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Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea: a 24-week, multicentre, randomized, double-blind, placebo-controlled study (TROICA study).
Diabetes Obes Metab. 2017 05; 19(5):635-643.DO

Abstract

AIMS

To assess the efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, added to metformin and sulphonylurea in patients with type 2 diabetes (T2DM).

MATERIALS AND METHODS

We conducted a randomized, double-blind, placebo-controlled trial in 219 Korean patients inadequately controlled with metformin and glimepiride. Participants were randomized to gemigliptin 50 mg once daily or placebo added to metformin and glimepiride. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24.

RESULTS

The baseline HbA1c was 8.2% in both groups. The addition of gemigliptin to metformin and glimepiride significantly reduced HbA1c levels at week 24 compared with placebo (between-group difference in adjusted mean change -0.87%, 95% confidence interval [CI] -1.09% to -0.64%). Fasting plasma glucose level was also significantly reduced with gemigliptin (-0.93 mmol/L, 95% CI -1.50 to -0.35 mmol/L), and a higher proportion of participants achieved an HbA1c level of <7% (39.3% vs 5.5%; P <.001) in the gemigliptin group than in the placebo group. Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (-0.21 mmol/L, 95% CI -0.38 to -0.03 mmol/L for total cholesterol, -0.18 mmol/L, 95% CI -0.34 to -0.01 mmol/L for LDL cholesterol). The incidence of hypoglycaemia was 9.4% in the gemigliptin group and 2.7% in the placebo group.

CONCLUSIONS

Gemigliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin and sulphonylurea. The incidence of hypoglycaemia was higher with gemigliptin than with placebo, which highlights the importance of optimal dose adjustment for sulphonylurea.

Authors+Show Affiliations

Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.Department of Internal Medicine, Eulji General Hospital, Seoul, Korea.Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea.Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Seoul, Korea.Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.Department of Internal Medicine, Yeungnam University Medical Centre, Daegu, Korea.Department of Internal Medicine, Wonkwang University School of Medicine and Hospital, Iksan, Korea.Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, Korea.Department of Internal Medicine, Chonbuk National University Hospital, Jeonju, Korea.Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.Department of Internal Medicine, CHA Bundang Medical Center, Seongnam, Korea.Department of Internal Medicine, Soonchunhyang University Hospital, Seoul, Korea.Department of Internal Medicine, Daedong General Hospital, Busan, Korea.Department of Internal Medicine, Kangwon National University Hospital, Chuncheon, Korea.Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea.Department of Internal Medicine, Sejong General Hospital, Bucheon, Korea.LG Life Sciences, Seoul, Korea.Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Korea.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28026912

Citation

Ahn, Chang Ho, et al. "Efficacy and Safety of Gemigliptin, a Dipeptidyl Peptidase-4 Inhibitor, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Combination Treatment of Metformin and Sulphonylurea: a 24-week, Multicentre, Randomized, Double-blind, Placebo-controlled Study (TROICA Study)." Diabetes, Obesity & Metabolism, vol. 19, no. 5, 2017, pp. 635-643.
Ahn CH, Han KA, Yu JM, et al. Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea: a 24-week, multicentre, randomized, double-blind, placebo-controlled study (TROICA study). Diabetes Obes Metab. 2017;19(5):635-643.
Ahn, C. H., Han, K. A., Yu, J. M., Nam, J. Y., Ahn, K. J., Oh, T. K., Lee, H. W., Lee, D. H., Kim, J., Chung, C. H., Park, T. S., Kim, B. J., Park, S. W., Park, H. K., Lee, K. J., Kim, S. W., Park, J. H., Ko, K. P., Kim, C. H., ... Park, K. S. (2017). Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea: a 24-week, multicentre, randomized, double-blind, placebo-controlled study (TROICA study). Diabetes, Obesity & Metabolism, 19(5), 635-643. https://doi.org/10.1111/dom.12866
Ahn CH, et al. Efficacy and Safety of Gemigliptin, a Dipeptidyl Peptidase-4 Inhibitor, in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Combination Treatment of Metformin and Sulphonylurea: a 24-week, Multicentre, Randomized, Double-blind, Placebo-controlled Study (TROICA Study). Diabetes Obes Metab. 2017;19(5):635-643. PubMed PMID: 28026912.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea: a 24-week, multicentre, randomized, double-blind, placebo-controlled study (TROICA study). AU - Ahn,Chang Ho, AU - Han,Kyung Ah, AU - Yu,Jae Myung, AU - Nam,Joo Young, AU - Ahn,Kyu Jeung, AU - Oh,Tae Keun, AU - Lee,Hyoung Woo, AU - Lee,Dae Ho, AU - Kim,Jaetaek, AU - Chung,Choon Hee, AU - Park,Tae Sun, AU - Kim,Byung Joon, AU - Park,Seok Won, AU - Park,Hyeong Kyu, AU - Lee,Kwang Jae, AU - Kim,Sang-Wook, AU - Park,Jeong Hyun, AU - Ko,Kwan Pyo, AU - Kim,Chong Hwa, AU - Lee,Hyunjin, AU - Jang,Hak Chul, AU - Park,Kyong Soo, Y1 - 2017/02/17/ PY - 2016/08/25/received PY - 2016/11/11/revised PY - 2016/12/22/accepted PY - 2016/12/28/pubmed PY - 2017/10/11/medline PY - 2016/12/28/entrez KW - DPP-4 inhibitor KW - clinical trial KW - phase III study SP - 635 EP - 643 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 19 IS - 5 N2 - AIMS: To assess the efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, added to metformin and sulphonylurea in patients with type 2 diabetes (T2DM). MATERIALS AND METHODS: We conducted a randomized, double-blind, placebo-controlled trial in 219 Korean patients inadequately controlled with metformin and glimepiride. Participants were randomized to gemigliptin 50 mg once daily or placebo added to metformin and glimepiride. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. RESULTS: The baseline HbA1c was 8.2% in both groups. The addition of gemigliptin to metformin and glimepiride significantly reduced HbA1c levels at week 24 compared with placebo (between-group difference in adjusted mean change -0.87%, 95% confidence interval [CI] -1.09% to -0.64%). Fasting plasma glucose level was also significantly reduced with gemigliptin (-0.93 mmol/L, 95% CI -1.50 to -0.35 mmol/L), and a higher proportion of participants achieved an HbA1c level of <7% (39.3% vs 5.5%; P <.001) in the gemigliptin group than in the placebo group. Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (-0.21 mmol/L, 95% CI -0.38 to -0.03 mmol/L for total cholesterol, -0.18 mmol/L, 95% CI -0.34 to -0.01 mmol/L for LDL cholesterol). The incidence of hypoglycaemia was 9.4% in the gemigliptin group and 2.7% in the placebo group. CONCLUSIONS: Gemigliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin and sulphonylurea. The incidence of hypoglycaemia was higher with gemigliptin than with placebo, which highlights the importance of optimal dose adjustment for sulphonylurea. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/28026912/Efficacy_and_safety_of_gemigliptin_a_dipeptidyl_peptidase_4_inhibitor_in_patients_with_type_2_diabetes_mellitus_inadequately_controlled_with_combination_treatment_of_metformin_and_sulphonylurea:_a_24_week_multicentre_randomized_double_blind_placebo_controlled_study__TROICA_study__ L2 - https://doi.org/10.1111/dom.12866 DB - PRIME DP - Unbound Medicine ER -