diabetes research and clinical practice 103 (2014) e30–e33
Contents available at ScienceDirect
Diabetes Research and Clinical Practice jou rnal hom ep ag e: w ww.e l s e v i er . c om/ loca te / d i ab r es
Brief report
Safety and efficacy of adding sitagliptin to insulin in patients with type 2 diabetes: The ASSIST-K study Masahiko Takai a, Masashi Ishikawa a, Hajime Maeda a, Akira Kanamori a, Akira Kubota a, Hikaru Amemiya a, Takashi Iizuka a, Kotaro Iemitsu a, Tomoyuki Iwasaki a, Goro Uehara a, Shinichi Umezawa a, Mitsuo Obana a, Hideaki Kaneshige a, Mizuki Kaneshiro a, Takehiro Kawata a, Nobuo Sasai a, Tatsuya Saito a, Tetsuo Takuma a, Hiroshi Takeda a, Keiji Tanaka a, Nobuaki Tsurui a, Shigeru Nakajima a, Kazuhiko Hoshino a, Shin Honda a, Hideo Machimura a, Kiyokazu Matoba a, Fuyuki Minagawa a, Nobuaki Minami a, Yukiko Miyairi a, Atsuko Mokubo a, Tetsuya Motomiya a, Manabu Waseda a, Masaaki Miyakawa a, Yoshikazu Naka a, Yasuo Terauchi b, Yasushi Tanaka c, Ikuro Matsuba a,* a
The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan Department of Endocrinology and Metabolism, Yokohama City University, Kanagawa, Japan c Department of Internal Medicine, Division of Metabolism and Endocrinology, St. Marianna University School of Medicine, Kanagawa, Japan b
article info
abstract
Article history:
We retrospectively studied more than 1000 patients with type 2 diabetes attending 36
Received 6 September 2013
Japanese clinics to investigate the efficacy and safety of adding sitagliptin to various insulin
Received in revised form
regimens. We found that the treatment with add-on sitagliptin for 6-months was effective,
6 September 2013
irrespective of the type or dose of concomitant insulin.
Accepted 26 December 2013
# 2014 Elsevier Ireland Ltd. All rights reserved.
Available online 6 January 2014 Keywords: Type 2 diabetes Sitagliptin Insulin Glycemic control
* Corresponding author at: Matsuba Medical Clinic, 2-159 Tsukagoshi, Saiwai-ward, Kawasaki-city, Kanagawa 212-0024, Japan. Tel.: +81 44 522 1678; fax: +81 44 522 1698. E-mail address: [email protected] (I. Matsuba). 0168-8227/$ – see front matter # 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.diabres.2013.12.045
e31
diabetes research and clinical practice 103 (2014) e30–e33
1.
Introduction
3.
Although patients with type 2 diabetes mellitus (T2DM) receiving insulin therapy usually have a long duration of disease and a reduced insulin secretory capacity, their characteristics vary. In the real clinical setting, a variety of insulin regimens are employed to treat T2DM along with the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin. However, there have been few reports on the usefulness of such strategies [1–4], and studies need to be done to investigate the safety and efficacy of combined treatment with sitagliptin and various insulin regimens in a large patient population. We addressed these issues by performing a study at 36 diabetes clinics.
2.
Research design and methods
This retrospective multicenter study enrolled outpatients with T2DM who had inadequate glycemic control despite receiving insulin and were treated with add-on sitagliptin therapy from November 2011 to March 2013. Their glycemic control, insulin dose, concomitant drugs, body weight, laboratory parameters, and adverse events were analyzed. All the patients enrolled had received insulin therapy for at least 6 months before starting add-on sitagliptin, had a hemoglobin A1c (HbA1c) 7.0%, and were followed for 6 months after the start of combined treatment. Results are reported as the mean standard deviation. All analyses were performed using SPSS version 19 (SPSS Inc., Chicago, IL, USA). The effect of sitagliptin treatment was assessed by one-way analysis of variance (ANOVA) and statistical significance was accepted at p < 0.05. This study was approved by the Ethics Committee of the Kanagawa Physicians Association, and was registered with the Clinical Trials Registry (http://clinicaltrials.gov; NCT01855087).
