Switching to investigational once-weekly insulin icodec from other basal insulins demonstrated to be efficacious and well-tolerated for people with type 2 diabetes in phase 2 trial

PR85732

BAGSVAERD, Denmark, Sept. 22, 2020 /PRNewswire=KYODO JBN/--

Today, Novo Nordisk announced results from three phase 2 clinical trials for

insulin icodec, an investigational once-weekly basal insulin analogue, which

were presented during the 56th European Association for the Study of Diabetes

(EASD) Annual Meeting 2020.

The first showed that switching to insulin icodec from other basal insulins

using two different switch approaches was efficacious and well-tolerated

compared to once-daily insulin glargine U100 and the switching approaches were

without an increased risk of clinically significant or severe hypoglycaemic

episodes compared to once-daily insulin glargine U100.1 This 16-week phase 2

clinical trial involved 154 adults with type 2 diabetes inadequately controlled

with oral antidiabetic drugs and once/twice-daily basal insulin randomised to

once-weekly insulin icodec with or without a loading dose or insulin glargine

U100.1,2 The primary endpoint of the trial, the blood sugar 'time in range'

3.9–10.0 mmol/L during weeks 15 and 16, showed that people receiving insulin

icodec with a loading dose demonstrated a significantly greater 'time in range'

compared to insulin glargine U100 (73% vs 65%, respectively). People who

received insulin icodec without a loading dose demonstrated similar blood sugar

'time in range' compared to insulin glargine U100 (66% vs 65%, respectively).1

"We know that many people with type 2 diabetes prefer simplicity, meaning fewer

injections and more convenience than what is currently provided with once- or

twice-daily basal insulin treatment regimens," said Dr Harpreet Bajaj, lead

trial investigator and endocrinologist, LMC Diabetes & Endocrinology, Ontario,

Canada. "This phase 2 trial demonstrates the potential benefit insulin icodec

could offer to people with type 2 diabetes in need of insulin therapy, aiding

easy transition onto a new treatment option without the daily burden and

complexity that is associated with current therapies and potentially even

experience more time in good glycaemic control with low risk of hypoglycaemia."

Key secondary endpoints included changes from baseline in HbA1c, which were not

statistically significantly different for icodec with and without a loading

dose compared to insulin glargine U100 (–0.77, –0.47 and –0.54 % points,

respectively). Rates of clinically significant or severe hypoglycaemic

episodes, also known as a hypo or low blood sugar, were similar between insulin

icodec with a loading dose and insulin glargine U100 (observed rates of level 2

[<3 mmol/L] and 3 [severe] hypoglycaemia were 0.78 and 0.79 events per patient

year of exposure for insulin icodec and insulin glargine U100, respectively),

and numerically lower for insulin icodec without a loading dose (0.15 events

per patient year of exposure). No new safety issues were identified in relation

to once-weekly insulin icodec and no severe episodes occurred in this trial.1

Data comparing the effect of different titration algorithms of insulin icodec

with insulin glargine U100 to better understand the optimal titration for a

once-weekly basal insulin in people with type 2 diabetes who were inadequately

controlled with oral antidiabetics were also presented at the meeting. In this

16-week trial, all three once-weekly titration algorithms for insulin icodec

investigated were shown to be well-tolerated and efficacious, and demonstrated

an improved or similar 'time in range' versus once-daily insulin glargine U100,

depending on the titration algorithm applied.3,4

Results from the 26-week phase 2 clinical trial in insulin-naïve adults with

type 2 diabetes where insulin icodec demonstrated comparable blood sugar

lowering and a similar safety profile to once-daily insulin glargine U100 were

also presented at the EASD Annual Meeting and simultaneously published in the

New England Journal of Medicine.5,6 The data were previously presented at the

80th Scientific Sessions of the American Diabetes Association in June 2020.7

"As a leader in diabetes innovation, Novo Nordisk understands that there is a

need to continue to offer innovative treatment options to support people living

with diabetes and improve outcomes," said Mads Krogsgaard Thomsen, executive

vice president and chief scientific officer of Novo Nordisk. "We are excited by

the phase 2 data that have been presented at EASD 2020 and ADA 2020 for insulin

icodec, which demonstrated its efficacy and tolerability, and has the potential

to offer a simplified treatment option for people with type 2 diabetes

initiating insulin treatment, as well as the option for those to switch."

The phase 2 trials will inform the trial designs for the phase 3 clinical development

programme for once-weekly insulin icodec, which Novo Nordisk will initiate later in 2020.

