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

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Background: Semaglutide is a glucagon-like peptide (GLP)-1
analog with an extended half-life in phase 3 development
for type 2 diabetes (T2D). This study evaluated the effect of
once-weekly subcutaneous (s.c.) semaglutide in steady state
versus placebo on beta-cell responsiveness in subjects with
T2D.
Methods: In this double-blind, parallel-group trial, 75 adults
with T2D (mean HbA1c 7.3%, duration of T2D 8.5 years, body
mass index (BMI) 29.6 kg/m2, age 56 years, 68% male) were
randomised 1:1 to once-weekly s.c. semaglutide (escalated to
1.0 mg) or placebo for 12 weeks. Intravenous glucose tolerance
tests (IVGTT; 25 g glucose bolus), arginine stimulation tests (5 g
arginine 2 hours after glucose infusion) and graded glucose
infusion (GGI) tests (target glucose levels: 5, 6, 7, 8, 9, 10, 11 and
12 mmol/L over 180 min) were performed at baseline and at
week 12. A control group of 12 untreated healthy subjects
(mean BMI 26.8 kg/m 2, age 43 years, 67%male) also underwent
a GGI test. Insulin response was measured as the semaglutide:
placebo ratio for changes from baseline to end-of-treatment in
the area under the curve. The primary endpoint was first- (0 –
10 min) and second- (10–120 min) phase insulin secretion in
the IVGTT.
Results: Following IVGTT, change from baseline for both
first- and second-phase insulin responses in subjects receiv-
ing semaglutide was significantly greater than in those
receiving placebo (estimated treatment ratio [ETR] 3.02 [95%
CI: 2.53 –3.60] and 2.10 [95%CI: 1.86–2.37], respectively). In the
arginine stimulation test, increases from baseline for both
insulin concentrations and insulin secretion rate in subjects
receiving semaglutide were significantly greater than for
those receiving placebo during 0–10 min (ETR 2.82 [95%CI:
2.39; 3.32] and 1.69 [95%CI: 1.49; 1.92], respectively) and
0 – 30 min (ETR 4.42 [95%CI: 3.74; 5.22] and 2.69 [95%CI: 2.38;
3.05], respectively).
In the GGI test, the insulin secretion rate and slope at end of
treatment were significantly greater for semaglutide than
placebo. In the semaglutide group, both parameters were
comparable to those of untreated healthy subjects.
No new safety or tolerability issues were identified for
semaglutide.
Conclusion: Semaglutide (1.0 mg s.c. once weekly) signicantly
improved first- and second-phase insulin secretion compared
with placebo after 12 weeks of treatment. Beta-cell respon-
siveness at the end of the study in the semaglutide group
was comparable to that of untreated healthy individuals.
Semaglutide was well tolerated, with a safety profile similar to
that of other GLP-1 receptor agonists.
PD-117
Comparison of the efficacy and safety of insulin degludec
between type 1 and type 2 diabetes
Atsushi FUJIYA 1*, Risa SHIMAUCHI 1, Makoto KATO1,
Emiri MIURA 1, Taiga SHIBATA1 , Hiroshi SOBAJIMA1. 1Ogaki
Municipal Hospital, Japan
Background: Novel insulin degludec (IDeg), a long-acting basal
insulin analog extending more than 24 hours, improves
glycemic control without an increasing risk of hypoglycemia
in both type 1 (T1DM) and type 2 diabetes mellitus (T2DM).
The aim of this study is to evaluate the efficacy and safety of
between T1DM and T2DM in daily practice.
Methods: Between March 2013 and March 2016, consecutive
283 DM patients who have received IDeg once a day were
enrolled in this study. Of them, patients who were being
treated with IDeg for more than 52 weeks after switching their
basal insulin to IDeg were examined. Insulin dose and other
medications were adjusted at their discretions in routine
clinical practice. In order to evaluate the efficacy of IDeg,
transition of glycated hemoglobin (HbA1c) level, BMI were
evaluated in both groups. Daily total insulin dose, and basal
insulin dose, and the frequency of hypoglycemic attack were
examined in T1DM group who have been received inten-
sive insulin therapy and SMBG to evaluate the safety of
IDeg. These data was evaluated before and after 4, 8, 12, 24
and 52 weeks starting IDeg. Furthermore, frequent hypo-
glycemia was defined as hypoglycemic attack more than once
a week.
