Multicenter prospective observational study of teneligliptin, a selective dipeptidyl peptidase-4 inhibitor, in patients with poorly controlled type 2 diabetes: Focus on glycemic control, hypotensive effect, and safety Chikushi Anti-Diabetes Mellitus Trial-Teneligliptin (CHAT-T)

ABSTRACT

Objective: We purpose to confirm the effect of teneligliptin (Tenelia), a selective dipeptidyl peptidase-4 (DPP-4) inhibitor, on glycemic control and non-glucose risk factors for macroangiopathy, including blood pressure, lipid metabolism, and body weight.

Methods: In a prospective, multicenter, open-label, observational study, teneligliptin (20 mg/day) was administered to type 2 diabetic patients with poor glycemic control (HbA1c ≥ 6.5% to <10%) at our hospitals. The safety of teneligliptin and its impact on blood glucose, blood pressure, and the lipid profile were assessed after administration for 3 and 6 months.

Results: One hundred and sixty-two patients were enrolled between February 2014 and August 2015. HbA1c was 7.6% at baseline and showed significant reduction to 7.1% after 3 months of treatment and to 6.9% after 6 months (both p < 0.01). Patients with poorly controlled hypertension (systolic blood pressure [SBP] ≥130 mmHg and/or diastolic blood pressure [DBP] ≥80 mmHg) at study initiation were extracted to investigate the effect of teneligliptin on blood pressure. SBP showed a significant decrease from 141.2 ± 9.8 mmHg at baseline to 131.1 ± 14.3 mmHg after 3 months and 133.9 ± 11.5 mmHg after 6 months (both p < 0.001). DBP also decreased significantly from 85.8 ± 5.7 mmHg at baseline to 78.4 ± 10.0 mmHg after 3 months and 79.7 ± 10.1 mmHg after 6 months (both p < 0.001). Adverse events were pruritus in four patients, and cerebral infarction was reported as a cerebrovascular event in one patient.

Conclusions: Teneligliptin therapy was safe and improved glycemic control irrespective of baseline HbA1c. Blood pressure was also improved in patients with concomitant hypertension.

KEYWORDS:

• teneligliptin
• dipeptidyl peptidase-4 inhibitor
• glycemic control
• hypotensive effect
• safety

Acknowledgments

We would like to express our sincere gratitude K.K. for scientific advice for final revising the manuscript. We thank Ms. Nao Totake for her excellent technical assistance. We also thank the following members of Chikushi Cardiovascular Research Network for recruiting patients to participate in the study: Kunihide Ishii (Asakura Medical Association Hospital), Kimishige Imoto (Imoto clinic), Hiroshi Kutsukake (Kutsukake Clinic), Takehiko Kodera (Kodera Internal Clinic), Masanori Shimizu (Shimizu Clinic), Hiroshi Sugawara (Sugawara Clinic), Yohichi Tanabe (Tanabe Clinic), Yoichi Tsuruta (TSURUTA CLINIC), Yasuo Tomita (Tomita Clinic), Yuichiro Nakamura (NAKAMURA CARDIOVASCULAR CLINIC), Tomoko Hyodo (Kitajima Clinic), Kenkichi Majima (MAJIMA CLINIC), Tadasu Matsuzaki (Matsuzaki Clinic), Shunji Miake (sugi hospital), Masahiko Mohri (mori geka), Shoichiro Mori (Mori Clinic), Chifumi Yamamoto (Yamamoto Internal Medicine & Gastroenterology), Tadachika Kudo (Fukuoka University Chikushi Hospital) and Ryoko Mitsutake (Fukuoka University Chikushi Hospital).

Additional information

Funding

The authors have received financial support from Mitsubishi Tanabe Pharma Corporation (120687FK, 120688FK, 130669FK, and 130670FK).