Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies |
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Authors: | Takashi Kadowaki Fuyuhiko Marubayashi Shoko Yokota Makoto Katoh Hiroaki Iijima |
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Affiliation: | 1. The University of Tokyo, Graduate School of Medicine, Department of Metabolic Disease, Tokyo, Japan;2. Mitsubishi Tanabe Pharma Corp, Development Division, Clinical Research Department II, Tokyo, Japan;3. Mitsubishi Tanabe Pharma Corp, Development Division, Data Science Department, Tokyo, Japan;4. Mitsubishi Tanabe Pharma Corp, Pharmacovigilance and Quality Assurance Division, Medical Affairs Department, Tokyo, Japan;5. Mitsubishi Tanabe Pharma Corp, Pharmacovigilance and Quality Assurance Division, Medical Affairs Department, 3-16-89 Kashima, Yodogawa-ku, Osaka 532-8505, Japan +81 6 6300 3063;6. +81 6 6300 2655;7. Iijima.Hiroaki@mm.mt-pharma.co.jp |
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Abstract: | Objective: To assess the safety and efficacy of long-term administration of teneligliptin alone and in combination with oral antidiabetic drugs in Japanese type 2 diabetes mellitus (T2DM) patients with insufficient glycemic control. Methods: This post-hoc pooled analysis used data from two Phase III clinical studies involving 702 Japanese patients. We evaluated teneligliptin as monotherapy and combined with a sulfonylurea, glinide, biguanide, or α-glucosidase inhibitor. Safety measures included adverse events (AEs), adverse reactions and hypoglycemia. The main efficacy measure was the change in glycated hemoglobin (HbA1c) from baseline. Results: Incidences of AEs and adverse reactions were similar among the teneligliptin monotherapy group and all combination therapy groups except the combination with sulfonylurea. Hypoglycemia was more frequent in the sulfonylurea combination therapy group than in other groups. Teneligliptin administered once daily as monotherapy or combination therapy resulted in a decrease in HbA1c, which was maintained for 52 weeks. Bodyweight showed no change or a slight increase at the end of 52 weeks in all groups. Conclusions: This pooled analysis provides evidence for the safety and efficacy of long-term use of teneligliptin as monotherapy or combination therapy in Japanese T2DM patients. |
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Keywords: | co-administration Japanese Phase III pooled analysis teneligliptin type 2 diabetes |
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