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Hospital,
4
Cangzhou People
’
s Hospital,
5
PLA. The Military General
Hospital of Beijing,
6
Central Hospital of Minhang District,
7
The Fifth
Peoples Hospital of Shanghai,
8
Shanghai First People
’
s Hospital,
9
Third Hospital of Hebei Medical University,
10
Novo Nordisk (China)
Pharmaceuticals Co., Ltd,
11
Chinese People
’
s Liberation Army General
Hospital, China
Objective:
To compare the effect of liraglutide and sitagliptin
on
β
-cell function and insulin resistance improvements in
Chinese patients with type 2 diabetes.
Methods:
This is a post-hoc analysis of a randomised
controlled clinical trial conducted from Dec. 2013 to Nov.
2014 (total 26 weeks) in China (LIRA-DPP4 CHINA). Patients
aged 18
–
80 inadequately controlled on metformin monother-
apy (HbA1c 7.0
–
10.0%) were included. Eligible subjects were
randomised 1:1 to liraglutide 1.8 mg or sitagliptin 100 mg.
Blood samples were analysed using an enzymatic assay by
central laboratory during the trial for fasting plasma glucose
(FPG), fasting insulin, fasting C-peptide and fasting pro-
insulin. HOMA-
β
and HOMA-IR were calculated. The differ-
ences of above measurements and indexes between treatment
with liraglutide and sitagliptin were analysed using a mixed
model for repeated measurements (MMRM).
Results:
368 subjects were randomised 1:1 to liraglutide
and sitagliptin, and 1 subject in liraglutide group withdrew
before exposure. The baseline characteristics of the two groups
were comparable. Greater reductions of fasting pro-insulin
(28% vs 15%) and fasting pro-insulin to C-peptide ratio (30% vs
15%) were observed with liraglutide compared to sitagliptin,
with estimated treatment ratios of 0.85 [0.75; 0.97], (p = 0.0182)
and 0.83 [0.75; 0.91], (p = 0.0002), respectively. There were
no statistically significant differences in fasting insulin and
fasting C-peptide between the two groups after 26 weeks
of treatment. Lower FPG was achieved with liraglutide
(6.99 mmol/L) compared to sitagliptin (8.21 mmol/L) with
statistical difference of mean changes from baseline at week
26 (
−
2.39 vs
−
1.17 mmol/L, p < 0.0001). An increase in HOMA-
β
and HOMA-IR driven by the better FPG level was achieved in
both treatment groups but was more pronounced with
liraglutide compared to sitagliptin (HOMA-
β
: 75% vs 34%;
with an estimated treatment ratio of1.30 [1.17; 1.45] (p <
0.0001); HOMA-IR (26% vs 11%; with an estimated treatment
ratio of 0.83 [0.73; 0.94], (p = 0.0037).
Conclusion:
After 26 weeks, liraglutide resulted in significant
improvements in fasting pro-insulin, fasting pro-insulin to C-
peptide ratio, HOMA-
β
and HOMA-IR compared to sitagliptin.
This indicates better improvements in
β
-cell function and
insulin resistance with liraglutide compared to sitagliptin,
both in combination withmetformin, in Chinese patients with
type 2 diabetes.
PD-05
Association between serum somatostatin levels and glucose-
lipid metabolism in the Jino ethnic minority and Han Chinese
population
ShiyunWANG
1
, Rong ZHANG
1
, Shanshan TANG
1
, Feng JIANG
1
,
Cheng HU
1
, Weiping JIA
1
*.
1
Shanghai Diabetes Institute, Shanghai
Key Laboratory of Diabetes Mellitus, Shanghai Clinical Center for
Diabetes, Shanghai Jiao Tong University Affiliated Sixth People
’
s
Hospital, China
Objectives:
Somatostatin has been reported as a kind of
peptide hormone that inhibits the secretion of various blood
glucose-regulating hormones, with its serum levels may be
diverse in different populations. This study aimed to investi-
gate the relationship between serum somatostatin levels and
glucose-lipid metabolism in the Jino ethnic minority and Han
Chinese population of Yunnan Province, southwest China.
