Navigation Links
Two-Year Data Show Investigational Drug Liraglutide More Effective at Lowering Blood Sugar Than Glimepiride: Oral 162
Date:6/7/2009

NEW ORLEANS, June 7 /PRNewswire-FirstCall/ -- Novo Nordisk (NVO) data presented today at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) showed that once-daily liraglutide, taken as monotherapy, leads to statistically significant and sustained reductions in blood sugar and weight after two years of treatment.

In the study, 58% of patients treated with liraglutide 1.8 mg once daily reached and maintained the ADA's blood sugar target of A1C less than 7% versus 37% of patients treated with glimepiride 8 mg once daily.

"The fact that liraglutide continues to effectively lower blood sugar after two years of treatment is consistent with its other long-term clinical benefits such as continued reductions in fasting blood sugar and weight," said Dr. Alan Garber, Baylor College of Medicine, Houston, a LEAD(TM) 3 principal study investigator. "Even with available treatments, many type 2 diabetes patients still struggle to control their blood sugar, while losing weight. Liraglutide represents an important advance for these patients."

The LEAD(TM) 3 extension study also documented that treatment with liraglutide leads to early and lasting weight loss. Many currently available diabetes treatments lead to weight gain, a concern for type 2 diabetes patients, most of whom are already overweight. After two years of treatment with 1.8 mg of liraglutide, mean body weight decreased significantly (-2.7 kg) compared to overall weight increase in the glimepiride group (+1.1 kg).

Hypoglycemia is a condition where blood sugar levels become too low. Minor hypoglycemia was more than six times less frequent in the liraglutide treatment groups compared with the glimepiride group.

About LEAD(TM) 3 Extension

The LEAD(TM) 3 Extension compared the efficacy and safety of liraglutide (1.8 mg and 1.2 mg, once daily) to glimepiride (8 mg, once daily) in patients with type 2 diabetes. Patients were treated previously with diet/exercise or low doses of one oral antidiabetic drug (OAD). The trial had a 52-week randomized, double-blind period followed by the one-year extension; 59% entered the extension period of the trial and 43% of these patients completed the full two-year study period.

LEAD(TM) 3: two-year data

    Two years                Liraglutide       Liraglutide       Glimepiride
     monotherapy             1.8 mg, QD        1.2 mg, QD        8 mg, QD
                             N=154             N=149             N=137

    Diabetes duration,
     years at baseline         5.0                5.0              5.0

    Previous treatment:
    % diet/exercise             35%                38%              34%
    % OAD monotherapy           65%                62%              66%

    A1C % at baseline          8.1                8.1              8.0

    BMI, kg/m(2) at
     baseline                   33                 33               33

    Change in A1C% from
     baseline                 -1.1               -0.9             -0.6

    Change in A1C%  from
     baseline (in
     patients with <3
     years duration of
     diabetes)                -1.4               -1.1             -0.7

    % A1C <7.0%                 58                 53               37

    Change FPG (Fasting
     Plasma Glucose)
     mg/dL from baseline       -27                -24               -6

    Weight change, kg
     from baseline            -2.7               -2.1              1.1

    Minor hypoglycemic
     events/patient/year      0.23               0.21             1.76

Safety and tolerability of liraglutide

The rate of minor hypoglycemia was statistically significantly lower with both liraglutide dose groups compared to the glimepiride-treated group. The most common gastrointestinal-related adverse events were nausea, diarrhea and vomiting, and most were transient. Other adverse events reported included flu-like symptoms.

About LEAD(TM) (Liraglutide Effect and Action in Diabetes)

The LEAD(TM) program comprises five randomized, controlled, double-blinded studies plus one open-label head-to-head study against exenatide and involved more than 4,000 patients with type 2 diabetes in 40 countries.

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 only when blood sugar levels are high. 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 (FDA) in the U.S., as well as a marketing authorization application to the European Medicines Agency (EMEA), 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.

On April 23, 2009, Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the EMEA adopted a positive opinion, recommending marketing authorization of liraglutide for treatment of type 2 diabetes in Europe.

In the U.S., a regulatory decision is pending.

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 27,900 employees in 81 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.


'/>"/>
SOURCE Novo Nordisk
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Two-Year Data Reinforce Effect of ACTEMRA(R) (tocilizumab) in Inhibiting Progression of Joint Damage and Improving Physical Function in Rheumatoid Arthritis Patients
2. Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients With Multiple Sclerosis
3. The Lancet Publishes Two-Year Results of Abbotts Fully Bioabsorbable Drug Eluting Stent
4. Circulation Publishes Pivotal Two-Year Results On XIENCE V(TM) Drug Eluting Stent
5. Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System
6. XTENT Announces Positive Two-Year CUSTOM I and One-Year CUSTOM II Trial Data for Novel Drug-Eluting Stent System
7. Two-Year Outcomes From Large Head-to-Head Clinical Trial Indicate Similar Safety Profile in Diabetic Patients for Cypher(R) Sirolimus-Eluting Coronary Stent and Taxus Stent
8. Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes
9. Investigational Cancer Drug BSI-201 Showed Clinical Benefit in 62% of Patients with Triple-Negative Metastatic Breast Cancer and Significantly Prolonged Survival
10. Intercell AG Announces First Subject Enrolled in a Phase II Trial for the Further Development of Its Investigational Vaccine Enhancement Patch to Improve Pandemic Influenza Prevention in Collaboration With U.S. Department of Health and Human Services (HHS
11. Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-CXCR4 Antibody, MDX-1338
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
(Date:6/23/2016)... RIDGE, Ill. and INDIANAPOLIS ... of students receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship ... The 2016 scholarship winners, announced today online at ... to let type 1 diabetes stand in the way ... Diabetes has supported the Foundation,s scholarship program since 2012, ...
(Date:6/23/2016)... , June 23, 2016 The vast majority ... outpatient dialysis facility.  Treatments are usually 3 times a ... per visit, including travel time, equipment preparation and wait ... but especially grueling for patients who are elderly and ... skilled nursing and rehabilitation centers for some duration of ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort to ... treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain management ... (SCD) is a disorder of the red blood cells, which can cause episodes of ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Dr. Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile ... orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can ...
(Date:6/24/2016)... ... ... BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a ... an hour by 2020 and then adjusting it yearly to increase at the same rate ... assure the wage floor does not erode again, and make future increases more predictable. , ...
(Date:6/24/2016)... ... 24, 2016 , ... EB Medicine presented its first-ever “Issue ... conference in Ponte Vedra Beach, FL. The awards honor the outstanding work of ... and Pediatric Emergency Medicine Practice. , “With this award, we recognize the ...
Breaking Medicine News(10 mins):