Results: Data was available in a total of 148 patients (T1DM; 97
patients and T2DM; 51 patients). HbA1c level (%) was
significantly improved at 52 weeks in patients with T1DM
(8.4 ± 1.5 vs. 7.8 ± 1.3, p = 0.048) and in those with T2DM
(7.8 ± 1.1 vs. 7.2 ± 0.8, p < 0.001). There is no difference in BMI
between at baseline and at 52 week in the 2 groups. In the
T1DM group, daily total insulin dose and basal dose (unit/kg/
day) were significantly decreased [0.63 ± 0.20 vs. 0.60 ± 0.22
(p = 0.0012) and 0.24 ± 0.10 vs. 0.22 ± 0.10 (p = 0.0057), respect-
ively]. In the T1DM group, the frequency of hypoglycemic
attack more than once a week was improved after switching
their basal insulin to IDeg.
Conclusion: IDeg could improve glycemic control for patients
with both T1DM and T2DM without an increasing risk of
hypoglycemia.
PD-118
Long-term glucose lowering effects of sitagliptinmonotherapy
and dietary contents in Japanese individuals with type 2
diabetes
Saki OKAMOTO1, Hitoshi KUWATA1,2, Daisuke YABE1–3*,
Yoshiyuki HAMAMOTO1,2, Takeshi KUROSE1,2,
Yutaka SEINO1,2. 1Center for Diabetes, Endocrinology and
Metabolism, Kansai Electric Power Hospital, 2Yutaka Seino
Distinguished Center for Diabetes Reseach, Kansai Electric Power
Medical Research Institute, 3Center for Metabolism and Clinical
Nutrition, Kansai Electric Power Hospital, Japan
Aims: This study was designed to assess possible relationship
of long-term glucose-lowering effects of dipeptidyl-peptidase
4 inhibitor sitagliptin with intake of macro-nutrients in
Japanese individuals with type 2 diabetes.
Materials and methods: Changes in bodyweight (BW) and
hemoglobin A1c (HbA1c) as well as estimated intake of macro-
nutrients were retrospectively obtained for 54 Japanese
individuals with type 2 diabetes who initiated and continued
sitagliptin monotherapy without any prescription change
for 48 week (wk). Patients were categorized into two groups:
Group A, ΔHbA1c (48 wk – 24 wk) ≥0.4% and Group B, ΔHbA1c
(48 wk – 24 wk) <0.4%. Self-administered 3-day food records
were analyzed for estimated intake of macro-nutrients using
Healthy Maker Pro (Mushroomsoft Co., Ltd., Japan)
Results: Group A (n = 8; age 61.3 ± 9.3 years) showed increase in
BW (kg; 70.6 ± 6.2 to 71.7 ± 6.1) and HbA1c (%; 6.6 ± 0.3 to
7.3 ± 0.4) between 24 and 48 wks. In contrast, Group B (n = 44;
age 62.7 ± 8.5 years) showed little change in BW (kg; 62.5 ± 4.8 to
62.1 ± 5.2) and HbA1c (%; 6.5 ± 0.5 to 6.5 ± 0.5). Changes in BW
differ significantly between the two groups. Total energy
intake was significantly greater in Group A (32.8 ± 4.9 kcal/kg
IBW/day) than that of Group B (28.5 ± 5.9 kcal/kg IBW/day).
Interestingly, fat intake was significantly greater in Group A
(1.08 ± 0.15 g/kg IBW/day) than that of Group B (0.86 ± 0.26 g/kg
IBW/day) while carbohydrate intake (Group A, 3.87 ± 0.88 g/kg
IBW/day; Group B, 3.66 ± 0.81 g/IBW) and protein intake (Group
A, 1.32 ± 0.23 g/kg IBW/day; Group B, 1.16 ± 0.26 g/IBW) did not
differ between the two groups.
Conclusion: Among patients receiving sitagliptin mono-
therapy for 48 wk, those who consumed more fats resulted
in deterioration of HbA1c-lowering effects, suggesting that
dairy diets play a critical role in maintaining long-term
glucose-lowering effects of dipeptidyl-peptidase-4 inhibitors.
Poster Presentations / Diabetes Research and Clinical Practice 120S1 (2016) S65–S211 S128