PR60794

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

BOSTON, June 7 / PRN=KYODO JBN / --

   - 166-OR

   This material is intended for medical non-UK media only.

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   New phase 3b findings showed adults with type 2 diabetes treated with

Xultophy(R) (IDegLira), a once-daily, single-injection combination of insulin

degludec and liraglutide, demonstrated statistically significant reduction in

HbA1c(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]

   To view the Multimedia News Release, please click:

http://www.multivu.com/players/English/7542051-xultophy-phase-3b-study/

   Findings from the phase 3b  DUAL(TM) V 26-week trial that compared the

efficacy and safety of Xultophy(R) 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, Massachusetts, United

States.[1]

   At 26 weeks, patients randomised to Xultophy(R) treatment achieved a

statistically significant mean reduction in HbA1c 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

Xultophy(R) group, 72% of patients achieved an HbA1c 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 Xultophy(R)

achieved an HbA1c ＜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, North Carolina, US. "IDegLira patients achieved an end of trial mean

HbA1c 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 Xultophy(R)

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 Xultophy(R) and increased by 1.8 kg (4.0 lb) for patients treated

with insulin glargine.[1]  Patients treated with Xultophy(R) 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 Xultophy(R) versus 66 units respectively (p＜0.001).[1]

   In the  DUAL(TM) V trial, there were similar rates of overall and serious

adverse events in the two treatment groups.[1]

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(TM) 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(TM) V Study (Abstract #2550-PO).

   About Xultophy(R)    

   Xultophy(R) is a once-daily single injection combination of Tresiba(R)

(insulin degludec), a once-daily basal insulin analogue with an ultra-long

duration of action and Victoza(R) (liraglutide), a once-daily human GLP-1

analogue.[2] The maximum dose of Xultophy(R) is 50 dose steps (equivalent to 50

units of insulin degludec and 1.8 mg of liraglutide). Xultophy(R) is being

investigated in the  DUAL(TM) clinical trial programme which includes two phase

3a and a number of phase 3b trials, encompassing more than 3,500 people with

type 2 diabetes. Xultophy(R) was granted marketing authorisation by the

European Commission on 18 September 2014 and approved in Switzerland on 12

September 2014.[2],[3]

   About  DUAL(TM)V  

   DUAL(TM) V was a phase 3b, 26-week, treat-to-target, randomised, open-label,

multicentre trial conducted in 10 countries with 557 patients. The trial was

designed to show non-inferiority in HbA1c and to subsequently demonstrate

superiority in HbA1c, body weight and hypoglycaemia. The trial compared the

efficacy and safety of Xultophy(R) versus insulin glargine, both added on to

metformin, in adults with type 2 diabetes uncontrolled on insulin glargine

(20-50 units). The pre-trial mean dose of insulin glargine was 32 units.

Patients could be titrated to the maximum dose of Xultophy(R) (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: novonordisk.com, Facebook, Twitter, LinkedIn, YouTube

   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 (#166-OR) at the 75th Scientific

Sessions of the American Diabetes Association (ADA), 7 June 2015.

   2. EMA. Xultophy(R) Summary of Product Characteristics. Available at:

http://ec.europa.eu/health/documents/community-register/2014/20140918129550/anx_129550_en.pdf

Last accessed: 03.02.2015.

   3. SwissMedic. Xultophy(R): Information for Professionals. 22.09.2014.

   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(TM) V). Available at:

https://www.clinicaltrials.gov/ct2/show/study/NCT01952145?show_locs=Y#locn Last

accessed: 03.02.2015.

   SOURCE: Novo Nordisk A/S