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

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Gemigliptin is a potent, selective, competitive, and long-acting
dipeptidyl peptidase (DPP) -4 inhibitor. This study evaluated
the efficacy and safety of gemigliptin as add-on therapy to
metformin and glimepiride for 24 weeks compared with
placebo in patients with type 2 diabetes mellitus (T2DM)
inadequate glycemic control.
In this multicenter, randomized, double-blind, Phase III
study, eligible patients with inadequate glycemic control
(7% HbA1c ≤ 11%) were randomized to gemigliptin 50 mg
q.d (n = 109) or placebo (n = 110). The primary endpoint was
change from baseline in HbA1c after 24 weeks. Baseline
demographics were similar between groups (age 60.9 years;
BMI 24.9 kg/m 2, duration of T2DM 12.9 years), with mean ±SD
baseline HbA1c of 8.12 ± 0.82% in the gemigliptin group and
8.15 ± 0.89% in the placebo group. At Week 24, adjusted
mean ±SE change HbA1c with gemigliptin was −0.88 ± 0.17%
(change with placebo − 0.01 ± 0.18%; difference −0.87 ± 0.12%,
95% CI −1.09 to − 0.64; p < 0.0001). The differences in pro-
portions achieving an HbA1c < 7 or < 6.5% were also statistic-
ally significant (p < 0.0001) between groups. Gemigliptin was
generally well tolerated, although therewas a higher incidence
of overall adverse events (AEs) in the gemigliptin group than
in the placebo group (56.1% and 36.0%, respectively). Drug-
related AEs were reported for 3.7% and 2.7% of gemigliptin and
placebo, respectively. Hypoglycemia occurred in 9.4 and 2.7%
of the gemigliptin and placebo groups, respectively.
In conclusion, triple therapy with gemigliptin 50 mg q.d in
patients with T2DM inadequately controlled on metformin
and glimepiride improved glycemic control and was generally
well tolerated over 24weeks.
PD-110
Efficacy and safety of gemigliptin in type 2 diabetes patients
with moderate to severe renal impairment
Sun Ae YOON 1, Byoung Geun HAN2, Sung Gyun KIM3,
Sang Youb HAN 4, Young-Il JO5 , Kyung Hwan JEONG6,
Kook-Hwan OH 7, Hyoungchun PARK8, Sun-Hee PARK9,
Shin-Wook KANG 10, Ki-Ryang NA 11, Sun Woo KANG12,
Nam-Ho KIM 13, YoungHwan JANG14, Sung-Ho KIM14,
Dae Ryong CHA 15*. 1Uijeongbu St. Mary’s Hospital, 2Yonsei
University Wonju College of Medicine, 3Hallym University Sacred
Heart Hospital, 4Ilsan Paik Hospital, 5Konkuk University School of
Medicine, 6Kyung Hee University School of Medicine, 7Seoul National
University College of Medicine, 8Gangnam Severance Hospital,
9 Kyungpook National University School of Medicine, 10Yonsei
University College of Medicine, 11Chungnam National University
College of Medicine, 12Busan Paik Hospital, 13Chonnam National
University Medical School, 14LG Life Sciences, 15Korea University
Ansan-Hospital, Korea
Renal impairment in type 2 diabetesmellitus (T2DM) limits the
available glucose-lowering medication and requires frequent
monitoring of renal function. Gemigliptin has balanced
elimination between urinary/fecal excretion and hepatic
metabolism. Thus, it needs no dose adjustment in patient
with moderate to severe renal impairment. This study
evaluated the efficacy and safety of gemigliptin in type 2
diabetic patients with moderate to severe renal impairment.
This randomized, double blind, parallel group Phase 3b study
comprised a 12-week, placebo-controlled phase followed by a
40-week, double blind active-controlled extension phase.
Patients (mean HbA1c 8.4%; age 62.0 years; BMI 26.2 kg/m 2,
duration of T2DM 16.3 years; eGFR 33.3 mL/min/1.73 m 2)
treated with gemigliptin (n = 66) or placebo (n = 66) for 12
weeks, then placebo groupwas switched to linagliptin 5 mg q.d
and treatment continued to Week 52. Primary endpoint was
HbA1c change from baseline at Week 12.