Results
A total of 1004 patients were analyzed after excluding 53 patients who received add-on sitagliptin for less than 6 months, 81 patients with an HbA1c
Contents available at ScienceDirect
Diabetes Research and Clinical Practice jou rnal hom ep ag e: w ww.e l s e v i er . c om/ loca te / d i ab r es
Brief report
Safety and efficacy of adding sitagliptin to insulin in patients with type 2 diabetes: The ASSIST-K study Masahiko Takai a, Masashi Ishikawa a, Hajime Maeda a, Akira Kanamori a, Akira Kubota a, Hikaru Amemiya a, Takashi Iizuka a, Kotaro Iemitsu a, Tomoyuki Iwasaki a, Goro Uehara a, Shinichi Umezawa a, Mitsuo Obana a, Hideaki Kaneshige a, Mizuki Kaneshiro a, Takehiro Kawata a, Nobuo Sasai a, Tatsuya Saito a, Tetsuo Takuma a, Hiroshi Takeda a, Keiji Tanaka a, Nobuaki Tsurui a, Shigeru Nakajima a, Kazuhiko Hoshino a, Shin Honda a, Hideo Machimura a, Kiyokazu Matoba a, Fuyuki Minagawa a, Nobuaki Minami a, Yukiko Miyairi a, Atsuko Mokubo a, Tetsuya Motomiya a, Manabu Waseda a, Masaaki Miyakawa a, Yoshikazu Naka a, Yasuo Terauchi b, Yasushi Tanaka c, Ikuro Matsuba a,* a
The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Kanagawa, Japan Department of Endocrinology and Metabolism, Yokohama City University, Kanagawa, Japan c Department of Internal Medicine, Division of Metabolism and Endocrinology, St. Marianna University School of Medicine, Kanagawa, Japan b
article info
abstract
Article history:
We retrospectively studied more than 1000 patients with type 2 diabetes attending 36
Received 6 September 2013
Japanese clinics to investigate the efficacy and safety of adding sitagliptin to various insulin
Received in revised form
regimens. We found that the treatment with add-on sitagliptin for 6-months was effective,
6 September 2013
irrespective of the type or dose of concomitant insulin.
Accepted 26 December 2013
# 2014 Elsevier Ireland Ltd. All rights reserved.
Available online 6 January 2014 Keywords: Type 2 diabetes Sitagliptin Insulin Glycemic control
* Corresponding author at: Matsuba Medical Clinic, 2-159 Tsukagoshi, Saiwai-ward, Kawasaki-city, Kanagawa 212-0024, Japan. Tel.: +81 44 522 1678; fax: +81 44 522 1698. E-mail address: [email protected] (I. Matsuba). 0168-8227/$ – see front matter # 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.diabres.2013.12.045
e31
diabetes research and clinical practice 103 (2014) e30–e33
1.
Introduction
3.
Although patients with type 2 diabetes mellitus (T2DM) receiving insulin therapy usually have a long duration of disease and a reduced insulin secretory capacity, their characteristics vary. In the real clinical setting, a variety of insulin regimens are employed to treat T2DM along with the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin. However, there have been few reports on the usefulness of such strategies [1–4], and studies need to be done to investigate the safety and efficacy of combined treatment with sitagliptin and various insulin regimens in a large patient population. We addressed these issues by performing a study at 36 diabetes clinics.
2.
Research design and methods
This retrospective multicenter study enrolled outpatients with T2DM who had inadequate glycemic control despite receiving insulin and were treated with add-on sitagliptin therapy from November 2011 to March 2013. Their glycemic control, insulin dose, concomitant drugs, body weight, laboratory parameters, and adverse events were analyzed. All the patients enrolled had received insulin therapy for at least 6 months before starting add-on sitagliptin, had a hemoglobin A1c (HbA1c) 7.0%, and were followed for 6 months after the start of combined treatment. Results are reported as the mean standard deviation. All analyses were performed using SPSS version 19 (SPSS Inc., Chicago, IL, USA). The effect of sitagliptin treatment was assessed by one-way analysis of variance (ANOVA) and statistical significance was accepted at p < 0.05. This study was approved by the Ethics Committee of the Kanagawa Physicians Association, and was registered with the Clinical Trials Registry (http://clinicaltrials.gov; NCT01855087).
Results
A total of 1004 patients were analyzed after excluding 53 patients who received add-on sitagliptin for less than 6 months, 81 patients with an HbA1c
