Diabetes Metab J.  2021 Jul;45(4):606-612. 10.4093/dmj.2020.0047.

A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin (LC15-0444) Monotherapy in Patients with Type 2 Diabetes Mellitus

• Yang SJ
• Min KW
• Gupta SK
• Park JY
• K.Shivane V
• Agarwal PK
• Kim DM
• Kim YE
• Baik SH

• KMID: 2518902
• DOI: http://doi.org/10.4093/dmj.2020.0047

Abstract

The purpose of this extension study was to assess the long-term efficacy and safety of gemigliptin 50 mg in patients with type 2 diabetes mellitus (T2DM). Patients with T2DM who had completed the initial 24-week study comparing gemigliptin monotherapy with placebo were eligible to enrol. In the open-label, 28-week extension study, all enrolled patients received gemigliptin, regardless of the treatment received during the initial 24-week study period. The mean reduction±standard deviation (SD) in glycosylated hemoglobin (HbA1c) observed after 24 weeks of treatment (–0.6%±1.1%) was further decreased for the gemi-gemi group and the mean change in HbA1c at week 52 from baseline was –0.9%±1.2% (P<0.0001). For the pbo-gemi group, HbA1c decreased after they were switched to gemigliptin, and the mean change in HbA1c at week 52 from baseline was –0.7%±1.2% (P<0.0001). Furthermore, the overall incidence of adverse events demonstrated that gemigliptin was safe and well tolerated up to 52 weeks.

Keyword

Diabetes mellitus, type 2; Dipeptidyl-peptidase IV inhibitors; LC15-0444

Figure

• 

  Fig. 1. (A) Mean glycosylated hemoglobin (HbA1c) over time (full analysis set [FAS]). (B) Percentages of responders achieving HbA1c <7% or <6.5% (FAS). pbo-gemi group=placebo→gemigliptin; gemi-gemi group=gemigliptin→gemigliptin. aP<0.0001.

Reference

1. Scheen AJ. A review of gliptins in 2011. Expert Opin Pharmacother. 2012; 13:81–99.

2. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012; 35:1364–79.

3. Craddy P, Palin HJ, Johnson KI. Comparative effectiveness of dipeptidylpeptidase-4 inhibitors in type 2 diabetes: a systematic review and mixed treatment comparison. Diabetes Ther. 2014; 5:1–41.

4. Ahren B. Clinical results of treating type 2 diabetic patients with sitagliptin, vildagliptin or saxagliptin: diabetes control and potential adverse events. Best Pract Res Clin Endocrinol Metab. 2009; 23:487–98.

5. Nauck MA, Vilsboll T, Gallwitz B, Garber A, Madsbad S. Incretin-based therapies: viewpoints on the way to consensus. Diabetes Care. 2009; 32 Suppl 2:S223–31.

6. Yang SJ, Min KW, Gupta SK, Park JY, Shivane VK, Pitale SU, et al. A multicentre, multinational, randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of gemigliptin (LC15-0444) in patients with type 2 diabetes. Diabetes Obes Metab. 2013; 15:410–6.

7. Monami M, Iacomelli I, Marchionni N, Mannucci E. Dipeptydil peptidase-4 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis. 2010; 20:224–35.

8. Richard KR, Shelburne JS, Kirk JK. Tolerability of dipeptidyl peptidase-4 inhibitors: a review. Clin Ther. 2011; 33:1609–29.

9. Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007; 298:194–206.