1-2-3 Study Demonstrates Efficacy of NovoLog(R) Mix 70/30 in Reaching American Diabetes Association A1C Targets With Once-Daily Dosing and the Additional Benefit of Intensifying Therapy

SAN DIEGO, Calif., June 13 /PRNewswire/ — NovoLog(R) Mix 70/30 (70% insulin aspart protamine suspension and 30 percent insulin aspart injection, [rDNA origin]) enables 77 percent of type 2 diabetes patients to achieve glycemic targets when titrated as the disease progresses, according to the 1-2-3 Study. The findings show that NovoLog Mix 70/30 can be used effectively once and up to three times daily among patients who were unsuccessfully treated with oral antidiabetic agents (OADs) with or without basal insulin therapy.

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Data from the 1-2-3 Study (278-OR),(1) presented yesterday at the 65th annual Scientific Sessions of the American Diabetes Association (ADA), show that 41 percent of the patients enrolled in the trial achieved an A1C target of < 7 percent and 21 percent achieved an A1C level less than or equal to 6.5 percent when receiving just a single daily dose of NovoLog(R) Mix 70/30.

“These results are particularly encouraging for patients who are inadequately treated with OADs,” said Dr. Garber. “Now physicians can feel comfortable in prescribing a once-daily dose of NovoLog(R) Mix 70/30 to control diabetes. For those patients not controlled with a single dose, our study clearly demonstrates how a physician can then easily transition patients to two doses and occasionally, as necessary, three doses a day of the same insulin to achieve target A1C goals. “

1-2-3 Study key findings

In a 48-week, multi-center, open-label trial, patients with type 2 diabetes who were not achieving targets on OADs (with or without once-daily basal insulin therapy with NPH or glargine) were titrated with NovoLog(R) Mix 70/30 to target plasma glucose levels. At the end of the trial, the study showed 77 percent of patients achieved A1C levels of < 7.0 percent and 60 percent of patients attained an A1C level of less than or equal to 6.5 percent through once, twice or three-times daily dosing of NovoLog(R) Mix 70/30.

                      A1C less than or equal to 6.5%                 A1C < 7%                                    (AACE, IDF Goal)               (ADA Goal)    Phase I:                                    21 %                     41 %   Once-daily dosing   Phase II:                                   52 %                     70 %   Twice-daily dosing   Phase III:                                  60 %                     77 %   Three times daily dosing   Total Study Results                         60 %                     77 %   Baseline A1C was 8.6%   

“This study clearly demonstrates the convenience and efficacy of using a dual-acting insulin analog, enabling physicians to tailor treatment to meet the needs of their type 2 patients in a safe and effective manner,” said lead investigator Alan Garber, M.D., Ph.D., Professor of Medicine Biochemistry and Cell Biology at Baylor College of Medicine. “Further, the results indicate that clinicians can transition patients to insulin therapy often with a single, daily dose and then titrate treatment as a patient’s diabetes progresses without having to alter therapy. As a result, physicians now can have an effective treatment regimen, particularly as diabetes progresses.”

1-2-3 Study trial design

The 1-2-3 Study was designed to assess the percentage of patients with type 2 diabetes achieving A1C levels less than or equal to 6.5 percent by titrating NovoLog(R) Mix 70/30 to target SMBG levels.

The study included 100 patients and was conducted in three separate phases. In Phase 1, patients initiated treatment with NovoLog(R) Mix 70/30 once before supper. Dosing frequency was increased to twice-daily in Phase 2 and to three-times daily in Phase 3 at 16 and 32 weeks, respectively, based upon A1C levels.

Patients completed end-of-study when they achieved A1C less than or equal to 6.5 percent or 48 weeks, whichever came first. Analysis to determine the number of patients attaining A1C less than or equal to 6.5 percent was done at 16, 32 and 48 weeks.

About NovoLog(R) Mix 70/30

NovoLog(R) Mix 70/30 is indicated for the treatment of patients with diabetes mellitus for the control of hyperglycemia. Because NovoLog(R) Mix 70/30 has peak pharmacodynamic activity one hour after injection; it should be administered with meals. NovoLog(R) Mix 70/30 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog(R) Mix 70/30 or one of its excipients. Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog(R) Mix 70/30.

Any change in insulin should be made cautiously and only under medical supervision.

Full prescribing information for NovoLog(R) Mix 70/30 is available by contacting Novo Nordisk Inc. or visiting http://www.novonordisk-us.com/ .

About Novo Nordisk

Novo Nordisk is a healthcare company with an 80-year history of innovation and achievement in diabetes care. With the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems, Novo Nordisk is a world leader in diabetes care. In the United States, Novo Nordisk’s ambition is to change the course of diabetes for good. Working as a catalyst to improve diabetes prevention and treatment, the company strives to be the preferred partner for employees, patients, healthcare providers, and others in the healthcare system who share its vision to defeat diabetes. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk’s business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 21,000 full-time employees in 78 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For global information, visit http://www.novonordisk.com/ ; for United States information, visit http://www.novonordisk-us.com/ .

   NovoLog is a registered trademark of Novo Nordisk A/S.     (1) Jain et al (final data from phase I-III): Efficacy of Biphasic        Insulin Aspart 70/30 in Patients with T2DM Not Achieving Glycemic        Targets on OADs With/Without Basal Insulin Therapy. Oral Presentation        278-OR, presented at: 65th annual meeting of the American Diabetes        Association, June 12, 2005, San Diego, CA, USA.  

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Novo Nordisk

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Web site: http://www.novonordisk-us.com/http://www.novonordisk.com/