ONGLYZA used with insulin maintains improvement in glucose control in adults with type 2 diabetes

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced results from an investigational Phase 3b clinical study in which the addition of ONGLYZA^™ (saxagliptin) 5 mg to ongoing insulin therapy (with or without metformin) maintained reductions of 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 47^th 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 71^st American Diabetes Association (ADA) Scientific Sessions in San Diego, CA in June 2011.

“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”

In the 52-week analysis, change from baseline in HbA1c in patients taking ONGLYZA 5 mg added to insulin (with or without metformin) was -0.75% compared to -0.38% for those taking placebo added to insulin (with or without metformin). 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 (with or without metformin). 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.

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."

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.