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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.
Expert Opin Pharmacother. 2017 Sep; 18(13):1291-1300.EO

Abstract

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.

Authors+Show Affiliations

a Department of Diabetes and Metabolic Diseases, Graduate School of Medicine , The University of Tokyo , Tokyo , Japan.b Integrated Value Development , Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.b Integrated Value Development , Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.b Integrated Value Development , Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.b Integrated Value Development , Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.b Integrated Value Development , Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.b Integrated Value Development , Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28741385

Citation

Kadowaki, Takashi, et al. "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." Expert Opinion On Pharmacotherapy, vol. 18, no. 13, 2017, pp. 1291-1300.
Kadowaki T, Kondo K, Sasaki N, et al. 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. Expert Opin Pharmacother. 2017;18(13):1291-1300.
Kadowaki, T., Kondo, K., Sasaki, N., Miyayama, K., Yokota, S., Terata, R., & Gouda, M. (2017). 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. Expert Opinion On Pharmacotherapy, 18(13), 1291-1300. https://doi.org/10.1080/14656566.2017.1359259
Kadowaki T, et al. 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. Expert Opin Pharmacother. 2017;18(13):1291-1300. PubMed PMID: 28741385.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Kadowaki,Takashi, AU - Kondo,Kazuoki, AU - Sasaki,Noriyuki, AU - Miyayama,Kyoko, AU - Yokota,Shoko, AU - Terata,Ryuji, AU - Gouda,Maki, Y1 - 2017/08/10/ PY - 2017/7/26/pubmed PY - 2017/12/5/medline PY - 2017/7/26/entrez KW - Diabetes mellitus KW - Japanese KW - combination KW - drug therapy KW - insulin KW - teneligliptin KW - type 2 SP - 1291 EP - 1300 JF - Expert opinion on pharmacotherapy JO - Expert Opin Pharmacother VL - 18 IS - 13 N2 - 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. SN - 1744-7666 UR - https://www.unboundmedicine.com/medline/citation/28741385/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_ L2 - https://www.tandfonline.com/doi/full/10.1080/14656566.2017.1359259 DB - PRIME DP - Unbound Medicine ER -