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Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period

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journal contribution
posted on 10.08.2017, 10:38 by Takashi Kadowaki, Kazuoki Kondo, Noriyuki Sasaki, Kyoko Miyayama, Shoko Yokota, Ryuji Terata, Maki Gouda

Objective: To assess the efficacy and safety of teneligliptin as add-on to insulin monotherapy in patients with type 2 diabetes mellitus (T2DM).

Research design and methods: In a 16-week, double-blind period, 148 Japanese T2DM patients with inadequate glycemic control with insulin and diet/exercise therapies were randomized to placebo or teneligliptin 20 mg. In a subsequent 36-week, open-label period, all patients received teneligliptin once daily. The primary outcome measure was change in HbA1c at the end of the double-blind period.

Results: The difference between placebo and teneligliptin in change in HbA1c in the double-blind period (least squares mean ± SE) was −0.80% ± 0.11%; teneligliptin was superior (ANCOVA, P < 0.001). The HbA1c-lowering effect of teneligliptin was maintained throughout the open-label period. The incidence of adverse events was 53.5% with placebo and 44.2% with teneligliptin in the double-blind period, 66.7% in the placebo/teneligliptin group in the open-label period, and 77.9% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. The incidence of hypoglycemic symptoms was 11.1% in the placebo/teneligliptin group in the open-label period and 27.3% in the teneligliptin/teneligliptin group over both double-blind/open-label periods.

Conclusion: Teneligliptin was effective and well tolerated in Japanese T2DM patients with inadequate glycemic control.

Clinical trial registration: NCT02081599

Funding

This study was funded by Mitsubishi Tanabe Pharma Corporation, and is registered with ClinicalTrials.gov (NCT02081599).

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