Methods:
A total of 224 subjects were recruited, comprising 111
subjects from Jino ethnic minority and 113 subjects from Han
Chinese population. Clinical measurements analysis and
glucose-lipid related metabolic traits were conducted among
them. All subjects were divided into three subgroups according
to blood glucose levels: subjects with abnormal fasting plasma
glucose (FPG) only (n = 38 from Jino, n = 39 from Han), subjects
with abnormal 2-h plasma glucose (2hPG) only (n = 37 from
Jino, n = 37 from Han), and subjects with normal glucose
tolerance (NGT) (n = 36 from Jino, n = 37 from Han). Serum
somatostatin levels were measured via enzyme-linked
immunosorbent assay (ELISA).
Results:
We found significant differences in serum somato-
statin levels between Jino ethnic minority and Han Chinese
population (P < 0.0001). For further analysis, both in subgroups
of abnormal FPG only and abnormal 2hPG only, significant
differences were also identified between these two popula-
tions (P = 0.0194 and 0.0106, respectively). But no significant
differences were detected among these three subgroups in
Jino (P = 0.3153) or Han population (P = 0.2779) independently.
After adjusting for covariates, serum somatostatin level
was independently and significantly associated with FPG
(P = 0.0066), TC (P = 0.0041) and LDL-C (P = 0.0055) in all 224
subjects. This relationship was also revealed in abnormal FPG
subgroup (P = 0.0040, 0.0077 and 0.0161, respectively). However,
none of those correlations were found in Jino ethnic minority
or Han Chinese population group independently.
Conclusion:
Our results suggest that serum somatostatin
levels were associated with glucose-lipid metabolism and
this relationship may be various in different populations.
PD-06
Efficacy and safety of SGLT2 inhibitor ipragliflozin in Japanese
patients with type 2 diabetes
Takashi NOMIYAMA
1
*, Makito TANABE
1
, Kunitaka MURASE
1
,
Ryoko MOTONAGA
1
, Toshihiko YANASE
1
.
1
Fukuoka University,
Japan
Obesity and type 2 diabetes have become worldwide problem
including Asian countries. Recently, average BMI of Japanese
patients with type 2 diabetes reached at 25 kg/m
2
. Accordingly,
we need to control blood glucose level without weight gain,
currently. SGLT2 inhibitor ipragliflozin is newly identified
anti-diabetic agent which reduces blood glucose level by
inhibition of glucose reuptake of SGLT2 in kidney. In the
present study, we examined the efficacy and safety of
ipragliflozin in Japanese patients with type 2 diabetes.
125 Japanese patients with type 2 diabetes were treated with
50mg ipragliflozin for 12 weeks added on existing anti-diabetic
therapy. Average age was 53.9 years old, and average BMI was
29.7 kg/m
2
. HbA1c was significantly decreased from 8.0% to
7.4%. Small but significant reduction of BMI was observed from
29.8 to 29.2 kg/m
2
, suggesting that ipragliflozin decreased
blood glucose level without weight gain. Both systolic, from
132.7 to 128.6 mmHg, and diastolic, 80.5 to 76.3 mmHg, blood
pressure were significantly decreased without change of
antihypertensive drug, probably because of osmotic diuresis
by glucose urea. Interestingly, serum C-peptide level was
significantly decreased from 2.8 to 2.5 ng/mL, suggesting that
ipragliflozin reduced blood glucose level without stimulation
of pancreatic beta cells. Ketone bodies, especially 3-hydroxy
lactate, were slightly increased, but not statistical significant.
Severe adverse effect was not observed during study period.
Main adverse effects relating ipragliflozin treatment were
thirsty (3.2%) and skin eruption (2.4%).
These data suggest that SGLT2 inhibitor ipragliflozin could
control blood glucose level safely and effectively in Japanese
patients with type 2 diabetes. In addition to blood glucose
control, reduction of blood pressure, weight reduction
and pancreatic beta cell protection could be expected for
ipragliflozin.
Poster Presentations / Diabetes Research and Clinical Practice 120S1 (2016) S65
–
S211
S93