Bristol-Myers
Squibb Company (NYSE: BMY) and AstraZeneca
(NYSE: AZN) today announced the commencement of the “Saxagliptin
Assessment of Vascular
Outcomes Recorded
in Patients with Diabetes Mellitus” trial (SAVOR-TIMI 53), a
multicenter, randomized, double-blind, placebo-controlled Phase 4 study,
to evaluate treatment with ONGLYZA™
(saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, in adult type
2 diabetes patients with cardiovascular risk factors. The five-year
study will follow approximately 12,000 patients with type 2 diabetes,
who have either a history of previous cardiovascular events or multiple
risk factors for vascular disease, and includes patients with renal
impairment.
“One of the objectives of the SAVOR-TIMI 53 study is to test superiority
of treatment with ONGLYZA versus placebo when added to current therapy,
as well as exclude unacceptable cardiovascular risk”
The objectives of the SAVOR-TIMI 53 trial are to test the hypothesis of
whether treatment with ONGLYZA compared with placebo when added to a
patients’ current standard of care will result in a reduction in the
composite endpoint of cardiovascular death, non-fatal myocardial
infarction or non-fatal ischaemic stroke and to exclude an unacceptable
cardiovascular toxicity. The SAVOR-TIMI 53 trial was in part designed to
fulfill a post-marketing requirement for the U.S. Food and Drug
Administration (FDA), as well as to help answer the important question
of potential benefit beyond glucose lowering. There have been no
clinical studies establishing conclusive evidence of macrovascular risk
reduction with ONGLYZA or any other antidiabetic drug.
Eugene Braunwald, M.D., Chairman, and Deepak L. Bhatt M.D., MPH, Senior
Investigator of the TIMI Study Group, in conjunction with Itamar Raz,
M.D., Head of the Diabetes Unit at the Hadassah University Medical
Center, Jerusalem, will serve as principal investigators and conduct the
trial for Bristol-Myers Squibb and AstraZeneca.
"One of the objectives of the SAVOR-TIMI 53 study is to test superiority
of treatment with ONGLYZA versus placebo when added to current therapy,
as well as exclude unacceptable cardiovascular risk," said Eugene
Braunwald, M.D., Chairman of the TIMI Study Group.
ONGLYZA has been submitted for regulatory review in more than 50
countries and is approved in 38 countries, including the United States
and European Union. ONGLYZA was approved by the U.S. FDA in July 2009.
ONGLYZA (saxagliptin) is indicated as an adjunct to diet and exercise to
improve blood sugar (glycemic) control in adults for the treatment of
type 2 diabetes mellitus. ONGLYZA once daily can be used in combination
with commonly prescribed oral anti-diabetic medications – metformin,
sulfonylureas or thiazolidinediones (TZD) – or as a monotherapy to
significantly reduce glycosylated hemoglobin (A1C) levels. ONGLYZA
should not be used for the treatment of type 1 diabetes or for the
treatment of diabetic ketoacidosis (high levels of certain acids, known
as ketones, in the blood or urine). ONGLYZA has not been studied in
combination with insulin.
Spermidine regulates RIPK1 to combat diabetes and vascular damage