New Phase 3 Study Shows Efficacy and Safety of Victoza® (Liraglutide [rDNA origin] Injection) for the Treatment of Type 2 Diabetes in Adults with Moderate Renal Impairment

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Jun 14, 2014, 01:00 ET

SAN FRANCISCO, June 14, 2014 /PRNewswire/ --

Data from a new phase 3 study demonstrated that once-daily Victoza® (liraglutide [rDNA origin] injection) provided greater glycaemic control versus placebo with no worsening of renal function in adults with type 2 diabetes and moderate renal impairment.[1],[2] The data were presented today at the 74th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco, CA. Renal impairment is one of the more challenging and common long-term complications of diabetes and limits the use of available antidiabetic treatment options.[3]

The 26-week, double-blind, randomized, controlled study investigated the efficacy and safety of Victoza® compared with placebo when added to preexisting oral antidiabetic treatment, insulin or a combination thereof. The study showed that adults with type 2 diabetes and moderate renal impairment, defined as those with stage 3 chronic kidney disease (eGFR 30-59 mL/min/1.73 m[2]; MDRD), treated with Victoza® had significantly greater improvements in mean HbA1c (a measure of blood glucose levels) (-1.05% vs. -0.38%; ETD -0.66% [95% CI: -0.90;-0.43]; p<0.0001), were more likely to achieve target HbA1c <7% (52.8% vs. 19.5%; p<0.0001), and experienced significantly greater weight loss from baseline (-2.41 kg/5.31 lbs vs. -1.09 kg/2.40 lbs; ETD

-1.32 kg/2.90 lbs [95% CI: -2.24;-0.40]; p=0.0052) versus placebo. No worsening of renal function and a lower incidence of hypoglycaemia with treatment of Victoza® compared with placebo were observed in the study.[1],[ 2]

"Renal impairment is very common in patients with type 2 diabetes, especially in adults over 65 years of age," said Melanie Davies, Professor of Diabetes Medicine and Honorary Consultant, Diabetes Research Centre, University of Leicester, U.K. "Of the therapies available for type 2 diabetes, it is essential we have treatment options for patients with associated renal impairment."

Overall, there is limited experience with Victoza® (liraglutide [rDNA origin] injection) in patients with mild, moderate, and severe renal impairment, including end-stage renal disease. Victoza® should be used with caution in this patient population.

The most common adverse events (AEs) seen in this study were gastrointestinal. These included nausea (21.4% vs. 4.4% placebo), vomiting (12.1% vs. 2.2%), diarrhoea (7.1% vs. 2.9%) and constipation (5.7% vs. 1.5%). Additional frequent AEs (≥5%) were renal impairment (5% vs. 5.8% placebo), nasopharyngitis, usually referred to as the common cold (5% vs. 11.7%), headache (5% vs. 2.9%), increased lipase (15% vs. 8.8%) and decreased glomerular filtration rate (6.4% vs. 5.1%).

About the study

The phase 3 study was a multinational study involving 277 adults. People with moderate renal impairment were defined as those with stage 3 chronic kidney disease. Participants were randomised to either Victoza® 1.8 mg, the highest dosage available, or placebo as add-on to existing oral antidiabetic treatment and/or insulin therapy. The mean age of participants was 68 years old and 66.3 for people treated with Victoza® or placebo, respectively. The primary endpoint was percentage change in HbA1c from baseline. Other endpoints included HbA1c to target <7% and body weight change from baseline. Renal function was measured by estimated glomerular filtration rate (eGFR) change from baseline.

About Victoza®

Victoza® is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration on January 25, 2010, as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.

As of January 2014, Victoza® has been commercially launched in 68 countries globally including the U.S., Canada, Japan, U.K., Germany, France, Italy, Denmark, Hungary, Russia, India, Brazil, Mexico, Argentina, Malaysia, and China, as well as a number of other countries, and will be available in other markets throughout 2014.

About Novo Nordisk

Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 40,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com.

Indications and Usage:

Victoza® (liraglutide [rDNA origin] injection) is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes when used along with diet and exercise.

Victoza® is not recommended as the first medication to treat diabetes. Victoza® has not been studied in patients with history of inflammation of the pancreas (pancreatitis). Victoza® is not a substitute for insulin and has not been studied in combination with prandial (mealtime) insulin. Victoza® is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if Victoza® (liraglutide [rDNA origin] injection) is safe and effective in children. Victoza® is not recommended for use in children.

Important Safety Information:

In animal studies, Victoza® caused thyroid tumors-including thyroid cancer-in some rats and mice. It is not known whether Victoza® causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people, which may be fatal if not detected and treated early. Do not use Victoza® if you or any of your family members have a history of MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). While taking Victoza®, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

Do not use Victoza® if you are allergic to liraglutide or any of the ingredients in Victoza®. Serious allergic reactions can happen with Victoza®. If symptoms of serious allergic reactions occur, stop taking Victoza® and seek medical attention. Pancreatitis may be severe and lead to death. Before taking Victoza®, tell your doctor if you have had pancreatitis, gallstones, a history of alcoholism, or high blood triglyceride levels since these medical conditions make you more likely to get pancreatitis.

Stop taking Victoza® and call your doctor right away if you have pain in your stomach area that is severe and will not go away, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis.

Before using Victoza®, tell your doctor about all the medicines you take, especially sulfonylurea medicines or insulin, as taking them with Victoza® may affect how each medicine works. If you use Victoza® with insulin, you may give both injections in the same body area (for example, your stomach area), but not right next to each other.

Also tell your doctor if you have severe stomach problems such as slowed emptying of your stomach (gastroparesis) or problems with digesting food; have or have had kidney or liver problems; have any other medical conditions; or are pregnant or plan to become pregnant. Tell your doctor if you are breastfeeding or plan to breastfeed. It is unknown if Victoza® will harm your unborn baby or if Victoza® passes into your breast milk.

Your risk for getting hypoglycaemia, or low blood sugar, is higher if you take Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea medicine or insulin may need to be lowered while taking Victoza®.

Victoza® may cause nausea, vomiting, or diarrhea leading to dehydration, which may cause kidney failure. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration.

The most common side effects with Victoza® include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza®, but decreases over time in most people. Immune system related reactions, including hives, were more common in people treated with Victoza® (liraglutide [rDNA origin] injection) compared to people treated with other diabetes drugs in medical studies.

Please click here for Prescribing Information and Medication Guide.

References

1. Davies M, Atkin S, Bain S, Rossing P, Scott D, et al. Efficacy and Safety of Liraglutide versus Placebo as Add-on to Existing Diabetes Medication in Subjects with Type 2 Diabetes (T2DM) and Moderate Renal Impairment (LIRA-RENAL). Guided Audio Poster Tour 0965-P at 74th Scientific Sessions of the American Diabetes Association (ADA), 15 June 2014.

2. Efficacy and Safety of Liraglutide versus Placebo as Add-on to Existing Diabetes Medication in Subjects with Type 2 Diabetes (T2DM) and Moderate Renal Impairment (LIRA-RENAL). Submitted to 74th Scientific Sessions of the American Diabetes Association (ADA), 15 June 2014.

3. Suarez M, Thomas D, Barisoni L, Fornoni A. Diabetic nephropathy: Is it time yet for routine kidney biopsy? World Journal of Diabetes 2013; 4(6): 245-255c.

SOURCE Novo Nordisk