A clinical trial to evaluate the efficacy and safety of LC15 - 0444 in patients with type II diabetes

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: LC 15 ‐ 0444: 50 mg OD for 24 weeks Control Intervention1: Placebo: 24 weeks CONDITION: Type 2 Diabetes Mellitus PRIMARY OUTCOME: Efficacy Outcome: reduction of HbA1c in test group from baseline compared to the placebo group‐‐‐‐‐‐Timepoint: 24 weeks SECONDARY OUTCOME: 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‐‐‐‐‐‐Timepoint: 18 Weeks and 24 Weeks INCLUSION CRITERIA: 1)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 w
Epistemonikos ID: a93040f256d8e382e90ecbcc737378a03d0d2649
First added on: Aug 22, 2024