Diabetes Research and Clinical Practice - Volume 120 - Supplement 1 - October 2016

133 / 244

T2D is an epidemic disease in Asia, with younger age and
lower BMI at diagnosis in Asian vs non-Asian patients. This
subject-level analysis compared clinical outcomes in Asian
and non-Asian patients with T2D from 16 RCTs (target FPG
≤ 100 mg/dL,≥ 24-week duration) adding insulin glargine 100 U/
mL (Gla-100) to OADs. Data were compared overall and by
concomitant OAD therapy at baseline and Week 24. Of 3,586
participants, 235 were Asian. Patients received either metfor-
min (MET) (n = 76), MET plus sulfonylurea (SU) (n = 111), SU
(n = 16) or other OADs (n = 32).
At baseline, compared with non-Asian patients, Asians were
younger (53.7 vs 57.9 years; P < 0.001), had lower BMI (27.1 vs
30.8 kg/m 2; P < 0.001) and FPG (169 vs 194 mg/dL; P < 0.001), but
had similar diabetes duration (8.9 years) and HbA1c (8.6% vs
8.7%; P = 0.08). Mean baseline fasting C-peptide was available
for 104 (44%) Asian and 2,082 (62%) non-Asian patients and
was lower for Asian patients (0.95 vs 1.18 nmol/L; P < 0.001).
Pearson correlation indicated a clear association of low C-
peptide level with low BMI in both Asian and Non-Asian
patients (both P < 0.001); this was most prominent in Asian
patients.
After 24 weeks of treatment, Asian patients had a smaller
HbA1c reduction ( −1.30% vs − 1.55%; P < 0.001), a higher overall
endpoint HbA1c (7.42% vs 7.16%; P < 0.001), and a lower
proportion of Asian patients achieved HbA1c ≤7.0% (40% vs
47%; P = 0.002). FPG reductions were similar in Asian and non-
Asian patients (− 78 vs −75 mg/dL; P = 0.27) with numerically
more Asian patients reaching FPG ≤ 100 mg/dL (48% vs 34%;
P = 0.21). Final daily insulin dose (0.47 vs 0.45 U/kg; P = 0.16) and
hypoglycemia incidences (45% vs 47%) and event rates (5.3 vs
5.7 episodes/patient-year, PG < 70 mg/dL) were comparable
in Asian and non-Asian patients. Asian patients had less
weight gain (1.3 vs 1.9 kg; P = 0.01). Parameters of glycemic
control and weight changewere consistentlymore favorable in
the Gla-100 + MET vs Gla-100 + MET + SU treated group, with
similar estimated treatment differences between Asian vs
non-Asian patients, as observed in the overall treatment
groups. However, final insulin doses were higher in the Gla-
100 + MET group for Asians (0.57 U/kg) and non-Asians (0.50 U/
kg; P = 0.040 between groups) compared with corresponding
MET + SU subgroups (Asian: 0.36 U/kg vs non-Asian: 0.41 U/kg;
P = 0.045).
At similar Gla-100 doses and hypoglycemia risk, overall
glycemic control was worse in Asian than in non-Asian
patients, suggesting higher daily insulin doses or additional
antidiabetes drugs are needed for adequate glycemic control.
PD-76
A reduced risk of hypoglycaemia with insulin degludec vs.
insulin glargine U100 in Asian insulin-naïve patients with T2D
Wenying YANG 1, Qiang LI2, Zhengfang LI3, Jin-Kui YANG 4,
Shandong YE 5*, Charlotte HANSEN 6, Hongfei XU7,
Changyu PAN 8. 1China-Japan Friendship Hospital, Beijing, 2The
Second Affiliated Hospital of Harbin Medical University, Harbin, 3The
Second Affiliated Hospital of Kunming Medical University, Kunming,
4 Beijing Tongren Hospital, Capital Medical University, Beijing,
5 Anhui Provincial Hospital, Anhui, China; 6Novo Nordisk A/S,
Søborg, Denmark; 7Novo Nordisk Pharmaceuticals, 8Chinese PLA
General Hospital, Beijing, China
Background and aims: Insulin degludec (IDeg) is a basal insulin
with a long and stable glucose-lowering effect with lowwithin-
patient variability. A previous, global, pre-planned patient-
level meta-analysis of phase 3a trials showed IDeg was
associated with significantly lower rates of overall confirmed,
nocturnal confirmed, and severe hypoglycaemia vs. insulin
glargine U100 (IGlar U100) in insulin-naïve patients with type 2
diabetes (T2D). This pan-Asian post-hoc meta-analysis com-
pared the rates of hypoglycaemia with IDeg and IGlar U100 in
Asian insulin-naïve patients with T2D.