At Week 12, adjusted mean ±SE change HbA1c with gemig-
liptin was −0.83 ± 0.14% (change with placebo 0.38 ± 0.14%;
difference −1.21, 95% CI − 1.54 to −0.89; p < 0.0001). After 52
weeks, adjusted mean ± SE change from baseline in HbA1c
was −1.00 ± 0.21% and −0.65 ± 0.22% in the gemigliptin and
linagliptin groups, respectively. Urinary albumin creatinine
ratio (UACR) at week 12 was reduced by 28.0% (95%CI −40.2 to
−13.3) with gemigliptin compared with 4.3% (95%CI −19.7 to
14.2) with placebo, with a between-group difference of 24.8%
(95%CI −41.8 to −2.9; p = 0.0294). During the 40-week extension,
adverse events (AEs) were reported in 68.0% and 73.1% of
subjects on gemigliptin and linagliptin, respectively. The
incidence of hypoglycemia was similar among treatment
groups (gemigliptin, 20.0%; linagliptin, 28.8%). There was no
meaningful change from baseline in body weight (gemigliptin,
0.28 kg; linagliptin 0.33 kg).
In conclusion, gemigliptinwas efficacious andwell tolerated in
T2DM patients with moderate to severe renal impairment.
PD-112
Current status of metformin or acabose in addition to insulin
therapy in adult patients with T1DM in Guangdong, China
Liling QIU1, Jinhua YAN1, Daizhi YANG1, Sihui LUO1,
Xueying ZHENG1, Wenqian REN1, Shanshan XIONG1, Bin YAO1,
Jianping WENG1*. 1Department of Endocrinology and Metabolic
Disease, The Third Affiliated Hospital of Sun Yat-sen University,
Guangdong Provincial Key Laboratory of Diabetology, China
It was shown in some previous studies that metformin or
α-glucosidase inhibitors in combination with insulin con-
tributed to improving the glycemic control in patients with
type 1 diabetes (T1D), but the benefits of these agents for
T1D were still suspensive. We use data from the Guangdong
T1DM Translational Medicine Study to describe the current
use and efficacy of additional metformin or acabose therapy
in T1D.
Patients aged ≥18 years with T1D were included from the
Guangdong T1DM Translational Medicine Study, which was a
multicenter registry study of T1D in Guangdong, China.
Patients treated with additional metformin (Metformin
group, n = 90) or additional acabose (Acabose group, n = 63)
added to insulin therapy were compared against those with
insulin therapy only (Insulin group, n = 897).
Patients took 1000 mg of metformin or 120 mg of acabose per
day on average. At baseline, the body mass index (BMI) of
patients in the Metformin group (22.5 ± 3.9 kg/m2) was higher
than that of Acabose group (20.7 ± 2.8 kg/m2) or Insulin group
(20.3 ± 2.8 kg/m2) (p < 0.001), while patients in Acabose group
(38.9 ± 12.7 years old) were older than those in Metformin
group (31.4 ± 12.8 years old) or Insulin group (33.2 ± 11.8 years
old) (p < 0.001). But gender distribution, duration of diabetes,
HbA1c, daily insulin dosage and waist-hip ratio (WHR) had no
statistical difference between groups. After 1-year’s follow-
up, HbA1c improved in all groups, but the changes of it were
not significantly different between groups (Metformin group,
−0.7 (−1.7, 0.2) % vs. Acabose group, −0.4 ( −2.1, 0.4) % vs.
Insulin group, −0.4 (−1.6, 0.4) %, p = 0.513). While the daily
insulin dosage, WHR and the frequency of hypoglycemia
episodes did not change in all groups. Addition of metformin
resulted in an unchanged BMI, while patients experienced
weight gain with BMI increasing by 0.5 ± 1.3 kg/m2 in Acabose
group (p = 0.038) and 0.6 ± 2.2 kg/m2 in Insulin group
(p < 0.001).
The results suggested that metformin is initiated more in type
1 diabetic patients with higher BMI while acabose is initiated
more in older patients with T1D in current practice in China.
Additional metformin or acabose therapy does not improve
the glycemic control for patients with T1D but additional
metforminmay contributes to keeping weight. Further study is
necessary to explore their efficacy and safety in type 1 diabetic
patients.
Poster Presentations / Diabetes Research and Clinical Practice 120S1 (2016) S65–S211 S126