Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms RSS Feed RSS Feeds RSS Feed PharmiWeb Candidate Blog RSS Feed PharmiWeb Client Blog


Press Release

Adults with type 2 diabetes treated with Xultophy ®? (insulin degludec/liraglutide) are up to 4.5 times more likely to achieve glycaemic targets without hypoglycaemia and weight gain versus insulin glargine U100

Novo Nordisk
Posted on: 13 Sep 16

Gatwick, UK, 13 September 2016 — Results from a post-hoc analysis of Novo Nordisk’s phase 3b DUAL V trial have shown that patients with type 2 diabetes treated with Xultophy® (insulin degludec/liraglutide) are up to 4.5 times more likely to achieve glycaemic targets without hypoglycaemia and weight gain*, compared with patients treated with insulin glargine U1001. The post-hoc analysis results were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) 2016 in Munich, Germany1.

The analysis compared whether two groups of type 2 diabetes patients uncontrolled on insulin glargine U100, treated with either insulin degludec/liraglutide or up-titrated insulin glargine U100 and achieving glycaemic targets (HbA1c <7% or a fasting plasma glucose [FPG] target of <7.2 mmol/L) also achieved composite endpoints reflecting the targets aimed for in clinical practice1.

In the UK, 90% of adults living with type 2 diabetes are either overweight or obese2. Therefore, the ability to achieve glycaemic control without the added burden of weight gain is important for this group. Fear of hypoglycaemia is also a commonly reported problem3. Hypoglycaemia can impact quality of life, affecting sleep patterns, relationships and the ability to work4, 5, 6.

Adie Viljoen, Consultant Chemical Pathologist and Lipidologist at East and North Hertfordshire NHS Trust, and investigator for the DUAL I study commented: “The results from the DUAL V analysis are encouraging. Hypoglycaemia and weight gain are two of the most common complications of insulin treatments. The ability to reach glycaemic targets with insulin degludec/liraglutide, while reducing the risk of unwanted side effects, such as hypoglycaemia, has the potential to improve patients’ quality of life and long-term health.”

*Confirmed hypoglycaemia (<3.1 mmol/L or requiring assistance) in the last 12 weeks of treatment and/or weight gain from baseline to week 26.

Results of the DUAL V post-hoc analysis showed1:

·         Adults treated with insulin degludec/liraglutide were 4.55 times more likely to achieve fasting plasma glucose (FPG) targets (<7.2 mmol/L) without confirmed hypoglycaemia and weight gain* versus up-titration with insulin glargine U100 (41.4% vs 14.3%, p<0.0001)1

·         Significantly more adults treated with insulin degludec/liraglutide achieved a HbA1c target of <7% with no hypoglycaemia and no weight gain across baseline HbA1c groups versus up-titration with insulin glargine U1001

Baseline HbA1c group, % (mmol/mol)

% of adults achieving HbA1c target of <7% with no hypoglycaemia and no weight gain, insulin degludec/liraglutide

% of adults achieving HbA1c target of <7% with no hypoglycaemia and no weight gain, insulin glargine U100


≤7.5% (≤58.5 mmol/mol)  




>7.5% (>58.5 mmol/mol) to  

≤8.5% (≤69.4 mmol/mol)




>8.5 (>69.4 mmol/mol)




·         FPG and HbA1c were already significantly reduced at weeks 4, 8 and 12, showing better glycaemic control shortly after transferring to insulin degludec/liraglutide versus up-titration with insulin glargine U1001

Results from the DUAL VI study were also presented at EASD, which showed that using a more simple titration algorithm of once-weekly dose adjustments of insulin degludec/liraglutide versus the twice-weekly adjustments used in previous DUAL trials had a non-inferior safety profile and glycaemic-efficacy profile for insulin degludec/liraglutide in insulin-naïve patients7.



About Xultophy® (insulin degludec/liraglutide)

Xultophy® is a once-daily single injection co-formulation of basal insulin analogue (insulin degludec) and GLP-1 agonist (liraglutide). The maximum dose of insulin degludec/liraglutide is 50 dose steps (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide)8. This treatment has been investigated in six trials in the DUAL clinical trial programme, encompassing more than 3850 people with type 2 diabetes. Phase 3b trials are still ongoing.

About DUAL V

DUAL 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 show superiority in HbA1c, body weight and rate of hypoglycaemia. The trial compared the efficacy and safety of Xultophy® versus up-titration of insulin glargine U100, 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® (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide) and there was no maximum daily dose of insulin glargine9.


DUAL VI was a 32-week, open-label, non-inferiority trial to investigate the safety and efficacy of Xultophy® in insulin-naive adults with type 2 diabetes uncontrolled on metformin ± piglitazone. In the trial, 420 participants were randomised 1:1 to receive Xultophy®, titrated either once weekly based on the mean of two pre-breakfast plasma glucose (PG) readings (n=210) or twice weekly based on the mean of three pre-breakfast PG readings (ie, six readings/week, as for DUAL I-V trials; n=210)7.

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 41,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit


Further information

Stephen Cull

Mario Christodoulou

+44 (0) 7584 447 280

+44 (0) 7789 507 812

Rupal Patel

+44 (0) 7870 678 084  



1.    Lingvay I, Norwood P, Begtrup K et al., Patients with T2D Treated with IDegLira Have a Greater Chance of Reaching Glycaemic targets without Hypoglycaemia and Weight Gain than with Insulin Glargine U100 (IGlar U100). Abstract 890 presented at the 52nd European Association for the Study of Diabetes (EASD), Munich, Germany. 13 September 2016.

2.    Public Health England. Adult obesity and type 2 diabetes, 2014. Available at:  Last accessed: September 2016. 

3.    Sakane N, Kotani K, Tsuzaki K et al., Fear of hypoglycemia and its determinants in insulin-treated patients with type 2 diabetes mellitus. J Diabetes Investig. 2015 Sep; 6(5): 567–570.

4.    Diabetes World Awake Study. Conducted by Aequus August 2013. Funded by Novo Nordisk A/S.

5.    Kovacs Burns K, Nicolucci A, Holt R et al., Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking indicators for family members living with people with diabetes. Diabet Med 2013 Jul; 30(7):778-88.

6.    Brod M, Christensen T, Thomsen T et al., The impact of non-severe hypoglycemic episodes on work productivity and diabetes management. Value Health 2011; 14(5):665–71.

7.    Harris S, Kocsis G, Prager T et al., Safety and efficacy of IDegLira titrated once weekly (1W) vs twice weekly (2W) in patients with T2D uncontrolled on oral antidiabetic drugs: DUAL VI study. Abstract 908 presented at the 52nd European Association for the Study of Diabetes (EASD), Munich, Germany. 15 September 2016.

8.    EMA. Xultophy® summary of product characteristics. Available at: Last accessed: September 2016.

9.    Lingvay I, Manghi FP, Garcia-Hernandez P, et al., Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial. Supplementary Information. JAMA. 2016; 315:898-907.

Editor's Details

Rupal Patel
+44 (0) 7870 678 084

Last updated on: 13/09/2016

Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.