Factors Predicting Therapeutic Efficacy of Combination Treatment With Sitagliptin and Insulin in Type 2 Diabetic Patients: The ASSIST-K Study

Masashi Ishikawa, Masahiko Takai, Hajime Maeda, Akira Kanamori, Akira Kubota, Hikaru Amemiya, Takashi Iizuka, Kotaro Iemitsu, Tomoyuki Iwasaki, Goro Uehara, Shinichi Umezawa, Mitsuo Obana, Hideaki Kaneshige, Mizuki Kaneshiro, Takehiro Kawata, Nobuo Sasai, Tatsuya Saito, Tetsuo Takuma, Hiroshi Takeda, Keiji Tanaka, Nobuaki Tsurui, Shigeru Nakajima, Kazuhiko Hoshino, Shin Honda, Hideo Machimura, Kiyokazu Matoba, Fuyuki Minagawa, Nobuaki Minami, Yukiko Miyairi, Atsuko Mokubo, Tetsuya Motomiya, Manabu Waseda, Masaaki Miyakawa, Yoshikazu Naka, Yasuo Terauchi, Yasushi Tanaka, Ikuro Matsuba


Background: It is unclear whether dipeptidyl peptidase-4 inhibitors decrease hemoglobin A1c (HbA1c) in a glucose-dependent manner in patients on insulin therapy who have impaired insulin secretion. This study investigated factors influencing the efficacy of sitagliptin when used concomitantly with insulin to treat type 2 diabetes mellitus (T2DM) in the real-world setting.

Methods: A retrospective study was conducted of 1,004 T2DM patients at 36 Japanese clinics associated with the Diabetes Task Force of the Kanagawa Physicians Association. Eligible patients had been on insulin for at least 6 months, with a baseline HbA1c of 7.0% (53 mmol/mol) or higher. Baseline characteristics and laboratory data from 495 patients were subjected to multiple regression analysis to identify factors influencing the change of HbA1c.

Results: Most patients (n = 809) received sitagliptin at a dose of 50 mg. In the 1,004 patients, HbA1c decreased by 0.74% (6 mmol/mol) and body weight increased by 0.1 kg after 6 months of combination therapy. Multiple regression analysis showed that a higher baseline HbA1c, older age, and lower body mass index influenced the change of HbA1c after 6 months. Hypoglycemic symptoms occurred in 7.4%, but none were severe.

Conclusions: These results emphasize the importance of a higher HbA1c at the commencement of sitagliptin therapy in patients on insulin. Glucose-dependent suppression of glucagon secretion by sitagliptin may be useful in patients with impaired insulin secretion. Sitagliptin can be used concomitantly with insulin irrespective of the insulin regimen, duration of insulin treatment, and concomitant medications.

J Clin Med Res. 2015;7(8):607-612
doi: http://dx.doi.org/10.14740/jocmr2149w


Type 2 diabetes; Sitagliptin; Insulin; Combination therapy; HbA1c; Multiple regression analysis; Body weight

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