Faster-acting insulin aspart improved postprandial glucose
(PPG) control in type 1 and type 2 diabetes
MISSISSAUGA, ON, June 13, 2016 /CNW/ - New phase 3a findings
showed that faster-acting insulin aspart demonstrated a
statistically significant reduction in HbA1c in type 1
diabetes, compared with NovoRapid® (insulin
aspart),1 a comparable HbA1c reduction in
type 2 diabetes versus NovoRapid®2 and improved
post-meal or postprandial glucose (PPG) control in type 1 and type
2 diabetes.1,2 Results from the onset® 1 and
onset® 2 treat-to-target trials comparing faster-acting
insulin aspart with NovoRapid® were presented at the
76th annual Scientific Sessions of the American Diabetes
Association (ADA) in New Orleans, USA.
In onset® 1, after 26 weeks of randomized therapy,
faster-acting insulin aspart showed statistically significantly
greater HbA1c reduction versus NovoRapid® in
adults with type 1 diabetes when dosed at mealtime ([95% confidence
interval (CI)] -0.15 [-0.23; -0.07]). Faster-acting insulin aspart
also showed comparable HbA1c reduction when dosed 20
minutes after starting a meal, compared with NovoRapid®
dosed at mealtime ([95% CI] 0.04 [-0.04; 0.12]).1
Trial results for onset® 1 also showed superior
reduction in two-hour PPG increment[*] ([95% CI] -0.67 [-1.29;
-0.04] mmol/L) versus NovoRapid®. The change in one-hour
PPG increment*, a secondary supportive endpoint, was
also reduced ([95% CI] -1.18 [-1.65; -0.71]
mmol/L).1
In onset® 2, faster-acting insulin aspart
demonstrated non-inferiority in HbA1c reduction compared
with NovoRapid® ([95% CI] -0.02 [-0.15; 0.10]) in adults
with type 2 diabetes. Trial results could not confirm a
statistically significant reduction in two-hour PPG increment[†]
([95% CI] -0.36 [-0.81; 0.08] mmol/L). However, a statistically
significant reduction in one-hour PPG increment* was
shown with faster-acting insulin aspart ([95% CI] -0.59 [-1.09;
-0.09] mmol/L)2 which was a secondary supportive
endpoint.
"For people living with type 1 and type 2 diabetes, it is often
challenging to control blood glucose levels around mealtimes,
resulting in post-meal hyperglycemia," said Dr. Rémi Rabasa-Lhoret,
endocrinologist at the Institut de Recherches Cliniques de Montréal
and onset® investigator. "The data from the
onset® 1 and 2 trials are encouraging as they show some
improvement in HbA1c and even greater improvement in
postprandial glucose control with faster-acting insulin
aspart."
As with other insulin, the most commonly reported adverse event
with faster-acting insulin aspart in onset® 1 and 2 was
hypoglycemia. There were no significant differences in the overall
rate of severe or confirmed hypoglycemia in people with type 1 and
type 2 diabetes compared with
NovoRapid®.1,2
Other common adverse events (≥5%) included nasopharyngitis,
upper respiratory tract infection, urinary tract infection,
headache, nausea, diarrhea, wrong drug administration and back
pain.3,4
Also presented during the scientific meeting were additional
trial results assessing the pharmacokinetic (PK) and
pharmacodynamic (PD) properties of faster-acting insulin aspart
versus NovoRapid®:
- Results from a pooled analysis evaluating early exposure and
glucose-lowering effect of faster-acting insulin aspart versus
NovoRapid® in people with type 1 diabetes (Abstract
929-P).5
- Results from a clinical study evaluating the early
glucose-lowering effect with faster-acting insulin aspart (Abstract
969-P).6
About the onset® 1 and onset® 2
trials
The onset® program is a phase 3 clinical
program with faster-acting insulin aspart that consists of four
trials encompassing more than 2,100 people with type 1 and type 2
diabetes.
