SOURCE: Novo Nordisk

October 17, 2008 08:00 ET

New Data From Head-to-Head Phase 3 Trial Demonstrate That Liraglutide Is More Effective Than Exenatide in Treatment of Type 2 Diabetes

MONTREAL--(Marketwire - October 17, 2008) - Today, at the Canadian Diabetes Association Congress, physicians will get a first-time look at more detailed results from a phase 3b clinical study (LEAD™ 6) released by Novo Nordisk (NYSE: NVO) comparing the investigational new drug liraglutide to exenatide. The study showed that liraglutide, a human GLP-1 analog, administered once daily was significantly more effective at improving blood glucose control (as measured by HbA1c) than exenatide, a GLP-1 mimetic, administered twice daily.

"In this study, reduction in blood glucose was greater with liraglutide than with exenatide," said Lawrence Blonde, MD, Director of the Ochsner Diabetes Clinical Research Unit in the Department of Endocrinology, Diabetes, and Metabolism at the Oxford Center in New Orleans. "Patients treated with once-daily liraglutide achieved better blood glucose control and also had less minor hypoglycemia than those treated with exenatide."

Fasting plasma glucose was also reduced significantly more with liraglutide compared to exenatide. Furthermore, liraglutide was also associated with higher HOMA-B values, an assessment of beta-cell function.

The 26-week study included 464 people with type 2 diabetes who were randomized to treatment with either liraglutide 1.8 mg once daily or exenatide 10 µg twice daily, both as an add-on to their existing treatment consisting of metformin and/or a sulphonylurea.

The overall rate of hypoglycemia in the study was low. Liraglutide patients experienced significantly less minor hypoglycemia compared to those on exenatide.

Nausea was the most common side effect for both treatments and was reported at a level of 25.5% in the liraglutide group and 28% in exenatide group (percent of all study participants reporting nausea at least once). However, in the liraglutide group, the percentage of patients reporting nausea in each week fell to 8% after 5 weeks, 4% after 10 weeks and 3% after 26 weeks. In the exenatide group, reports of nausea fell to 13% after 8-10 weeks of treatment and remained above 10% for more than 20 weeks.

Other common gastrointestinal-related adverse events with liraglutide were diarrhea, vomiting and dyspepsia.

Patients on both treatments lost weight during the study. Weight reduction in patients on liraglutide was also consistently seen in the LEAD™ 3a studies.

Key LEAD™ 6 Data:

                                              Liraglutide    Exenatide 10
                                              1.8 mg QD +     µg, BID +
                                              metformin       metformin
                                                and/or          and/or
                                                  SU              SU
                                                N=233           N=231
                                            --------------  --------------
Diabetes duration, years at baseline        8.5             7.9
                                            --------------  --------------
BMI, kg/m2 at baseline                      32.9            32.9
                                            --------------  --------------
HbA1c, % at baseline                        8.2             8.1
                                            --------------  --------------
Change in HbA1c % (SE) from baseline        -1.12* (0.08)   -0.79 (0.08)
                                            --------------  --------------
% HbA1c < 7.0%                              54*             43
                                            --------------  --------------
% HbA1c less or equal to 6.5%               35*             21
                                            --------------  --------------
Weight change, kg from baseline             -3.24           -2.87
                                            --------------  --------------
% Change in HOMA-B  from baseline           32.1*           2.7
                                            --------------  --------------
Change FPG (fasting plasma glucose) mmol/L
 from baseline                              -1.61*          -0.60
                                            --------------  --------------
Minor hypoglycemic events/subject/year      1.9*            2.6
                                            --------------  --------------
*P < 0.05

About Liraglutide

Once-daily liraglutide is the first human glucagon-like peptide-1 (GLP-1) analog developed for the treatment of type 2 diabetes. Liraglutide works by stimulating the release of insulin and inhibiting the release of glucagon from the liver after meals only if blood glucose levels are elevated. Weight loss with liraglutide is attributed to the fact that it slows gastric emptying and leads to increased satiety after meals. Liraglutide is naturally broken down in the body and does not require renal excretion.

On May 23, 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration in the United States, as well as a marketing authorization application to the European Medicines Agency in Europe, for the approval of liraglutide for the treatment of people with type 2 diabetes. A New Drug Application was also submitted for approval in Japan on July 14, 2008.

About LEAD™ (Liraglutide Effect and Action in Diabetes)

LEAD™ (Liraglutide Effect and Action in Diabetes) 6 is the first trial to be reported from the phase 3b LEAD™ program. Topline results from the LEAD™ 6 study were released by Novo Nordisk in a Stock Exchange Announcement on June 6, 2008.

The phase 3a LEAD™ program, which comprised the regulatory filing documentation for liraglutide, included trials 1-5. The purpose of the LEAD™ program is to compare liraglutide directly against commonly used therapies in type 2 diabetes, except for metformin, with which it is used in combination.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy and hormone replacement therapy. 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 26,550 employees in 80 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 more information, visit novonordisk.com.