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LXN Corporation's Fructosamine Test to Assist In Bristol-Myers Squibb Drug Trials.

Test for Assessing Overall Diabetes Control Included in Studies

Of Treatment Regimens for Patients with Type 2 Diabetes

SAN DIEGO, Oct. 13 /PRNewswire/ --

LXN Corporation today announced the inclusion of its IN CHARGE(TM) Diabetes Control System into two clinical trials sponsored by Bristol-Myers Squibb. The IN CHARGE dual-test system, which combines a rapid glucose test with a home test for glycated protein (fructosamine) on a single hand-held meter, will be used by Bristol-Myers Squibb in a clinical study designed to compare two different treatment regimens for patients with Type 2 diabetes as well as a clinical trial designed to assess the potential for first line therapy of Bristol-Myers Squibb's recently FDA-cleared drug combination of metformin/glyburide.

The IN CHARGE System will be used to help determine effective drug dosage levels in the two clinical trials, which are titled: CV138-061 "A Multicenter, Randomized, Double-Blind Clinical Trial Comparing The Safety and Efficacy of Metformin/Glyburide Tablets To Concurrent Rosiglitazone and Metformin Therapy In Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Metformin Monotherapy," and CV138-058 "A Multicenter, Randomized, Double-blind, Active Control Trial To Evaluate The Safety And Efficacy Of A New Formulation Of Glyburide/Metformin HCl Tablets (1.25/500) As First Line Therapy In Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Diet And Exercise."

Controlling average blood sugar levels is a primary goal of different therapies used in diabetes management. The In Charge fructosamine home test, introduced by LXN as the GlucoProtein(R) test, indicates the average of continuous glucose changes over the prior two- to three-week time period. In contrast, traditional glucose tests provide a snapshot of glycemic control at any one given moment in time. GlucoProtein testing can therefore help allow the patient to determine whether or not their therapy is working in the convenience of their home.

"We expect this clinical trial experience will help to demonstrate the value of GlucoProtein testing as a clinical decision tool for physicians managing patients with diabetes. It has always been somewhat of a dilemma to assess antihyperglycemic drug efficacy solely using HbA1c testing and traditional glucose tests," said David Kelemen, vice president, marketing, for LXN. "While HbA1c testing is still the primary clinical endpoint, having to wait several months to assess overall efficacy of a drug is like putting patients on a diet and not allowing them to weigh themselves on a scale for 12 weeks. The physician has few interim ways of comprehensively assessing drug efficacy, and patients can become frustrated because they have little immediate feedback to act as a behavioral reinforcement."

"We believe GlucoProtein testing, along with glucose testing, provides physicians and patients with a new tool to help obtain better and more timely information that can be used to improve the utilization of currently available diabetes drugs," Kelemen added.

Based in San Diego, Calif., LXN Corporation develops and markets innovative products and services for diabetes management. Founded in January 1994, the privately held company is committed to helping people with diabetes live longer, healthier lives through improved glucose control. LXN markets the IN CHARGE(TM) Diabetes Control System for patient self-testing and the Duet(R) Diabetes Control System, developed for in-office testing of patients' overall glucose control. Further information is available at LXN's website:
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Publication:PR Newswire
Date:Oct 13, 2000
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