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, Obesity and Metabolism

Volumn 15, Issue 5, 2013, Pages 410-416

  Yang, S J ^a   Min, K W ^b   Gupta, S K ^c   Park, J Y ^d   Shivane, V K ^e   Pitale, S U ^f   Agarwal, P K ^g   Sosale, A ^h   Gandhi, P ⁱ   Dharmalingam, M ^j   Mohan, V ^k   Mahesh, U ^l   Kim, D M ^m   Kim, Y S ⁿ   Kim, J A ^o   Kim, P K ^o   Baik, S H ^a  

^a Korea University College of Medicine   (South Korea)

^b Eulji University School of Medicine   (South Korea)

^c MV Hospital and Research Centre   (India)

^d University of Ulsan College of Medicine   (South Korea)

^e RHIDEM   (India)

^f Pitale Diabetes and Hormone Center   (India)

^g Hormone Care and Research Center   (India)

^h Diacon Hospital   (India)

ⁱ Gandhi Research Institute   (India)

^j Bangalore Endocrinology and Diabetes Research Center   (India)

^k MADRAS DIABETES RESEARCH FOUNDATION   (India)

^l MV Hospital for Diabetes   (India)

^m Hallym University College of Medicine   (South Korea)

ⁿ Inha University Hospital   (South Korea)

^o LG Chemical Ltd   (South Korea)

more..

Author keywords

DPP IV inhibitor; Gemigliptin; LC15 0444; Type 2 diabetes

Indexed keywords

GEMIGLIPTIN; GLUCOSE; HEMOGLOBIN A1C; LC 15 0444; PLACEBO; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CONSTIPATION; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DIET RESTRICTION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; GLUCOSE BLOOD LEVEL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INDIA; KOREA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; ORAL GLUCOSE TOLERANCE TEST; PHASE 3 CLINICAL TRIAL; PLACEBO EFFECT; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION;

AGED; AGED, 80 AND OVER; BLOOD GLUCOSE; COMBINED MODALITY THERAPY; DIABETES MELLITUS, TYPE 2; DIET; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; EXERCISE; FASTING; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; INDIA; MALE; MIDDLE AGED; PIPERIDONES; PYRIMIDINES; REPUBLIC OF KOREA; RISK REDUCTION BEHAVIOR;

EID: 84876327970     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12042     Document Type: Article

References (14)

1. Karras S, Goulis DG, Mintziori G, Katsiki N, Tzotzas T. The effects of incretins on energy homeostasis: physiology and implications for the treatment of type 2 diabetes mellitus and obesity. Curr Vasc Pharmacol 2012; 10: 781-791.
2. Ussher JR, Drucker DJ. Cardiovascular biology of the incretin system. Endocr Rev 2012; 33: 187-215.
3. Ahren B. The future of incretin-based therapy: novel avenues-novel targets. Diabetes Obes Metab 2011; 13(Suppl. 1): 158-166.
4. Wang B, Ni Y, Zhong J, Sun F. Effects of incretins on blood pressure: a promising therapy for type 2 diabetes mellitus with hypertension. J Diabetes 2012; 4: 22-29.
5. Lim KS, Cho JY, Kim BH et al. Pharmacokinetics and pharmacodynamics of LC15-0444, a novel dipeptidyl peptidase IV inhibitor, after multiple dosing in healthy volunteers. Br J Clin Pharmacol 2009; 68: 883-890.
6. Lim KS, Kim JR, Choi YJ et al. Pharmacokinetics, pharmacodynamics, and tolerability of the dipeptidyl peptidase IV inhibitor LC15-0444 in healthy Korean men: a dose-block-randomized, double-blind, placebo-controlled, ascending single-dose Phase I study. Clin Ther 2008; 30: 1817-1830.
7. Rhee EJ, Lee WY, Yoon KH et al. A multicenter, randomized, placebo-controlled, double-blind phase II trial evaluating the optimal dose, efficacy and safety of LC 15-0444 in patients with type 2 diabetes. Diabetes Obes Metab 2010; 12: 1113-1119.
8. Mohan V, Yang W, Son HY et al. Efficacy and safety of sitagliptin in the treatment of patients with type 2 diabetes in China, India, and Korea. Diabetes Res Clin Pract 2009; 83: 106-116.
9. Fadini GP, de Kreutzenberg SV, Gjini R, Avogaro A. The metabolic syndrome influences the response to incretin-based therapies. Acta Diabetol 2011; 48: 219-225.
10. Gerich J. DPP-4 inhibitors: what may be the clinical differentiators? Diabetes Res Clin Pract 2010; 90: 131-140.
11. Richter B, Bandeira-Echtler E, Bergerhoff K, Lerch CL. Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus. Cochrane Database Syst Rev 2008; 2: CD006739.
12. Rosenstock J, Aguilar-Salinas C, Klein E, Nepal S, List J, Chen R. Effect of saxagliptin monotherapy in treatment-naive patients with type 2 diabetes. Curr Med Res Opin 2009; 25: 2401-2411.
13. DeFronzo RA, Fleck PR, Wilson CA, Mekki Q. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care 2008; 31: 2315-2317.
14. Bergman AJ, Stevens C, Zhou Y et al. Pharmacokinetic and pharmacodynamic properties of multiple oral doses of sitagliptin, a dipeptidyl peptidase-IV inhibitor: a double-blind, randomized, placebo-controlled study in healthy male volunteers. Clin Ther 2006; 28: 55-72.