A multi-center, multi-national, randomized, placebo-controlled, parallel group, double-blind, Phase III trial to evaluate the efficacy and safety of LC15-0444 in patients with type 2 diabetes.

LG Life Sciences Ltd9 个研究点分布在 1 个国家目标入组 180 人开始时间: 2010年7月13日最近更新: 2013年2月28日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 180
试验地点: 9
主要终点: Efficacy Outcome: reduction of HbA1c in test group from baseline compared to the placebo group

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This clinical study is a randomised, double-blind, placebo-controlled, parallel, multi-country, multi center phase III trial to evaluate efficacy and safety of LC15 - 0444, in diabetic patients, Subjects who consent to the extension study after completion of 24 Week treatment period, will enter the additional 28 week extension study subjects in the palcebo group will be treated with LC15 0444 in an oral dose of 50 m.g. in the extension study. This study is ongoing at 05 investigator sites in DPR Korea, with targeted recruitment of 72 subjects ; and will be conducted at 09 investigator sites in India , with targeted recruitment of 108 subjects from 1st week of July, 2010.

研究设计

研究类型: Interventional
分配方式: Stratified block randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•Patients with type 2 Diabetes Mellitus. 2)Adults between 18 and 75 years of age. 3)Patients with 7% to 11% HbA1c ; 4)Patients who did not take any anti-diabetic agents within 6 weeks prior to the screening. 5)Patients who have signed the consent form after being informed of the objectives, methods, effects, etc. of the study. 6)One of below four conditions. A.Surgically sterile patients; B.Post-menopausal female for at least 2 years who are 45 years or old; C.Pre-menopausal female who agreed to use at least 2 contraceptive methods (one of barrier method must be used) until 14 days after the last treatment of IMPs for birth control (e.g., condom [barrier method], diaphragm [barrier method], oral contraceptive agents, intra-uterine device, depot contraceptives, others); or D.Male patients who agreed to use the recommended proper contraceptive method.
•Any subject who fulfilled the eligibility criteria at Screening Visit will be entered to the placebo run-in period (Visit 2) for 2 weeks after appropriate exercise/diet program.If HbA1c level is out of the inclusion criteria at Screening Visit, the subject may undergo the re-screening test just once.

排除标准

•Patients with Type I Diabetes Mellitus, gestational diabetes, or secondary diabetes.2)Patients who are taking or need to take any drugs which may affect the control of blood glucose significantly ex.
•glucocorticoids).3)Patients who have prior history of myocardial infarction, unstable angina or coronary artery bypass surgery within 6 months prior to screening, or patients with arrhythmia requiring treatment.4)Patients with NYHA (New York Heart Association) Class II, III or IV congestive heart failure.
•Patients with history of hepatic cirrhosis.6)Patients with renal insufficiency or CrCl less than 60 ml /min.
•Abnormal thyroid function (i.e., TSH [thyroid-stimulating hormone] level is out of the normal range).
•Patients with ALT, AST or CPK more than 2.5 times of the upper limit of normal range.9)Patients with BMI less than 20 kg/m2 or more than 40kg/m210)Patients with history of asthma or major skin allergy.11)Patients taking thyroid hormone, warfarin, dicoumarin or digoxin.12)Patients with history of hypersensitivity to metformin or biguanides.13)Patients who have taken sodium channel blockers in the last 6 weeks prior to Visit 1.14)Patients who have been treated with insulin or have taken thiazolidinediones (Glitazone) in the last 6 months prior to Visit 1.15) Any other patients who are not eligible for the study in opinion of the investigator .

结局指标

主要结局

Efficacy Outcome: reduction of HbA1c in test group from baseline compared to the placebo group

时间窗: 24 weeks

次要结局

HbA1C Responder rate at week 24:7% & 6.5%, change of HbA1c and FPG from baseline at week 18.Change of FPG, Serum Insulin, Serum Pro Insulin, Serum c-peptide, HOMA-beta,HOMA IR, from Baseline at Week 24(18 Weeks and 24 Weeks)

研究者

发起方

LG Life Sciences Ltd

申办方类型

Pharmaceutical industry-Global

研究点 (9)

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