PR84374

BAGSVAERD, Denmark, June 13, 2020 /PRNewswire=KYODO JBN/ --

This material is intended for global medical media only, excl US.

For journalistic assessment and preparation before publication.

- A separate real-world study showed that people with type 2 diabetes on two

oral antidiabetic drugs who intensified with a glucagon-like peptide-1 receptor

agonist (GLP-1 RA) were significantly more likely to reach their blood sugar

goals and lose weight compared to adding a further oral antidiabetic drug(s) or

insulin.[1]

Novo Nordisk today announced results from two real-world studies: EXPERT, which

confirms the efficacy Ozempic(R) (once–weekly semaglutide) demonstrated in the

SUSTAIN clinical trial programme, and PATHWAY, which supports recommendations

in clinical guidelines by showing that initiation of a GLP-1 receptor agonist

(GLP-1 RA) helps people with type 2 diabetes reach their blood sugar goals

(measured by HbA1c) while also losing weight. These studies, which analysed

data from US databases, were presented during the American Diabetes Association

80th Scientific Sessions.[1],[2]

The EXPERT study showed that a switch to Ozempic(R) from another GLP-1 RA in

people with type 2 diabetes was associated with statistically significant

reductions in blood sugar and weight, independent of the previous GLP-1 RA

used. After 6 months, the study showed HbA1c reductions of 2.2% for people with

HbA1c levels above 9% at baseline and HbA1c reductions of 1.1% for those with

HbA1c levels above 7% at baseline. These reductions were sustained after 12

months. Average weight loss of 2.2 kg was observed at 6 months, but was more

pronounced with 3.5 kg at 12 months, for all participants.[2]

A second real-world study, PATHWAY, pointed to the increased effectiveness of

the GLP-1 RA class compared with other oral antidiabetic drugs or insulin in

people with type 2 diabetes on two oral antidiabetic drugs requiring treatment

intensification.

Ozempic(R) was not one of the GLP-1 RA treatments given at intensification

because the study data were collated before Ozempic(R) was fully established on

the US market.

The PATHWAY study showed that intensifying treatment with a GLP-1 RA resulted

in a statistically significant increased likelihood of achieving HbA1c below 7%

and weight reduction from baseline compared with adding a further oral

antidiabetic(s). These blood glucose and weight reductions were more pronounced

compared with insulin intensification, where those taking a GLP-1 RA were

almost twice as likely to achieve HbA1c below 7% and approximately three times

more likely to lose weight.[1]  

"GLP-1 receptor agonists have been shown to safely lower blood glucose levels

and help lower weight, therefore they are recommended by all diabetes treatment

guidelines as either second- or third-line treatment options in most people

with type 2 diabetes," said study investigator Dr. Ildiko Lingvay, who consults

for Novo Nordisk and is a Professor of Internal Medicine, and Population and

Data Sciences at UT Southwestern Medical Center. "These data provide

information from the real-world use of GLP-1 receptor agonists and further

support the recommendations in the clinical guidelines by showing that

initiation of a GLP-1 receptor agonist helps more people with type 2 diabetes

reach their blood sugar goals while also helping them lose weight."

"More than half of people with type 2 diabetes do not reach their blood sugar

target, yet we know that consistently poor blood sugar control can lead to

serious complications," said Mads Krogsgaard Thomsen, executive vice president

and chief science officer of Novo Nordisk. "Real-world data is therefore

essential to help physicians select optimal treatment for their patients to

meet their blood sugar goals, and it is reassuring to see from the EXPERT study

that the efficacy Ozempic(R) demonstrated in the SUSTAIN Phase 3 clinical trial

programme is reflected in routine clinical practice."

Whilst real-world evidence generates valuable insights about the effectiveness

of a medicine in a real-life setting, there are also limitations. Real-world

studies may be subject to bias and confounding factors, aspects that are

controlled for in randomised controlled trials (RCTs). For example, electronic

data may be inconsistently collected, with missing data elements that can

result in reduced statistical validity. Similarly, adverse events are rarely

captured in databases that act as data sources for real-world studies.

Therefore real-world evidence should be considered alongside the results of

RCTs and the findings evaluated with appropriate caution. As seen in clinical

trials, the most common side effects of Ozempic(R) include nausea, vomiting,

diarrhoea, stomach (abdominal) pain, and constipation.

For additional media materials, including video footage of the EXPERT and

PATHWAY study investigators providing further context on the data, please

visit: www.epresspack.net/novonordiskADA2020/RWEGLP1Class

About EXPERT

The GLP-1-Experienced Patients Switching to Once-Weekly Semaglutide in a

Real-World Setting (EXPERT) study used prescription data from Explorys (IBM

Watson Health) US medical records database (data cut-off 12/5/19). Adults with

type 2 diabetes with greater than or equal to 1 prescription for semaglutide

(index/switch date), a prescription for any other GLP-1 RA (baseline) in the

previous year, and separate HbA1c/weight measurements at 6 and/or 12 months

post-index and in the 90-day pre-index period were identified from the

database. Participants with valid HbA1c (n=365) and weight (n=480) data were

included in the study and had similar baseline characteristics.[2]

About PATHWAY

The PATHWAY study compared treatment intensification options for glycaemic

control in people with type 2 diabetes on two oral antidiabetic drugs (OADs).

