New Xultophy(R)(IDegLira) Data Show Rapid and Predictable Glycaemic Improvements in People with Type 2 Diabetes

PR57956

VIENNA, Sept. 19/ PRN=KYODO JBN/ --

    Not intended for UK media

    Analyses of DUAL(TM) trial data compared Xultophy(R) (IDegLira)to insulin

degludec and liraglutide alone in both insulin-naive and insulin-treated

patients

    New analyses of phase 3a DUAL(TM) clinical data show that adults with type

2 diabetes treated with Xultophy(R), the once-daily single injection

combination of Tresiba(R)( insulin degludec) and Victoza(R) (liraglutide),

resulted in rapid and substantial improvement in glycaemic control, with a

beneficial weight profile, as early as 4 weeks after initiation in both

insulin-naive and insulin-treated patients compared to its individual

components.

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    Xultophy(R) treated patients also had a greater likelihood of reaching both

pre-prandial (before meal) and post-prandial (after meal) blood glucose targets

compared with either insulin degludec or liraglutide, suggesting increased

predictability with treatment. Data from the 52-week DUAL(TM) I and the 26-week

DUAL(TM) II clinical trials were presented at the 50th European Association for

the Study of Diabetes (EASD) annual meeting.

    "These new findings indicate that IDegLira could have a significant

positive impact on how people with type 2 diabetes view their treatment

progress, which could improve clinical outcomes," said Professor Tina Vilsboll,

Gentofte Hospital, University of Copenhagen, Denmark. "Getting to glycaemic

target faster and with more predictable control motivates patients to adhere to

therapy and proactively manage their disease."

    In the DUAL(TM) I clinical trial, the proportion of people achieving

fasting plasma glucose less than or equal to7.2 mmol/L at Week 4 and glycated

haemoglobin (HbA1c) ＜7% at Week 8 was greater with Xultophy(R) (76; 57%,

respectively) than with insulin degludec (62%; 38%) or with liraglutide (62%;

47%). At Weeks 4, 8 and 12 in DUAL(TM) I, treatment with Xultophy(R) also

resulted in significant weight loss compared with insulin degludec, which was

associated with a small overall weight gain (p＜0.0001 at Weeks 4, 8 and 12).

Weight loss with Xultophy(R) was less than that achieved with liraglutide 1.8

mg alone. Results from DUAL(TM) II were consistent with DUAL(TM) I findings for

Xultophy(R) and insulin degludec.[1]

    Results showed Xultophy(R) enabled more patients to reach the recommended

pre- and post-prandial target ranges, compared with administration of its

individual components. The proportion of people with type 2 diabetes at the end

of the trials with breakfast, lunch and dinner post-prandial blood glucose

values within the target of ＜9 mmol/L was significantly higher with

Xultophy(R) treatment (DUAL(TM) I: 51; DUAL(TM) II: 37%) than with insulin

degludec treatment (DUAL(TM) I: 38%; DUAL(TM) II: 25%) or with liraglutide

(DUAL(TM) I: 36%).[2]

    The likelihood of achieving all four pre-prandial blood glucose values

(before meals and bedtime) within the recommended range of greater than or

equal to3.9 to less than or equal to7.2 mmol/L was also significantly greater

with Xultophy(R) treatment (DUAL(TM) I: 48%; DUAL(TM)II: 44%) than with insulin

degludec treatment (DUAL(TM) I: 41%; DUAL(TM) II: 27%) or with liraglutide

treatment (DUAL(TM) I: 32%), which suggests the predictability of glycaemic

control within one day is increased with Xultophy(R).[2]

    In the clinical trial programme for Xultophy(R) there were no apparent

differences between Xultophy(R), insulin degludec and liraglutide with respect

to adverse events and standard safety parameters.[3,4]

    About Xultophy(R) (IDegLira)

    Xultophy(R) is a once-daily, single-injection combination product

consisting of Tresiba(R) (insulin degludec 50 units), a once-daily basal

insulin analogue with an ultra-long duration of action, and Victoza(R)

(liraglutide 1.8 mg), the once-daily human GLP-1 analogue. Xultophy(R) is

administered independently of meals and has shown consistent results in

improving glycaemic control in both insulin-naive people as well as people with

type 2 diabetes who are uncontrolled on basal insulin. For people uncontrolled

on basal insulin therapy, Xultophy(R) has demonstrated a significant reduction

in HbA1c of 1.9%, with a mean weight loss of 2.7 kg and a low rate of

hypoglycaemia comparable to that of insulin degludec.[3] Xultophy(R) is being

investigated in the clinical trial programme, DUAL(TM).

