Clinical trial into new insulin has been completed

A Phase II clinical trial exploring the use of a new insulin therapy for the treatment of type one diabetes has reached its end after all scheduled follow-up visits with patients were been completed. The trial for BIOD -123 - an ultra-rapid-acting injectable mealtime insulin therapy - has been conducted by 33 institutions in the US and has involved 132 type one diabetes patients.

BIOD-123 has been designed as a fast-acting mealtime insulin, which works more rapidly in comparison to the current insulin analogs that are used for the treatment of type one and type two diabetes. Earlier clinical trials on the drug have shown that is absorbed much quicker after subcutaneous administration than traditional mealtime insulins. The previous clinical trials found that when BIOD-123 is administered prior to a meal, it results in a similar mealtime insulin release as occurs within people that do not suffer from diabetes. So far 20 clinical trials have been performed on BIOD-123, which have included over 1,000 diabetic patients.  

The randomised, open label Phase II trial involved patients receiving either the new BIOD-123 insulin or Humalog at mealtimes for a period of 18 weeks. The base insulin for both parts of the trial used the basal insulin, insulin glargine - sold under the name Lantus. The trial measured the primary endpoint glycated haemoglobin (HbA1c) control in patients. This is when glucose joins with haemoglobin within the blood. The levels of HbA1c are determined by the glucose levels in the blood. Secondary endpoints were also measured throughout the trial, these included weight changes, glycemic variability, postprandial glucose excursions and hypoglycemic event rates.

Doctor Errol De Souza, president and chief executive officer of Biodel, said: "Completing the BIOD-123 Phase 2 clinical trial is another significant milestone in the development of novel ultra-rapid-acting mealtime insulins to aid patients and healthcare professionals in the treatment of diabetes. We look forward to sharing the top-line results by the end of this quarter."