2009-10-05

Study Finds That ONGLYZA(TM) (saxagliptin) When Added to Metformin was Non-Inferior to JANUVIA (sitagliptin) When Added to Metformin in Reducing Hemoglobin (HbA1c) in Adults With Type 2 Diabetes Mellitus


Princeton, New Jersey and London (ots/PRNewswire) -Results from an 18-week phase 3b study in adults with type 2 diabeteswith inadequate glycemic control on metformin therapy alone foundthat the addition of treatment with ONGLYZA(TM) (saxagliptin) 5 mgper day achieved the primary objective of demonstratingnon-inferiority compared to the addition of treatment with JANUVIA(R)(sitagliptin) 100 mg per day in reducing HbA1c from baseline. In thisstudy, overall adverse events were reported at a similar rate forindividuals taking ONGLYZA 5 mg plus metformin and JANUVIA 100 mgplus metformin. This study was submitted to the European MedicinesAgency (EMEA) as part of the Marketing Authorization Application forONGLYZA. Complete findings from this study will be submitted forpublication in the first half of 2010.

ONGLYZA, a dipeptidyl peptidase 4 (DPP4) inhibitor, was recentlyapproved by the European Commission as an adjunct to diet andexercise to improve blood sugar (glycemic) control in adults for thetreatment of type 2 diabetes mellitus. ONGLYZA once daily can be usedin combination with commonly prescribed oral anti-diabeticmedications - metformin, sulfonylureas or thiazolidinediones (TZD) tosignificantly reduce HbA1c levels. ONGLYZA has also been approved bythe U.S. Food and Drug Administration (July, 2009) as an adjunct todiet and exercise to improve blood sugar (glycemic) control in adultsfor the treatment of type 2 diabetes mellitus. ONGLYZA should not beused for the treatment of type 1 diabetes or for the treatment ofdiabetic ketoacidosis (high levels of certain acids, known asketones, in the blood or urine). ONGLYZA has not been studied incombination with insulin.

"We are pleased with the findings from this study, which supportthat the addition of ONGLYZA to metformin lowers HbA1c in adults withinadequate glycemic control despite treatment with metformin," saidAndre Scheen, MD, Head of the Division of Diabetes, Nutrition andMetabolic Disorders and Clinical Pharmacology Unit, AcademicHospital, Liège, Belgium.

About the Study

This study was an 18-week international, multicenter, randomized,parallel-group, double-blind, active-controlled phase 3b study of 801adults with type 2 diabetes (ages 22-87) whose HbA1c was greater than6.5 percent and less than or equal to 10 percent at baseline. Thestudy was designed to evaluate the efficacy and safety of ONGLYZA(saxagliptin) 5 mg and JANUVIA 100 mg in addition to metformin inadults with type 2 diabetes who did not attain adequate glycemiccontrol on metformin therapy alone. Individuals were randomized toone of two separate treatment arms, ONGLYZA 5 mg once daily plusopen-label metformin (n=403, baseline HbA1c = 7.68) or JANUVIA 100 mgonce daily plus open-label metformin (n=398, baseline HbA1c = 7.69).The primary endpoint of the study was to assess if the change frombaseline in HbA1c achieved with ONGLYZA 5 mg per day was non-inferior(defined in the study protocol as a treatment group numericaldifference in the HbA1c reduction of less than 0.3 for the upperlimit of the confidence interval [CI]) to JANUVIA 100 mg per day whenboth were added to a stable dose of metformin, 1500 mg or higher.

Study Results

In the primary analysis of individuals who completed the studyand complied with study procedures, ONGLYZA 5 mg per day achieved anadjusted mean change from baseline in HbA1c of -0.52 percent,compared to -0.62 percent for subjects taking JANUVIA 100 mg per day.Results of the study demonstrated that therapy with ONGLYZA 5 mg wasnon-inferior to JANUVIA 100 mg when added to metformin (difference inadjusted mean change from baseline vs. Januvia plus metformin 0.09percent, 95 percent CI -0.01 to 0.20). Non-inferiority of ONGLYZA toJANUVIA was also demonstrated in a confirmatory analysis of allindividuals receiving study treatment for whom a change from baselinein HbA1c could be calculated.

In the study, ONGLYZA 5 mg added to metformin demonstrated asafety profile similar to JANUVIA 100 mg added to metformin. Thenumber of individuals experiencing adverse events or serious adverseevents after 18 weeks was similar between the two treatment groups:(adverse events: 47.1 percent for ONGLYZA 5 mg plus metformin, 47.2percent for JANUVIA 100 mg plus metformin; serious adverse events:1.7 percent for ONGLYZA 5 mg plus metformin, 1.3 percent for JANUVIA100 mg plus metformin). A total of 9 patients discontinued in eachtreatment arm due to an adverse event. Two patients (0.5 percent) inthe ONGLYZA plus metformin arm discontinued treatment due to aserious adverse event. The number of individuals with anyhypoglycemic event was similar between the two treatment groups (3.2percent for ONGLYZA (saxagliptin) 5 mg plus metformin, 2.8 percentfor JANUVIA plus metformin). The most common adverse events (greaterthan 5 percent in at least one study group) reported with ONGLYZA 5mg plus metformin vs. JANUVIA plus metformin were influenza (5.7percent vs. 5.8 percent, respectively) and urinary tract infection(5.7 percent vs. 5.3 percent, respectively).

