New Study With Victoza® (Liraglutide [rDNA Origin] Injection) Showed Improvements in Blood Glucose Control in Adults With Type 2 Diabetes Who Fasted During Ramadan

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Jun 06, 2015, 10:00 ET

BOSTON, Massachusetts, June 6, 2015 /PRNewswire/ --

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New findings showed that adults with type 2 diabetes treated with Victoza^® (liraglutide [rDNA origin] injection), in combination with metformin, experienced similar improvements in blood glucose control while fasting during Ramadan (four weeks) compared with sulfonylurea (SU) plus metformin.^[¹^] People treated with Victoza^® also demonstrated significantly better weight loss and fewer confirmed hypoglycaemic episodes compared with those treated with sulfonylurea during Ramadan.^[¹^] Findings from the LIRA-Ramadan™ study were presented today at the 75th Annual Scientific Sessions of the American Diabetes Association (ADA) in Boston, MA.

The 33-week, open-label, randomised study showed that Victoza^® sustained blood glucose control during four weeks of Ramadan, with similar reductions in fructosamine levels compared with sulfonylurea (-12.8 µmol/L vs. -16.4 µmol/L; estimated treatment difference [ETD] 3.51 µmol/L [-5.26;12.28]; P=0.43).^[¹^] Testing fructosamine allows the effectiveness of diabetes treatment to be reliably evaluated after a couple of weeks.^[²^]^,^[3^] During Ramadan, patients treated with Victoza^® experienced fewer confirmed hypoglycaemic episodes compared with people treated with sulfonylurea (2.0% vs. 4.3%), even though the Victoza^® group had lower fructosamine concentration at the start of Ramadan. In addition, greater weight loss was observed in people treated with Victoza^® during Ramadan vs. sulfonylurea (-1.43 kg/ -3.1 lbs vs. -0.89 kg/ -2.0 lbs; ETD -0.54 kg/ -1.2 lbs [-0.94/ -2.07; -0.14/ -0.31]; P=0.0091).^[¹^]

"Fasting during Ramadan presents unique medical challenges for people living with type 2 diabetes and their healthcare providers," said Dr. Sami Azar, Professor of Medicine at the American University of Beirut Medical Center, Beirut, Lebanon and principal investigator of the LIRA-Ramadan™ trial. "Prolonged fasting, often followed by large nighttime meals, can affect blood glucose levels and result in severe hypoglycaemia and hyperglycaemia. To help minimise these risks, physicians and people with type 2 diabetes should consider evaluating and discussing diabetes management plans in advance of Ramadan."

More than 50 million Muslims worldwide with diabetes fast during Ramadan,^[⁴^] the majority of whom have been estimated to have type 2 diabetes.^[⁵^] Muslims with type 2 diabetes who fast have an estimated 7.5-fold increased risk of severe hypoglycaemia and a five-fold increased risk of severe hyperglycaemia (requiring hospitalisation) during Ramadan,^[⁵^] which takes place 18 June - 17 July this year.

In the LIRA-Ramadan™ study, people treated with Victoza^® (liraglutide [rDNA origin] injection) from baseline to the end of Ramadan were more likely to achieve an HbA_1c target of <7% with no confirmed hypoglycaemic episodes compared with sulfonylurea (53.9% vs. 23.5%; OR 3.80 [2.24;6.46]; P<0.0001). Also, people treated with Victoza^® compared with sulfonylurea experienced significantly greater weight loss
(-5.40 kg/ -11.9 lbs vs. -1.46 kg/ -3.2 lbs; ETD -3.94 kg/ -8.7 lbs [-4.54/ -10.0; -3.33/ -7.3]; P<0.0001), had significantly greater improvements in HbA_1c (-1.24% vs. -0.65%; ETD -0.59% [-0.79; -0.38]; P<0.0001), were more likely to achieve the target level of HbA_1c <7% (57.1% vs. 26.4%; OR 3.71 [2.18;6.30]; P<0.0001), and experienced significant reductions in fructosamine levels (-39.6 µmol/L vs. -29.3 µmol/L; ETD -10.3 µmol/L [-18.7; -1.89]; P=0.0165).

The percentage of patients experiencing adverse events (AEs) during Ramadan was similar in the Victoza^® and sulfonylurea groups (23.7% vs. 20.9%), with gastrointestinal side effects more common with Victoza^® treatment (10.5% vs. 3.7%). Overall, a low incidence of severe AEs was observed (Victoza^®, 1.3% vs. sulfonylurea, 0%).^[¹^]

The most common AEs seen during the entire study period were gastrointestinal (Victoza^®, 56.7% vs. sulfonylurea, 9.4%), and these included nausea, diarrhoea, vomiting, abdominal pain and abdominal distension.^[¹^]

