PR65684

Adults with Type 2 Diabetes Treated with Xultophy(R) (IDegLira) were up to 4.5 Times More Likely to Reach Glycaemic Targets Without Hypoglycaemia and Weight Gain vs Up-titration with Insulin Glargine U100

MUNICH, Germany, Sept. 13, 2016 /PRNewswire=KYODO JBN/--

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    Novo Nordisk today presented data showing the odds of reaching fasting

plasma glucose (FPG) targets without hypoglycaemia and weight gain were

significantly greater for Xultophy(R) (IDegLira) compared to up-titration with

insulin glargine U100 in adults with type 2 diabetes uncontrolled on insulin

glargine U100 (20-50 units). Xultophy(R) is the first once-daily combination of

a long-acting insulin (insulin degludec) and a glucagon-like peptide-1 (GLP-1)

receptor agonist (liraglutide) in Europe. Results were presented at the 52nd

Annual Meeting of the European Association for the Study of Diabetes (EASD)

2016.[1]

    The post-hoc analysis of the DUAL V phase 3b trial was evaluated using a

FPG target of 7.2 mmol/L, selected to better reflect targets used in clinical

practice.[2] Data showed that adults treated with Xultophy(R) were 4.55 times

more likely to reach FPG targets without confirmed hypoglycaemia and weight

gain vs up-titration with insulin glargine U100 (41.4% vs 14.3%, p＜0.0001).[1]

    The data also demonstrated that significantly more adults achieved HbA1c

target of ＜7% with no hypoglycaemia and no weight gain across baseline HbA1c

groups (less than or equal to7.5, ＞7.5-less than or equal to8.5 and ＞8.5%) with

Xultophy(R) vs up-titration with insulin glargine U100 (51% vs 25%; 39% vs 11%;

32% vs 5%; p＜0.005 for all).[1]

    In addition, FPG and HbA1c were already significantly reduced at weeks 4, 8

and 12 in adults switching to Xultophy(R) vs up-titration with insulin glargine

U100, demonstrating better glycaemic control shortly after transferring to

Xultophy(R) compared to insulin glargine U100.[1]

    "This analysis of DUAL V indicates that Xultophy(R) is effective in helping

patients achieve glycaemic control with a lower risk of hypoglycaemia and

weight gain compared to up-titration with insulin glargine U100, based on

targets used in clinical practice," said Dr. Ildiko Lingvay*, Associate

Professor of Internal Medicine and Clinical Science at UT Southwestern Medical

Center. "The data demonstrate improvements in glycaemic control as early as

four weeks after treatment initiation."

    Also presented at EASD, Novo Nordisk announced results from DUAL VI

demonstrating that using a simpler titration algorithm of once-weekly dose

adjustments compared to the twice-weekly adjustments used in previous DUAL

trials, results in a non-inferior safety and glycaemic efficacy profile for

Xultophy(R) in insulin-naive adults with type 2 diabetes.[3]

    *Dr. Lingvay, who is involved with several Novo Nordisk-sponsored clinical

trials, including  DUAL V, received editorial support and reimbursements from

Novo Nordisk in 2016.

    About Xultophy(R)

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

analogue (insulin degludec) and GLP-1 analogue (liraglutide). The maximum dose

of Xultophy(R) is 50 dose steps (equivalent to 50 units of insulin degludec and

1.8 mg of liraglutide).[4] Xultophy(R) has been investigated in six trials in

the DUAL clinical trial programme, encompassing more than 3,850 people with

type 2 diabetes. Phase 3b trials are still ongoing. Xultophy(R) was granted

marketing authorisation by the European Commission on 18 September 2014 and

approved in Switzerland on 12 September 2014.[4],[5] Xultophy(R) is not

distributed in Germany.

    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 demonstrate

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

the efficacy and safety of Xultophy(R) vs 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 (R)

(equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide) and

there was no maximum daily dose of insulin glargine.[6]

    About DUAL VI

    DUAL VI was a 32-week, open-label, non-inferiority trial to investigate the

safety and efficacy of Xultophy(R) in insulin-naive adults with type 2 diabetes

uncontrolled on metformin plus or minus piglitazone. In the trial, 420

participants were randomised 1:1 to receive Xultophy(R), 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

(i.e. six readings/week, as for DUAL I-V trials; n=210).[3]

    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 42,300 people in

75 countries and markets its products in more than 180 countries.

   For more information, visit:

   novonordisk.com [http://www.novonordisk.com ],

   Facebook [http://www.facebook.com/novonordisk ],

   Twitter [http://www.twitter.com/novonordisk ],

   LinkedIn [http://www.linkedin.com/company/novo-nordisk ],

   YouTube [http://www.Youtube.com/novonordisk ]

     Further Information

     Media:

     Katrine Sperling

     +45-4442-6718

     krsp@novonordisk.com;

     Asa Josefsson

     +45-3079-7708

     aajf@novonordisk.com

     Investors:

     Peter Hugreffe Ankersen

     +45-3075-9085

     phak@novonordisk.com;

     Melanie Raouzeos

     +45-3075-3479

     mrz@novonordisk.com;

     Hannah Ogren

     +45-3075-8519

     haoe@novonordisk.com

     Kasper Veje (US)

     +1-609-235-8567

     kpvj@novonordisk.com

     References

    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. American Diabetes A. Standards of Medical Care in Diabetes-2016 Clin

Diabetes. 2016; 34.

    3. 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.

    4. EMA. Xultophy(R) summary of product characteristics. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002647/WC500177657.pdf

Last accessed: August 2016.

    5. SwissMedic. Xultophy(R): information for professionals. 2014.

    6. 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.

    SOURCE: Novo Nordisk