The onset® 1 trial (1,143 people randomized): a
26+26-week randomized, partially double-blind, basal-bolus,
treat-to-target trial investigating faster-acting insulin aspart
dosed at mealtime or 20 minutes after starting a meal compared with
NovoRapid® dosed at mealtime, both in combination with a
basal insulin in adults with type 1 diabetes. Only the data from
the first 26 weeks were reported at the 76th annual
Scientific Sessions of the ADA.
The primary endpoint was change from baseline HbA1c
versus NovoRapid®, and a secondary endpoint was change
from baseline in two-hour PPG increment[‡] versus
NovoRapid®.
The onset® 2 trial (689 people randomized): a 26-week
randomized, double-blind, basal-bolus, treat-to-target trial
investigating faster-acting insulin aspart compared with
NovoRapid®, both dosed at mealtime and in combination
with a basal insulin and metformin in adults with type 2 diabetes.
The primary endpoint was change from baseline HbA1c
versus NovoRapid®, and a secondary endpoint was change
from baseline in two-hour PPG increment* versus
NovoRapid®.
About faster-acting insulin aspart
Faster-acting
insulin aspart is an investigational mealtime (bolus) insulin that
is not approved for use in Canada.
It was developed by Novo Nordisk for improved blood glucose control
in adults with type 1 and type 2 diabetes. Faster-acting insulin
aspart is insulin aspart (NovoRapid®) in a new
formulation in which two excipients have been added, a vitamin and
an amino acid, to increase the initial absorption rate and foster
an earlier blood glucose lowering effect.
About NovoRapid® (insulin
aspart)
NovoRapid®
is a man-made insulin used to control high blood sugar in adults
and children with diabetes mellitus.
About Novo Nordisk Canada
Novo Nordisk Canada is an
affiliate of Novo Nordisk A/S, 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:
hemophilia, growth disorders and obesity. Headquartered in
Denmark, Novo Nordisk employs
approximately 40,300 employees in 75 countries, and markets its
products in more than 180 countries.
Novo Nordisk's company history has deep Canadian roots, with
company founders Marie and August
Krogh traveling to Toronto
in 1922 to meet with Banting, Best, Collip and MacLeod to discuss
the insulin preparation. Novo Nordisk would become the first
company in Europe to produce
insulin in 1923.
References
- Russell-Jones D, et al. Double-blind mealtime
faster-acting insulin aspart vs insulin aspart in basal-bolus
improves glycemic control in T1D: the onset® 1 trial.
Oral presentation at: 76th Scientific Sessions of the
American Diabetes Association (ADA). June 10-14,
2016; New Orleans, US.
- Bowering K, et al. Faster-acting insulin aspart vs
insulin aspart as part of basal-bolus therapy improves postprandial
glycemic control in uncontrolled T2D in the double-blinded
onset® 2 trial. Oral presentation at: 76th
Scientific Sessions of the American Diabetes Association
(ADA). June
10-14, 2016; New Orleans,
US.
- Data on file. Novo Nordisk A/S; Bagsværd.
- Data on file. Novo Nordisk A/S; Bagsværd.
- Heise T, et al. Faster onset and greater early exposure
and glucose-lowering effect with faster-acting insulin aspart vs
insulin aspart: a pooled analysis in subjects with type 1 diabetes.
Poster presented at: 76th Scientific Sessions of the
American Diabetes Association (ADA). June 10-14,
2016: New Orleans, US.
- Nosek L, et al. Greater early glucose-lowering effect of
faster-acting insulin aspart is observed consistently from day to
day. Poster presented at: 76th Scientific Sessions of
the American Diabetes Association (ADA). June 10-14,
2016: New Orleans, US.
___________________________________
[*] Postprandial glucose (PPG) increment is the increase in blood
glucose levels after eating
[†] Postprandial glucose (PPG) increment is the increase in blood
glucose levels after eating
[‡] Postprandial glucose (PPG) increment is the increase in blood
glucose levels after eating
SOURCE Novo Nordisk Canada Inc.