Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: LC15-0444: 25mg twice a day/ 50 mg once a day for 24 weeks
Control Intervention1: sitagliptin: 100 mg once a day for 24 weeks
Sponsors
LG Life Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients with type 2 Diabetes Mellitus. 2)Adults between 18 and 75 of age. 3)Patients with 7% to 11% HbA1c ; 4)Patients who have been treated with Metformin monotherapy for 12 weeks or longer and who have taken Metformin at 1,000 mg/day or more for not less than 4 weeks. 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.
Exclusion criteria
Exclusion criteria: 1) 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. 5) Patients with history of hepatic cirrhosis. 6) Patients with renal insufficiency or CrCl less than 60 ml/min. 7) Abnormal thyroid function (i.e., TSH [thyroid-stimulating hormone] level is out of the normal range). 8) 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 40 kg/m2 . 10) 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 with history of hypersensitivity to Pioglitazone or Thiazolidinediones. 14) Patients who have taken sodium channel blockers in the last 6 weeks prior to Visit 1. 15) Patients who have been treated with insulin or have taken Thiazolidinediones (Glitazone) in the last 6 months prior to Visit 1. 16) Any other patients who are not eligible for the study in the investigators opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Endpoint: Change of HbAlc from baseline, at Week 24. Safety Endpoint:Adverse Events, Vital Signs & Laboratory Tests. Timepoint: 24 weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| A. HbA1c Responder rate at week 24: HbA1c 7% to 6.5% B. Change of HbA1c & FPG from baseline at week 18 C. Change of FPG, Serum insulin, Serum pro insulin, serum peptide, HOMA B & HOMA IR at week 24 Timepoint: Value at Week 18 & 24 from Baseline value | — |
Countries
Democratic People's Republic of Korea, India
Contacts
Public ContactDr Deepali Mittal
Project Physician
Outcome results
None listed