A clinical trial to evaluate the efficacy and safety of LC15 - 0444 in patients with type II diabetes.
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2010/091/000353
- Lead Sponsor
- G Life Sciences Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
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 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.
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 40kg/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 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 .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Outcome: reduction of HbA1c in test group from baseline compared to the placebo groupTimepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method 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 24Timepoint: 18 Weeks and 24 Weeks