For more news and media materials from Novo Nordisk at EASD 2020, please visit:

https://www.epresspack.net/novonordiskEASD2020/phase-2-once-weekly-insulin 

About the phase 2 switching trial

This 16-week, randomised, open label, treat-to-target, phase 2 trial compared

the efficacy and safety of once-weekly insulin icodec with and without a

loading dose versus once-daily insulin glargine U100* in 154 people with type 2

diabetes inadequately controlled (HbA1c 7.0–10.0%) with oral antidiabetic drugs

and once/twice-daily insulin. A unit to unit switch (or a 20% reduction for

those receiving twice-daily basal insulin or insulin glargine U300 prior to

randomisation) with and without an initial 100% loading dose of insulin icodec

was investigated compared to insulin glargine U100. Insulin doses were titrated

weekly based on the lowest (if below target) or the mean of 3 pre-breakfast

self-measured blood glucose values to a target of 4.4–7.2 mmol/L. The primary

endpoint was 'time in range' 3.9–10.0 mmol/L (70–180 mg/dL) based on continuous

glucose monitoring (Dexcom G6®, Dexcom Inc, CA, USA) during weeks 15 and 16.

Secondary endpoints included HbA1c and body weight changes from baseline to

week 16, weekly insulin dose during weeks 15 and 16, and hypoglycaemic episodes.1,2

About insulin icodec

Insulin icodec is an investigational, long-acting basal insulin analogue with a

half-life of approximately one week.8 Once injected, insulin icodec binds

strongly but reversibly to albumin. This results in a continuous, slow and

steady release of active icodec to achieve effective lowering of blood sugar

throughout the week. The injection volume of once-weekly insulin icodec is

equivalent to daily insulin glargine U100 due to the concentrated formulation.9

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 43,500 people in 80 countries and markets its products in around

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

LinkedIn, YouTube.

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

_______________________

*NCT03922750: A Research Study in People With Type 2 Diabetes to Compare Two

Types of Insulin: Insulin 287 and Insulin Glargine

References

1. Bajaj HS, Isendahl J, Gowda A, et al. Efficacy and Safety of Switching to

Insulin Icodec, a Once-Weekly Basal Insulin, vs Insulin Glargine U100 in

Patients with T2D Inadequately Controlled on OADs and Basal Insulin. Abstract

657. Presented at the 56th European Association for the Study of Diabetes

(EASD) Annual Meeting 2020, The impact of new basal insulins, 12:00-13:00 CEST

on 22 September 2020.

2. ClinicalTrials.gov. A Research Study in People With Type 2 Diabetes to

Compare Two Types of Insulin: Insulin 287 and Insulin Glargine. Available at:

https://clinicaltrials.gov/ct2/show/NCT03922750. Last accessed: September 2020.

3. Lingvay I, Koefoed MM, Stachlewska K, et al. Effect of Three Different

Titration Algorithms of Insulin Icodec vs Insulin Glargine U100 on Time in

Range in Patients with T2D Inadequately Controlled on OADs. Abstract 658.

Presented at the virtual 56th European Association for the Study of Diabetes

(EASD) Annual Meeting 2020, The impact of new basal insulins, 12:00-13:00 CEST

on 22 September 2020.

4. ClinicalTrials.gov. A Research Study to Compare Two Types of Insulin:

Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not

Used Insulin Before. Available at:

https://clinicaltrials.gov/ct2/show/NCT03951805 . Last accessed: September 2020.

5. Rosenstock J, Kjaersgaard MIS, Moller DV, et al. Once-Weekly Basal Insulin

Icodec Offers Comparable Efficacy and Safety vs Once-Daily Insulin Glargine

U100 in Insulin Naïve Patients with T2D Inadequately Controlled on OADs.

Abstract 56. Presented at the virtual 56th European Association for the Study

of Diabetes Annual Meeting 2020, Developing better insulins, 14:45-15:00 CEST

on 22 September 2020.

6. Rosenstock J, Bajaj HS, Janez A, et al. Once-Weekly Insulin for Type 2

Diabetes Without Previous Insulin Treatment. New England Journal of Medicine.

2020; Published online ahead of print; DOI: 10.1056/NEJMoa2022474. Available

at: https://www.nejm.org/doi/full/10.1056/NEJMoa2022474.

7. Rosenstock J, Kjaersgaard MIS, Moller DV, et al. Once-Weekly Basal Insulin

Icodec Offers Comparable Efficacy and Safety vs Once-Daily Insulin Glargine

U100 in Insulin Naïve Patients with T2D Inadequately Controlled on OADs.

Abstract 238-OR. Presented at the 80th Scientific Sessions of the Virtual

American Diabetes Association Annual Meeting, Insulin Therapies, 18:15-18:30

CDT on 14 June 2020.

8. Hovelmann U, Brondsted L, Kristensen NR. et al. Insulin Icodec: An Insulin

Analog Suited for Once-Weekly Dosing in Type 2 Diabetes. Abstract 237-OR.

Presented at the 80th Scientific Sessions of the American Diabetes Association,

Insulin Therapies, 18:00-18:15 CDT on 14 June 2020.

9. Nishimura E, Kjeldsen T, Hubalek F, et al. Molecular and Biological

Properties of Insulin Icodec, a New Insulin Analog Designed to Give a Long

Half-Life Suitable for Once-Weekly Dosing. Abstract 236-OR. 80th Scientific

Sessions of the American Diabetes Association; Insulin Therapies, 17:45-18:00

CDT on 14 June 2020.

Source - Novo Nordisk