentially enabling greater use in people with type 2 diabetes.”

In a new study, investigators examined the effects of the BioChaperone Combo on post-meal blood glucose levels in patients with type 2 diabetes compared with patients treated with different therapies.

Patients with diabetes who require treatment with basal insulin treatment typically receive twice-daily premixed insulins or multiple daily injections, which consist of up to 3 mealtime injections of prandial insulin plus their basal insulin, according to the study.

The BioChaperone Combo was created to develop a simple alternative to the treatment options for patients with type 2 diabetes.

Included in the study were 39 patients with type 2 diabetes who were randomized to receive the BioChaperone Combo, a premix formulation of biphasic insulin lispro (Humalog Mix25), or separate injections of long-acting insulin analog glargine and fast-acting insulin analog lispro.

The primary objective of the study was to compare the post-meal glycemic control on days 2 or 3 when the drugs were administered immediately before a meal.

The investigators found that the BioChaperone Combo resulted in a glucose excursion reduction of 18% within 2 hours of administration compared with biphasic insulin lispro, according to the study.

At 1 hour, blood glucose levels were significantly reduced among patients who received BioChaperone Combo compared with biphasic insulin lispro.

The authors also noted that the BioChaperone Combo was linked to a significantly decreased rate of hypoglycemic events and achieved an in-target range during meal tests compared with the other treatment, according to the study.

Compared with simultaneous injections of insulin analog glargine and fast-acting insulin analog lispro, the BioChaperone Combo reduced blood glucose excursion within the first 2 hours and blood glucose concentrations at 1 hour, according to the study.

The investigators found no significant difference in hypoglycemic events for the participants.

Overall, the therapies were well tolerated, with only 2 serious adverse events leading to treatment discontinuation. There were no new safety events discovered, according to the study.

“We are extremely pleased with these results, which strengthen the body of evidence supporting that BioChaperone Combo could be as simple as a premix, but with better glycemic control and a lower risk of hypoglycemia. To our knowledge, it is unprecedented for an insulins combination product to show a level of control and safety similar to the separate injections of basal and prandial insulins in people with type 2 diabetes.” said Olivier Soula, deputy general manager, director of R&D of Adocia. “This opens a new treatment dimension for people with type 2 diabetes, offering them a truly efficient, safe and easy-to-use 2-in-1 insulin combination. The next step will be to document dose-response, which is a regulatory requirement to prepare for Phase 3.”