Methods:This Asian patient-level meta-analysis included two
26-week open-label, phase 3a, randomised, treat-to-target
trials; BEGIN ONCE ASIA, and the China cohort of BEGIN
ONCE representing all insulin-naïve Asian participants of
the IDeg phase 3a clinical trial programmewith T2D (excluding
the BEGIN Flex trials). Both compared once-daily (OD)
IDeg (n = 662 [BEGIN ONCE ASIA, n = 289; BEGIN ONCE-China
cohort, n = 373]) and OD IGlar U100 (n = 333 [BEGIN ONCE
ASIA, n = 146; BEGIN ONCE-China cohort, n = 187]). Trial
maintenance period was defined as after 16 weeks of
treatment. Confirmed hypoglycaemia was defined as severe
episodes (requiring assistance), or plasma glucose confirmed
<3.1 mmol/L. Nocturnal confirmed hypoglycaemia included
confirmed episodes with onset between 00.01 and 05.59, both
inclusive.
Results: Similar glycaemic control was achieved at end-of-
trial; IDeg was non-inferior to IGlar in terms of HbA1c
reduction in the individual trial populations, with end-of-
trial means of 7.2% and 7.1% respectively (BEGIN ONCE ASIA)
and 6.9% and 7.0% respectively (BEGIN ONCE-China cohort).
Compared with IGlar U100, treatment with IDeg resulted in
a significant 24% lower rate of confirmed hypoglycaemic
episodes during the total trial period (rate ratio (RR) 0.76
[0.59; 0.97]95% CI), increasing to a 30% lower rate during the
maintenance period (RR 0.70 [0.50; 0.99] 95% CI). Furthermore,
there was a significant 43% lower rate of nocturnal confir-
med hypoglycaemic episodes with IDeg during the total trial
period (RR 0.57 [0.37; 0.87] 95% CI) and a numerically 41%
lower rate during the maintenance period (RR 0.59 [0.32; 1.08]
95% CI) compared with IGlar. Only two episodes of severe
hypoglycaemia occurred (both with IGlar U100), hence no
statistical analysis was performed.
Conclusion: In Asian insulin-naïve patients with T2D, IDeg OD
had significant hypoglycaemia benefits compared with IGlar
U100, consistent with the findings of the global pre-planned
meta-analysis. Clinically relevant reductions in both overall
confirmed and nocturnal confirmed hypoglycaemia could lead
to further improvement in the treatment of T2D.
PD-77
Sequential changes in clinical findings of diabetic patients by
replacing insulin glargine with degludec
Yoshiro KATO1*, Hideki KAMIYA1, Shin TSUNEKAWA1,
Masaki KONDO1, Tatsuhito HIMENO1, Yuichiro YAMADA1,
Toshihito ANDO1, Saeko ASANO1, Hiromi SHIMODA1,
Koichi KATO2, Jiro NAKAMURA1. 1Division of Diabetes,
Department of Internal Medicine, Aichi Medical University School of
Medicine, 2Laboratory of Medicine, Aichi Gakuin University School of
Pharmacy, Japan
Background: Insulin degludec (Deg) has the different
characteristics from those of insulin glargine (Gla). However,
the changes in clinical findings of patients by replacing Gla
with Deg has been rarely investigated by using continuous
glucose monitoring (CGM).
Purpose: This study was aimed at investigating how the
replacement of Gla with Deg affects the clinical findings of
diabetic patients by CGM.
Methods: A total of 26 diabetic outpatients enrolled in this
study comprised 17 type 1 diabetic patients (male/female: 4/13,
age: 53.9 ± 14.2 years, HbA1c: 7.7 ± 0.9%) and 9 type 2 diabetic
patients (male/female: 6/3, age: 64.9 ± 7.4 years, HbA1c:
7.3 ± 0.6%). In 17 type 1 diabetic patients, Gla was given twice
a day in 14 patients and once a day in 3 patients. In 9 type 2
diabetic patients, 7 received intensive insulin therapy and 2
were given basal insulin therapy. After replacing Gla with Deg
administered once a day, the mean and standard deviation
(SD) of blood glucose levels (BG), frequency of hypoglycemia
(<70 mg/dL) for a day and at night (0–6 a.m.) were sequentially
measured by CGM.
Poster Presentations / Diabetes Research and Clinical Practice 120S1 (2016) S65–S211 S115