About the Study

The study was a 33-week, open-label, multinational clinical trial involving 343 people (172 for Victoza^®, 171 for sulfonylurea). The study included people with type 2 diabetes with intent to fast during Ramadan, HbA_1c 7-10%, BMI ≥20 kg/m², and treated with a stable dose of metformin and sulfonylurea (at maximum tolerated dose). Study participants were randomised to either switch to Victoza^® (1.8 mg) or continue pretrial sulfonylurea, both in combination with pretrial metformin. Victoza^® doses were escalated over 3 weeks, and followed by a 6- to 19-week treatment maintenance period preceding Ramadan. The primary endpoint was change in fructosamine from start to end of Ramadan (4-week period). Secondary endpoints included number of confirmed hypoglycaemic episodes during Ramadan as well as HbA_1c reduction, HbA_1c target <7% with no hypoglycaemic episodes, and weight change at end of Ramadan from baseline.

About Victoza^® (liraglutide [rDNA origin] injection)

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 glycaemic control in adults with type 2 diabetes.

As of March 2015, Victoza^® has been commercially launched in 75 countries, including the United States, Canada, Japan, United Kingdom, Germany, France, Italy, Denmark, Hungary, Russia, India, Brazil, Mexico, Argentina, Malaysia, and China. It will be available in other markets throughout 2015.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,000 people in 75 countries, and markets its products in more than 180 countries. For more information, visit Facebook, Twitter, LinkedIn, YouTube.

Indications and Usage

What is Victoza^®?

Victoza^® is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes, and should be used along with diet and exercise.

Victoza^® is not recommended as the first choice of medicine for treating diabetes.
It is not known if Victoza^® can be used in people who have had pancreatitis.
Victoza^® is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
It is not known if Victoza^® can be used with mealtime insulin.
It is not known if Victoza^® is safe and effective for use in children.

Important Safety Information

What is the most important information I should know about Victoza^®?

Victoza^® may cause serious side effects, including:

Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Victoza^® and medicines that work like Victoza^® caused thyroid tumors, including thyroid cancer. It is not known if Victoza^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Who should not use Victoza^®?

Do not use Victoza^® if:

you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
you are allergic to liraglutide or any of the ingredients in Victoza^®.

What should I tell my health care provider before using Victoza^® (liraglutide [rDNA origin] injection)?

Before using Victoza^®, tell your health care provider if you:

have or have had problems with your pancreas, kidneys, or liver.
have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
are pregnant or breastfeeding or plan to become pregnant or breastfeed.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.

How should I use Victoza^®?

Do not mix insulin and Victoza^® together in the same injection.
You may give an injection of Victoza^® and insulin in the same body area (such as your stomach area), but not right next to each other.
Do not share your Victoza^® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

What are the possible side effects of Victoza^®?

Victoza^® may cause serious side effects, including:

inflammation of your pancreas (pancreatitis). Stop using Victoza^® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Victoza^® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
serious allergic reactions. Stop using Victoza^® and get medical help right away if you have any symptoms of a serious allergic reaction including itching, rash, or difficulty breathing.

The most common side effects of Victoza^® may include headache, nausea, diarrhea, vomiting, and anti-liraglutide antibodies in your blood.

Please click here for Prescribing Information and Medication Guide.

References

1. Azar S, Echtay A, Mohamad W, et al. Efficacy and safety of liraglutide versus sulfonylurea both in combination with metformin during Ramadan in subjects with type 2 diabetes (LIRA-Ramadan): A randomized trial. Poster presented at 75th Scientific Sessions of the American Diabetes Association (ADA). June 2015.

2. Malmstrom H, Walldius G, Grill V, et al. Fructosamine is a useful indicator of hyperglycaemia and glucose control in clinical and epidemiological studies--cross-sectional and longitudinal experience from the AMORIS cohort. PLoS One. 2014; 9:e111463.

3. Lab Tests Online. Fructosamine testing. Available at: http://labtestsonline.org.uk/understanding/analytes/fructosamine/tab/test/. Accessed on: 23/05/2015.

4. Al-Arouj M, Assaad-Khalil S, Buse J, et al. Recommendations for management of diabetes during Ramadan: update 2010. Diabetes Care. 2010; 33:1895-1902.

5. Salti I, Benard E, Detournay B, et al. A population-based study of diabetes and its characteristics during the fasting month of Ramadan in 13 countries: results of the epidemiology of diabetes and Ramadan 1422/2001 (EPIDIAR) study. Diabetes Care. 2004; 27:2306-2311.

Further Information

Media:

Katrine Sperling +45-4442-6718 [email protected]
Michael Bachner (US) +1-609-664-7308 [email protected]

Investors:

Kasper Roseeuw Poulsen +45-3079-4303 [email protected]
Melanie Raouzeos +45-3075-3479 [email protected]
Daniel Bohsen +45-3079-6376 [email protected]
Frank Daniel Mersebach (US) +1-609-235-8567 [email protected]

SOURCE Novo Nordisk