New IDegLira Phase 3b Study Showed Statistically Significant HbA1c Reduction, Body Weight Change, and Lower Rate of Hypoglycaemia Versus Insulin Glargine

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Jun 07, 2015, 08:00 ET

BOSTON, June 7, 2015 /PRNewswire/ --

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New phase 3b findings showed adults with type 2 diabetes treated with IDegLira, the investigational once-daily, single-injection combination of insulin degludec and liraglutide in the United States, demonstrated statistically significant reduction in HbA_1c (average blood glucose over the previous three months), change in body weight, and a lower rate of hypoglycaemia compared with patients treated with insulin glargine.^[^1]

Findings from the phase 3b DUAL™ V 26-week trial that compared the efficacy and safety of IDegLira versus insulin glargine, both added on to metformin, in patients with type 2 diabetes uncontrolled on insulin glargine (20-50 units/day) were presented today at the 75th Annual Scientific Sessions of the American Diabetes Association (ADA) in Boston, MA.^[^1]

At 26 weeks, patients randomised to IDegLira treatment achieved a statistically significant mean reduction in HbA_1c of 1.8% from baseline (8.4% to 6.6%), compared with a 1.1% reduction (8.2% to 7.1%) achieved by patients who further increased their dose of insulin glargine (p˂0.001).^[^1] In the IDegLira group, 72% of patients achieved an HbA _1c of <7% at the end of the trial, compared with 47% of patients in the insulin glargine group (p˂0.001)^[^1]. Furthermore, 39% of patients treated with IDegLira achieved an HbA_1c <7% without hypoglycaemia and weight gain, versus 12% treated with insulin glargine (p˂0.001).^[^1]

"The results demonstrated that IDegLira treatment could positively impact patients who are not in control on their current basal insulin therapy," said Professor John Buse, University of North Carolina School of Medicine, Chapel Hill, NC. "IDegLira patients achieved an end-of-trial mean HbA_1c of 6.6% while still experiencing weight reduction, and had significantly less hypoglycaemia than patients taking higher doses of insulin glargine."

There was a 57% lower rate of confirmed hypoglycaemia with IDegLira compared with insulin glargine (2.23 episodes/patient-year vs 5.05 episodes/patient-year; p˂0.001).^[^1] Additionally, there was a significant difference of 3.2 kg (7.1 lb) in change in body weight between treatment groups (p˂0.001); body weight decreased by 1.4 kg (3.0 lb) from baseline for patients treated with IDegLira and increased by 1.8 kg (4.0 lb) for patients treated with insulin glargine.^[^1]Patients treated with IDegLira required significantly less insulin than patients treated with insulin glargine, demonstrated by the end-of-trial dose of 41 units of the insulin degludec component in IDegLira versus 66 units (p˂0.001).^[^1]

In the DUAL™ V trial, there were similar rates of overall and serious adverse events in the two treatment groups.^[^1] The most frequently occurring adverse events (≥5%) seen during the DUAL™ V trial for IDegLira and insulin glargine, respectively, were nausea (9.4%, 1.1%), diarrhea (7.2%, 2.5%), vomiting (5.0%, 1.8%), and headache (4.0%, 5.0%).^[^2]

Also presented during the scientific meeting were additional patient-reported outcomes (PRO) data measured by TRIM-D (Treatment Related Impact Measure-Diabetes) and SF‐36 v2 (Short-Form 36 Health Survey version 2) from DUAL™ V:

Insulin Degludec/Liraglutide (IDegLira) Improves Patient-Reported Impacts in Subjects with Type 2 Diabetes (T2D) Inadequately Controlled on Insulin Glargine (IG) Plus Metformin (Met): DUAL V Study (Abstract #2550-PO)

About IDegLira

IDegLira is an investigational once-daily, single-injection combination of Tresiba^® (insulin degludec), an investigational, once-daily basal insulin analogue with an ultra-long duration of action, and Victoza^® (liraglutide [rDNA origin] injection), a once-daily human GLP-1 analogue. IDegLira is being investigated in the DUAL™ clinical trial programme, which includes two phase 3a and a number of phase 3b trials, encompassing more than 3,500 adults with type 2 diabetes. IDegLira was granted marketing authorisation by the European Commission on 18 September 2014and is marketed in Europe under the brand name Xultophy^®.^[3]

Insulin degludec is currently under review by the U.S. Food and Drug Administration (FDA). Insulin degludec has received regulatory approval in other countries and is marketed as Tresiba^®.

About DUAL™ V

DUAL™ V was a phase 3b, 26-week, treat-to-target, randomised, open-label, multicentre trial conducted in 10 countries and included 557 patients. The trial compared the efficacy and safety of IDegLira versus insulin glargine, both added on to metformin, in adults with type 2 diabetes uncontrolled on insulin glargine (20-50 units). The trial was designed to show noninferiority in HbA_1c and to subsequently demonstrate superiority in HbA_1c, body weight, and hypoglycaemia. The pretrial mean dose of insulin glargine was 32 units. Patients could be titrated to the maximum dose of IDegLira (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide), and there was no maximum daily dose of insulin glargine.^[1],[4]

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.

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

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. Buse J et al. Insulin Degludec/Liraglutide (IDegLira) Is Superior to Insulin Glargine (IG) in A1c reduction, Risk of Hypoglycaemia and Weight Change: DUAL V Study. Oral presentation (#160-OR) at the 75th Scientific Sessions of the American Diabetes Association (ADA), 7 June 2015. Boston, MA.

2. Novo Nordisk A/S. Data on file.

3. EMA. Xultophy^® Summary of Product Characteristics. http://ec.europa.eu/health/documents/community-register/2014/20140918129550/anx_129550_en.pdf. Accessed 2 March 2015.

4. ClinicalTrials.gov. NCT01952145. A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus (DUAL™ V). https://www.clinicaltrials.gov/ct2/show/study/NCT01952145?show_locs=Y#locn. Accessed 2 March 2015.

Tresiba^®, Victoza^®, and Xultophy^® are registered trademarks of Novo Nordisk A/S.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

SOURCE Novo Nordisk