Pharmaceutical companies Bristol-Myers Squibb and AstraZeneca have announced results from an investigational phase 3b clinical study of use of Onglyza (saxagliptin) in diabetic patients.

The study was based on the addition of Onglyza (saxagliptin) 5mg to ongoing insulin therapy (with or without metformin) to maintain reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in adult patients with type 2 diabetes compared to the addition of placebo (with or without metformin) from 24 to 52 weeks.

These results, presented at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal, are from an extension of a 24-week trial, the results of which were presented at the 71st American Diabetes Association (ADA) Scientific Sessions in San Diego, CA in June 2011.

In the 52-week analysis, change from baseline in HbA1c in patients taking Onglyza 5 mg added to insulin was -0.75% compared to -0.38% for those taking placebo added to insulin, a statement from the company said.

There was also a greater increase from baseline mean daily insulin dose in patients who received placebo compared to patients who received Onglyza 5 mg.

It is unknown whether increased insulin doses by patients in the placebo group could have affected the magnitude of differences seen between the two treatment groups in the efficacy analyses, it said.

The proportion of patients in each treatment group who experienced at least one adverse event over the 52-week treatment period was similar. The most common events included hypoglycemia, urinary tract infection, nasopharyngitis, upper respiratory tract infection, headache and bronchitis.

“Since many patients with type 2 diabetes will eventually require insulin, it is important to assess a compound’s ability to be used in combination with insulin to manage blood glucose control over the long term,” said Anthony Barnett, MD, University of Birmingham and Heart of England NHS Foundation Trust and principal investigator of the study.

“This is the first longer-term study to report that Onglyza 5 mg, used with insulin, maintains improvement in glucose control over 24 to 52 weeks in adult patients with type 2 diabetes”, he said.

In Europe, Onglyza is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycemic control - in combination with metformin.

When metformin alone, with diet and exercise, does not provide adequate glycemic control; in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycemic control in patients for whom use of metformin is considered inappropriate; or in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycemic control in patients for whom use of a thiazolidinedione is considered appropriate.

Onglyza is currently not indicated in combination with insulin therapy, the statement said.

In the United States, Onglyza is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults with type 2 diabetes mellitus in multiple clinical settings.

Onglyza should not be used for the treatment of patients with type 1 diabetes mellitus or diabetic ketoacidosis (increased levels of ketones in the blood or urine), as it would not be effective in these settings. – TradeArabia News Service