    Xultophy(R) was approved in Switzerland on 12 September 2014 and granted

marketing authorisation by the European Commission for all 27 European Union

member states on 18 September 2014.

    About the DUAL(TM) clinical programme

    DUAL(TM) (DUal Action of Liraglutide and Insulin Degludec in Type 2

Diabetes) includes two phase 3a trials encompassing around 2,000 people with

type 2 diabetes.

    DUAL(TM) I (1,663 people) - a 26-week, randomised, parallel, three-arm,

open-label, multicentre trial conducted at 271 sites across 19 countries. The

trial compared the efficacy and safety of Xultophy(R) versus insulin degludec

and liraglutide alone, in insulin-naive adults with type 2 diabetes

uncontrolled with metformin with or without pioglitazone. A 26-week extension

phase of the main trial was conducted to generate longer-term safety and

efficacy data. The topline results for DUAL(TM) I were reported in 2012.

    DUAL(TM) II (398 people) - a 26-week, randomised, parallel, two-arm,

double-blinded, multicentre trial conducted at 75 sites across 7 countries. The

trial compared the efficacy and safety of Xultophy(R) and insulin degludec once

daily, both added on to metformin in adults with type 2 diabetes uncontrolled

on basal insulin (20-40 units) in combination with metformin with or without

sulfonylureas/glinides. Sulfonylureas and glinides were discontinued at

randomisation. In this trial, the allowed maximum dose of insulin degludec in

the treatment arms was 50 units so that the contribution of the liraglutide

component of Xultophy(R) on glycaemic control could be demonstrated. The

topline results for DUAL(TM) II were reported in 2012.

    About Novo Nordisk

    Headquartered in Denmark, Novo Nordisk is a global healthcare company with

more than 90 years of innovation and leadership in diabetes care. The company

also has leading positions within haemophilia care, growth hormone therapy and

hormone replacement therapy. Novo Nordisk employs approximately 40,700

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

For more information, visit novonordisk.com.

    References

    1. Vilsboll T, et al. IDegLira, a combination of insulin degludec and

liraglutide, enables patients with type 2 diabetes to reach target glycaemic

control faster than its individual components alone. Poster presentation

(P-836) at the 50th European Association for the Study of Diabetes (EASD)

annual meeting, 17 September 2014.

    2. King A, et al. IDegLira, a combination of insulin degludec and

liraglutide, improves both pre- and postprandial plasma glucose in patients

with type 2 diabetes. Oral presentation (O-243) at the 50th European

Association for the Study of Diabetes (EASD) annual meeting, 19 September 2014.

    3. Buse JB, et al. Contribution of Liraglutide in the Fixed-Ratio

Combination of Insulin Degludec and Liraglutide (IDegLira), Diabetes Care. Epub

ahead of print. 11 August 2014. DOI:#10.2337/dc14-0785.

    4. Gough S, et al. Efficacy and safety of a fixed-ratio combination of

insulin degludec and liraglutide (IDegLira) compared with its components given

alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target

trial in insulin-naive patients with type 2 diabetes, Lancet Diabetes

Endocrinology. Epub ahead of print. 2 September 2014. DOI:#

10.1016/S2213-8587(14)70174-3.

    Further information:

    Media:

    Katrine Sperling +45-4442-6718 krsp@novonordisk.com

    Investors:

    Kasper Roseeuw Poulsen +45-3079-4303 krop@novonordisk.com

    Jannick Lindegaard Denholt +45-3079-8519 jlis@novonordisk.com

    Daniel Bohsen +45-3079-6376 dabo@novonordisk.com

    Frank Daniel Mersebach (US) +1-609-235-8567 fdni@novonordisk.com