To conclude, the study achieved its primary endpoint -demonstrating that treatment with ONGLYZA 5 mg plus metformin wasnon-inferior compared to treatment with JANUVIA 100 mg plus metforminas measured by a change from baseline in HbA1c. Treatment withONGLYZA 5 mg plus metformin had a safety profile similar to JANUVIA100 mg plus metformin.

Background On Previously Presented Studies of ONGLYZA When UsedIn Combination With Metformin

ONGLYZA was studied extensively with metformin, the mostcommonly-prescribed oral anti-diabetic medication. Two previouslyreported studies demonstrated that ONGLYZA, when used in combinationwith metformin, effectively lowered HbA1c, fasting plasma glucose andpostprandial glucose, three key measures of glycemic control. Inadult patients inadequately controlled on metformin, the addition ofONGLYZA 2.5 mg (n=192, baseline A1C 8.1 percent) and 5 mg (n=191,baseline A1C 8.1 percent) once daily reduced A1C levels from baselineto Week 24 by -0.6 percent and -0.7 percent respectively for ONGLYZAvs. +0.1 percent increase for placebo (p-values less than 0.0001 vs.placebo, n=179, baseline A1C 8.1 percent). The reported incidence ofhypoglycemia in ONGLYZA 2.5 mg and 5 mg compared with placebo was 7.8percent, 5.8 percent and 5 percent, respectively.

For those new to diabetes medications, the use of ONGLYZA 5 mgwith metformin (n=320, baseline A1C 9.4 percent) as initial therapylowered A1C from baseline to week 24 by -2.5 percent vs. -2 percentfor metformin plus placebo (p-values less than 0.0001, n=313,baseline A1C 9.4 percent). Significantly more adult patients in theONGLYZA plus metformin arm achieved the American Diabetes Associationrecommended A1C level of less than 7 percent than those treated withmetformin plus placebo (60 percent vs. 41 percent, respectively,p-values less than 0.05). The reported incidence of hypoglycemia was3.4 percent in adult patients given ONGLYZA (saxagliptin) 5 mg plusmetformin and 4 percent in adult patients given metformin alone. Theadverse reactions occurring in greater than or equal to 5 percent ofadult patients and more commonly than in adult patients treated withmetformin alone were headache (7.5 percent vs. 5.2 percent) andnasopharyngitis (6.9 percent vs. 4 percent).

Bristol-Myers Squibb and AstraZeneca Collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaborationin January 2007 to develop and commercialize select investigationaldrugs for type 2 diabetes. These therapies address two key pathwaysin managing type 2 diabetes and seek to expand the range of currentand future therapeutic options. Our collaboration is dedicated toglobal patient care, improving patient outcomes and creating a newvision for the treatment of patients living with type 2 diabetes.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical companycommitted to discovering, developing and delivering innovativemedicines that help patients prevail over serious diseases.

About AstraZeneca

AstraZeneca is a major international healthcare business engagedin the research, development, manufacturing and marketing ofmeaningful prescription medicines and supplier for healthcareservices. AstraZeneca is one of the world's leading pharmaceuticalcompanies with healthcare sales of US$ 31.6 billion and is a leaderin gastrointestinal, cardiovascular, neuroscience, respiratory,oncology and infectious disease medicines.

ONGLYZA is a trademark of the Bristol-Myers Squibb Company.

JANUVIA is a trademark of Merck & Co. Inc.

Summary of Product Characteristics

ONGLYZA

See full prescribing information(http://www.makealias.com/just/SmPC.pdf )

ots Originaltext: Bristol-Myers Squibb Company and AstraZenecaIm Internet recherchierbar: http://www.presseportal.de

Contact:CONTACTS: Media: Carmel Hogan, Bristol-Myers Squibb, +33-674-107-658,Carmel.hogan@bms.com; Ken Dominski, Bristol-Myers Squibb,+1-609-252-5251, Ken.dominski@bms.com; Neil McCrae, AstraZeneca, +44-207-304-5045, Neil.mccrae@astrazeneca.com; Christopher Sampson, AstraZeneca, +44-207-304-5130, Christopher.sampson@astrazeneca.com; Jim Minnick, AstraZeneca, +1-302-885-5135, jim.minnick@astrazeneca.com. Investors: John Elicker, Bristol-Myers Squibb, +1-609-252-4611, john.elicker@bms.com;Karl J. Hard, AstraZeneca, +44-207-304-5322, Karl.J.Hard@astrazeneca.com; Jonathan Hunt, AstraZeneca, +44-7775-704032, Jonathan.Hunt@astrazeneca.com; Edward Seage, AstraZeneca, +1-302-886-4065, Edward.Seage@astrazeneca.com; Jorgen Winroth, AstraZeneca, +1-212-579-0506, Jorgen.Winroth@astrazeneca.com

Bristol-Myers Squibb Company and AstraZeneca

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Study Finds That ONGLYZA(TM) (saxagliptin) When Added to Metformin was Non-Inferior to JANUVIA (sitagliptin) When Added to Metformin in Reducing Hemoglobin (HbA1c) in Adults With Type 2 Diabetes Mellitus

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