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Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension.
Diabetes Obes Metab. 2014 May; 16(5):418-25.DO

Abstract

AIMS

To assess the efficacy and safety of teneligliptin in combination with glimepiride in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with glimepiride monotherapy.

METHODS

In the initial 12-week, double-blind, placebo-controlled, parallel-group period, 194 patients [haemoglobin A1c (HbA1c): 8.4 ± 0.8%; fasting plasma glucose (FPG): 164.2 ± 28.1 mg/dl] were randomized to either teneligliptin 20 mg or placebo once daily while continuing stable glimepiride therapy. This randomized period was then followed by a 40-week, open-label period, where all patients received teneligliptin once daily. The primary endpoint was the change in HbA1c from baseline to week 12.

RESULTS

Teneligliptin reduced HbA1c significantly compared with placebo at week 12. The placebo-subtracted change in HbA1c was -1.0 ± 0.1% [least-squares (LS) mean ± s.e., p < 0.001]. Teneligliptin also significantly reduced FPG and 2-h postprandial glucose (PPG) as compared with placebo at week 12; the placebo-subtracted changes were -27.1 ± 3.2 and -49.1 ± 6.2 mg/dl (LS mean ± s.e., both p < 0.001), respectively. The blood glucose-lowering effects were sustained throughout the 40-week open-label period. The incidence rates of adverse events and adverse drug reactions, including hypoglycaemia, during the double-blind randomized period were similar in both groups. Therefore, teneligliptin was generally well tolerated when used in combination with glimepiride.

CONCLUSIONS

The addition of teneligliptin was effective and generally well tolerated in Japanese patients with T2DM inadequately controlled with glimepiride monotherapy. The improvements in glycaemic control were maintained for up to 52 weeks.

Authors+Show Affiliations

Department of Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.No affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24205974

Citation

Kadowaki, T, and K Kondo. "Efficacy and Safety of Teneligliptin Added to Glimepiride in Japanese Patients With Type 2 Diabetes Mellitus: a Randomized, Double-blind, Placebo-controlled Study With an Open-label, Long-term Extension." Diabetes, Obesity & Metabolism, vol. 16, no. 5, 2014, pp. 418-25.
Kadowaki T, Kondo K. Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014;16(5):418-25.
Kadowaki, T., & Kondo, K. (2014). Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes, Obesity & Metabolism, 16(5), 418-25. https://doi.org/10.1111/dom.12235
Kadowaki T, Kondo K. Efficacy and Safety of Teneligliptin Added to Glimepiride in Japanese Patients With Type 2 Diabetes Mellitus: a Randomized, Double-blind, Placebo-controlled Study With an Open-label, Long-term Extension. Diabetes Obes Metab. 2014;16(5):418-25. PubMed PMID: 24205974.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. AU - Kadowaki,T, AU - Kondo,K, Y1 - 2013/12/10/ PY - 2013/05/15/received PY - 2013/06/19/revised PY - 2013/11/02/accepted PY - 2013/11/12/entrez PY - 2013/11/12/pubmed PY - 2015/1/24/medline KW - DPP-4 inhibitor KW - HbA1c KW - Japanese KW - glimepiride KW - teneligliptin KW - type 2 diabetes mellitus SP - 418 EP - 25 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 16 IS - 5 N2 - AIMS: To assess the efficacy and safety of teneligliptin in combination with glimepiride in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with glimepiride monotherapy. METHODS: In the initial 12-week, double-blind, placebo-controlled, parallel-group period, 194 patients [haemoglobin A1c (HbA1c): 8.4 ± 0.8%; fasting plasma glucose (FPG): 164.2 ± 28.1 mg/dl] were randomized to either teneligliptin 20 mg or placebo once daily while continuing stable glimepiride therapy. This randomized period was then followed by a 40-week, open-label period, where all patients received teneligliptin once daily. The primary endpoint was the change in HbA1c from baseline to week 12. RESULTS: Teneligliptin reduced HbA1c significantly compared with placebo at week 12. The placebo-subtracted change in HbA1c was -1.0 ± 0.1% [least-squares (LS) mean ± s.e., p < 0.001]. Teneligliptin also significantly reduced FPG and 2-h postprandial glucose (PPG) as compared with placebo at week 12; the placebo-subtracted changes were -27.1 ± 3.2 and -49.1 ± 6.2 mg/dl (LS mean ± s.e., both p < 0.001), respectively. The blood glucose-lowering effects were sustained throughout the 40-week open-label period. The incidence rates of adverse events and adverse drug reactions, including hypoglycaemia, during the double-blind randomized period were similar in both groups. Therefore, teneligliptin was generally well tolerated when used in combination with glimepiride. CONCLUSIONS: The addition of teneligliptin was effective and generally well tolerated in Japanese patients with T2DM inadequately controlled with glimepiride monotherapy. The improvements in glycaemic control were maintained for up to 52 weeks. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/24205974/Efficacy_and_safety_of_teneligliptin_added_to_glimepiride_in_Japanese_patients_with_type_2_diabetes_mellitus:_a_randomized_double_blind_placebo_controlled_study_with_an_open_label_long_term_extension_ L2 - https://doi.org/10.1111/dom.12235 DB - PRIME DP - Unbound Medicine ER -