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Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes.
Diabetes Obes Metab. 2018 01; 20(1):77-84.DO

Abstract

AIM

To evaluate the long-term safety and efficacy of canagliflozin as add-on therapy in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control with teneligliptin monotherapy.

METHODS

This open-label 52-week study was conducted in Japan. Patients received canagliflozin 100 mg added to teneligliptin 20 mg orally once daily for 52 weeks. The safety endpoint was the incidence of adverse events (AEs). The efficacy endpoints included changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and body weight from baseline to week 52 (with last observation carried forward).

RESULTS

Overall, 153 patients entered the treatment period and 142 completed the study. The overall incidence rates of AEs and drug-related AEs were 69.9% and 22.9%, respectively. Most AEs and drug-related AEs were mild or moderate in severity. There were no previously undescribed safety signals. The mean changes in HbA1c, FPG and body weight were -0.99% (95% confidence interval [CI] -1.12 to -0.85), -38.6 mg/dL (95% CI -43.4 to -33.9) and -3.92% (95% CI -4.53 to -3.31), respectively. These effects were maintained for 52 weeks without attenuation. HbA1c and body weight were both decreased in 82.24% of patients at the end of the treatment period. Reductions in postprandial glucose were observed at weeks 24 and 52.

CONCLUSIONS

No new safety risks with this combination were identified, and sustained improvements in HbA1c, FPG and body weight were observed. The findings suggest that long-term co-administration of canagliflozin with teneligliptin is well tolerated and effective in Japanese patients with T2DM who have inadequate glycaemic control on teneligliptin alone.

Authors+Show Affiliations

Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.Department of Diabetes, Endocrinology, and Nutrition, Graduate School of Medicine, Kyoto University, Kyoto, Japan.Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.Ikuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

28608617

Citation

Kadowaki, Takashi, et al. "Long-term Safety and Efficacy of Canagliflozin as Add-on Therapy to Teneligliptin in Japanese Patients With Type 2 Diabetes." Diabetes, Obesity & Metabolism, vol. 20, no. 1, 2018, pp. 77-84.
Kadowaki T, Inagaki N, Kondo K, et al. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2018;20(1):77-84.
Kadowaki, T., Inagaki, N., Kondo, K., Nishimura, K., Kaneko, G., Maruyama, N., Nakanishi, N., Watanabe, Y., Gouda, M., & Iijima, H. (2018). Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes, Obesity & Metabolism, 20(1), 77-84. https://doi.org/10.1111/dom.13038
Kadowaki T, et al. Long-term Safety and Efficacy of Canagliflozin as Add-on Therapy to Teneligliptin in Japanese Patients With Type 2 Diabetes. Diabetes Obes Metab. 2018;20(1):77-84. PubMed PMID: 28608617.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. AU - Kadowaki,Takashi, AU - Inagaki,Nobuya, AU - Kondo,Kazuoki, AU - Nishimura,Kenichi, AU - Kaneko,Genki, AU - Maruyama,Nobuko, AU - Nakanishi,Nobuhiro, AU - Watanabe,Yumi, AU - Gouda,Maki, AU - Iijima,Hiroaki, Y1 - 2017/07/31/ PY - 2017/04/05/received PY - 2017/06/08/revised PY - 2017/06/09/accepted PY - 2017/6/14/pubmed PY - 2018/7/28/medline PY - 2017/6/14/entrez KW - DPP-4 inhibitor KW - SGLT2 inhibitor KW - canagliflozin KW - teneligliptin KW - type 2 diabetes mellitus SP - 77 EP - 84 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 20 IS - 1 N2 - AIM: To evaluate the long-term safety and efficacy of canagliflozin as add-on therapy in patients with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control with teneligliptin monotherapy. METHODS: This open-label 52-week study was conducted in Japan. Patients received canagliflozin 100 mg added to teneligliptin 20 mg orally once daily for 52 weeks. The safety endpoint was the incidence of adverse events (AEs). The efficacy endpoints included changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG) and body weight from baseline to week 52 (with last observation carried forward). RESULTS: Overall, 153 patients entered the treatment period and 142 completed the study. The overall incidence rates of AEs and drug-related AEs were 69.9% and 22.9%, respectively. Most AEs and drug-related AEs were mild or moderate in severity. There were no previously undescribed safety signals. The mean changes in HbA1c, FPG and body weight were -0.99% (95% confidence interval [CI] -1.12 to -0.85), -38.6 mg/dL (95% CI -43.4 to -33.9) and -3.92% (95% CI -4.53 to -3.31), respectively. These effects were maintained for 52 weeks without attenuation. HbA1c and body weight were both decreased in 82.24% of patients at the end of the treatment period. Reductions in postprandial glucose were observed at weeks 24 and 52. CONCLUSIONS: No new safety risks with this combination were identified, and sustained improvements in HbA1c, FPG and body weight were observed. The findings suggest that long-term co-administration of canagliflozin with teneligliptin is well tolerated and effective in Japanese patients with T2DM who have inadequate glycaemic control on teneligliptin alone. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/28608617/Long_term_safety_and_efficacy_of_canagliflozin_as_add_on_therapy_to_teneligliptin_in_Japanese_patients_with_type_2_diabetes_ DB - PRIME DP - Unbound Medicine ER -