The PATHWAY study used linked electronic medical records and claims data from

IBM MarketScan Explorys Claims-EMR (index period: 3/1/13–10/31/18). The study

comprised two groups: the HbA1c cohort (n= 4,792) and the weight and composite

endpoint analysis cohort (n = 3,927). Participants with greater than or equal

to 1  claim for 2 different OADs in the 180 days pre-index, greater than or

equal to 1  claim for another OAD/GLP-1 RA/insulin (index date), greater than

or equal to 1 HbA1c and/or weight measurement 180 days post-index, and greater

than or equal to 1 HbA1c and/or weight measurement close to index date

(baseline) were included in the study. Cohorts for GLP-1 RAs vs OADs and vs

insulin were propensity score matched pairwise by baseline variables and exact

matched by HbA1c category, resulting in well balanced cohorts across all

baseline characteristics.[1]

About SUSTAIN clinical trial programme

The SUSTAIN clinical development programme for Ozempic(R) currently comprises

10 Phase 3 global clinical trials, including a cardiovascular outcomes trial,

which included people with type 2 diabetes and high cardiovascular risk. The

programme involves more than 10,000 adults with type 2 diabetes in total.3-12

About Ozempic(R)

Ozempic(R) (once-weekly semaglutide) is an analogue of the naturally occurring

hormone glucagon-like peptide-1 (GLP-1). It is administered in a once-weekly

injection of 0.5 mg or 1 mg and indicated as an adjunct to diet and exercise to

improve glycaemic control in adults with type 2 diabetes as well as to reduce

the risk of major adverse cardiovascular events in adults with type 2 diabetes

and established cardiovascular disease.13 Ozempic(R) was first approved by the

US FDA in 2017 and is now launched in 25 countries.

About Novo Nordisk

Novo Nordisk is a leading global healthcare company, founded in 1923 and

headquartered in Denmark. Our purpose is to drive change to defeat diabetes and

other serious chronic diseases such as obesity and rare blood and endocrine

disorders. We do so by pioneering scientific breakthroughs, expanding access to

our medicines and working to prevent and ultimately cure disease. Novo Nordisk

employs about 43,100 people in 80 countries and markets its products in around

170 countries. For more information, visit novonordisk.com, Facebook, Twitter,

LinkedIn, YouTube.

References

1. Desouza C, Kirk AR, Mangla KK, et al. Optimal Treatment Intensification for

Glycemic Control in Patients with T2D on Two Oral Agents: Real World Comparison

of GLP-1, OADs and Insulin. Abstract 931-P. 80th Scientific Sessions of the

American Diabetes Association, General Poster Session 2, 13:00 CDT on 13 June

2020.

2. Lingvay I, Kirk AR, Lophaven S, et al. GLP-1-Experienced Patients Switching

to Once-Weekly Semaglutide in a Real-World Setting (EXPERT Study). Abstract

954-P. 80th Scientific Sessions of the American Diabetes Association, General

Poster Session 2, 13:00 CDT on 13 June 2020.

3. Sorli C, Harashima SI, Tsoukas GM, et al. Efficacy and safety of once-weekly

semaglutide monotherapy versus placebo in patients with type 2 diabetes

(SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group,

multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol.

2017;5:251-260.

4. Ahrén B, Masmiquel L, Kumar H, et al. Efficacy and safety of once-weekly

semaglutide versus once-daily sitagliptin as an add-on to metformin,

thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): A

56-week, double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol.

2017;5:341-354.

5. Ahmann AJ, Capehorn M, Charpentier G, et al. Efficacy and Safety of

Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes

(SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care.

2018;41:258-266.

6. Aroda VR, Bain SC, Cariou B, et al. Efficacy and safety of once-weekly

semaglutide versus once-daily insulin glargine as add-on to metformin (with or

without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN

4): A randomised, open-label, parallel-group, multicentre, multinational, phase

3a trial. Lancet Diabetes Endocrinol. 2017;5:355-366.

7. Rodbard HW, Lingvay I, Reed J, et al. Semaglutide Added to Basal Insulin in

Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial. J Clin Endocrinol

Metab. 2018;103:2291-2301.

8. Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes

in patients with type 2 diabetes. N Engl J Med. 2016;375:1834-1844.

9. Pratley RE, Aroda VR, Lingvay I, et al. Semaglutide versus dulaglutide once

weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label,

phase 3b trial. Lancet Diabetes Endocrinol. 2018;6:275-286.

10. Lingvay I, Catarig A-M, Frias JP, et al. Efficacy and safety of once-weekly

semaglutide versus daily canagliflozin as add-on to metformin in patients with

type 2 diabetes (SUSTAIN 8): a double-blind, phase 3b, randomised controlled

trial. The Lancet Diabetes & Endocrinology. 2019;7:834-844.

11. Zinman B, Bhosekar V, Busch R, et al. Semaglutide once weekly as add-on to

SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised,

placebo-controlled trial. The Lancet Diabetes & Endocrinology. 2019;7:356-367.

12. Capehorn MS, Catarig AM, Furberg JK, et al. Efficacy and safety of

once-weekly semaglutide 1.0 mg vs once-daily liraglutide 1.2 mg as add-on to

1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10).

Diabetes Metab. 2019.  

13.EMA. Ozempic(R) Summary of Product Characteristics. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004174/WC500244163.pdf.

Last accessed: June 2020.

Further information

Media:                

Mette Kruse Danielsen        +45 3079 3883        mkd@novonordisk.com

Investors:                

Daniel Muusmann Bohsen        +45 3075 2175        dabo@novonordisk.com

Valdemar Borum Svarrer        +45 3079 0301        jvls@novonordisk.com

Ann Sondermolle Rendbaek  +45 3075 2253        arnd@novonordisk.com

Mark Joseph Root        +45 3079 4211        mjhr@novonordisk.com

Source: Novo Nordisk