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40
VOLUME 9 NUMBER 1 • MARCH 2012
REPORT
SA JOURNAL OF DIABETES & VASCULAR DISEASE
In an evaluation of the factors influenc-
•
ing early insulin initiation, a deteriora-
tion of HbA
1c
levels of 1% increased
the probability of early insulin use by
6%. Higher baseline postprandial glu-
cose (PPG) levels also predicted earlier
insulin use, but higher baseline fasting
plasma glucose (FPG) levels had the
opposite effect.
Interestingly and perhaps a reflection
•
of inappropriate care, the presence of
micro- or macrovascular complications
did not favour the introduction of insu-
lin.
The negative association with higher
•
FPG levels and positive association with
raised BMIs require further explana-
tion.
Optimisation of insulin therapy in
•
patients on basal insulin was, for the
most part, with premix insulin, rather
than switching to a multiple-injection
regimen.
In the real-life clinical setting, switch-
•
ing from biphasic human insulin (BHI)
to biphasic insulin aspart 30 (BIAsp 30)
allowed patients to significantly lower
their HbA
1c
levels and enabled more
patients to achieve HbA
1c
values less
than 7% without increasing the risk of
hypoglycaemia.
Adding mealtime insulin (insulin aspart)
•
is usually an opportunity for markedly
improving the health of people with
type 2 diabetes who are already on
basal insulin.
Results in this real-life clinical situation
•
suggest that when transferring from
insulin glargine with or without oral
glucose-lowering agents, use of insu-
lin detemir may offer the opportunity
to improve glucose control with fewer
major, minor and nocturnal hypogly-
caemic events.
LATE-BREAKING CLINICAL TRIALS
Data show insulin degludec/insulin
aspart combination significantly
reduced hypoglycaemia in type 1
and 2 diabetes patients
A soluble co-formulation of insulin deglu-
dec and insulin aspart (IDegAsp) was
associated with a 58% lower rate of
confirmed hypoglycaemic episodes in
people with type 2 diabetes compared
to biphasic insulin aspart 30 (BIAsp 30),
when dosed twice daily.
1
The unique way
in which insulin degludec/insulin aspart
works, with the basal insulin component
providing an ultra-long and steady action
profile, plus a bolus boost of insulin aspart,
provides a simple way to introduce meal-
time dosing at any meal.
In this phase 2 study, the overall occur-
rence of confirmed hypoglycaemia was
lower with IDegAsp than with BIAsp 30
during the day as well as at night (noctur-
nal events, occurring between midnight
and 06:00). Improvements in FPG were also
seen, with levels significantly lower in the
IDegAsp group than the BIAsp 30 group
(6.4 vs 7.5 mmol/l). The study also found
that IDegAsp was well tolerated and pro-
vided comparable overall glycaemic control
to BIAsp 30 (mean HbA
1c
at week 16: 6.7
vs 6.7%).
1
‘The unique way in which IDegAsp
works, with the basal insulin component
providing an ultra-long and steady action
profile, plus a bolus boost of insulin aspart,
provides a simpleway to introducemealtime
dosing at any meal’, said Dr Alan Moses,
corporate vice president and chief medical
officer of Novo Nordisk. ‘These benefits,
along with the lower risk of hypoglycaemia
and improved FPG shown in these studies,
are very promising for people living with
type 2 diabetes.’
In addition, a phase 3 study, also pre-
sented, showed that rates of hypogly-
caemia at night were lowered by 37% in
people with type 1 diabetes using once-
daily IDegAsp at any meal (with additional
insulin aspart doses for the remaining
meals), compared to those using insulin
detemir once daily plus insulin aspart at all
main meals.
2
IDegAsp, in development by Novo
Nordisk, will, pending approval, be the
only soluble insulin combination of ultra-
long-acting basal insulin degludec and
rapid-acting insulin, insulin aspart. Clinical
studies have shown it provides an optimal
glycaemic control with significantly less
nocturnal hypoglycaemia compared to
premix insulin.
3
Insulin degludec has a unique, slow rate
of absorption which provides a flat and
stable action profile.
4,5
In several clinical
trials, insulin degludec has demonstrated
effective glycaemic control and improve-
ments in both HbA
1c
and FPG levels.
6-9
It
has also demonstrated a significantly lower
rate of nocturnal hypoglycaemia when
compared to insulin glargine.
6,8
Both insulin degludec and insulin deglu-
dec/insulin aspart were submitted to the
European Medicines Agency (EMA) and the
US Food and Drug Administration (FDA)
earlier this year for regulatory review.
Pooled analysis: fewer major
adverse cardiovascular events in
type 2 diabetes patients treated
with sitagliptin
In a pooled analysis also presented at the
IDF congress, a lower incidence of reported
major cardiovascular events (MACE) was
observed in patients with type 2 diabetes
treated with sitagliptin compared to those
treated with a sulphonylurea (SU).
In this analysis of cardiovascular (CV)
safety data from three previously pub-
lished, randomised, blinded clinical stud-
ies, which included patients with type 2
diabetes who had been randomised to
either sitagliptin 100 mg/day (
n
= 1 226)
or an SU (glipizide or glimepiride,
n
= 1
225) as monotherapy or add-on to met-
formin, there were no reports of a major
adverse CV event (ischaemic events and CV
deaths) in the sitagliptin group, whereas
11 patients in the SU group were reported
to have experienced at least one major
adverse CV event.
‘Although a retrospective, pooled anal-
ysis with distinct limitations, this analysis
shows that patients with type 2 diabetes
treated with sitagliptin had fewer major
adverse cardiovascular events compared to
patients treated with sulphonylureas’, said
Barry J Goldstein, MD, PhD, vice president,
Diabetes and Endocrinology, Merck. ‘These
data are important, but prospective stud-
ies are needed. Results of a previously pub-
lished pooled analysis of 19 clinical trials
to evaluate the safety and tolerability of
sitagliptin did not show an increased risk
of CV events with sitagliptin 100 mg/day
compared to placebo or other medicines.’
Flat and stable blood glucose
lowering shown with once-daily
insulin degludec in both type 1 and
2 diabetes patients
A double-blind, cross-over trial in type 2
diabetes patients has shown that once-
daily insulin degludec has a flat and stable
blood glucose-lowering effect over 24
hours. Dosages of 0.4, 0.6 and 0.8 U/kg
were evaluated at steady state in 49 type 2
diabetes patients.
For all dose levels, mean 24-hour glu-
cose infusion rate (GIR) profiles were flat
and stable, while on ending therapy, con-