Benefit of Early Add-on of Linagliptin to Insulin in Japanese Patients With Type 2 Diabetes Mellitus: Randomized-Controlled Open-Label Trial (TRUST2)

被引：5

作者：

Katsuno, Tomoyuki ^{[1
,2
]}

Shiraiwa, Toshihiko ^{[3
]}

Iwasaki, Shingo ^{[4
]}

Park, Hyohun ^{[5
]}

Watanabe, Nobuaki ^{[6
]}

Kaneko, Shizuka ^{[7
]}

Terasaki, Jungo ^{[8
]}

Hanafusa, Toshiaki ^{[9
]}

Imagawa, Akihisa ^{[8
]}

Shimomura, Iichiro ^{[10
]}

Ikegami, Hiroshi ^{[11
]}

Koyama, Hidenori ^{[1
]}

Namba, Mitsuyoshi ^{[1
,12
]}

Miyagawa, Jun-ichiro ^{[1
,13
]}

机构：

[1] Hyogo Coll Med, Dept Internal Med, Div Diabet Endocrinol & Clin Immunol, Nishinomiya, Hyogo, Japan

[2] Hyogo Univ Hlth Sci, Sch Rehabil, Dept Occupat, Kobe, Hyogo, Japan

[3] Shiraiwa Med Clin, Osaka, Japan

[4] Iwasaki Internal Med Clin, Osaka, Japan

[5] Fukuda Clin, Osaka, Japan

[6] Watanabe Clin, Kobe, Hyogo, Japan

[7] Takatsuki Red Cross Hosp, Osaka, Japan

[8] Osaka Med Coll, Dept Internal Med 1, Takatsuki, Osaka, Japan

[9] Sakai City Med Ctr, Osaka, Japan

[10] Osaka Univ, Grad Sch Med, Dept Metab Med, Osaka, Japan

[11] Kindai Univ, Dept Endocrinol Metab & Diabet, Osaka, Japan

[12] Takarazuka City Hosp, Takarazuka, Hyogo, Japan

[13] Keiseikai Med Corp, Osaka, Japan

来源：

ADVANCES IN THERAPY | 2021年 / 38卷 / 03期

关键词：

DPP-4; inhibitor; Glycemic control; Linagliptin; Insulin; Quality of life; Type 2 diabetes mellitus; DIPEPTIDYL PEPTIDASE-4 INHIBITORS; DOUBLE-BLIND; RENAL IMPAIRMENT; GLYCEMIC CONTROL; DPP-4; INHIBITOR; BASAL INSULIN; SAFETY; SITAGLIPTIN; EFFICACY; THERAPY;

D O I：

10.1007/s12325-021-01631-y

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Introduction This trial was conducted to assess the long-term safety, efficacy, and benefit of early add-on of linagliptin to insulin in patients with type 2 diabetes mellitus (T2DM). Methods This trial enrolled 246 subjects. The subjects were randomized to the linagliptin group or the control group and were observed for 156 weeks. After week 16, subjects in the control group were also allowed to add linagliptin to evaluate the benefit of early add-on of linagliptin to insulin. The primary end point was a change in HbA1c from baseline to week 16. Secondary end points included fasting plasma glucose, daily insulin dose, and frequency of adverse events. Results HbA1c and fasting plasma glucose levels significantly decreased from baseline to week 16 in the linagliptin group compared with the control group. The significant improvement in HbA1c continued until week 52. The daily insulin dose significantly decreased in the linagliptin group compared with the control group. The frequency of hypoglycemia and adverse events was comparable in both groups. Conclusions Add-on of linagliptin to insulin was tolerated, improved glycemic control, and reduced the daily insulin dose. This study demonstrates the long-term safety, efficacy and benefit of early add-on of linagliptin to insulin in Japanese T2DM patients.

引用

页码：1514 / 1535

页数：22

共 36 条

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