| CTRI Number |
CTRI/2010/091/000353 [Registered on: 01/07/2010] |
| Last Modified On: |
28/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to evaluate the efficacy and safety of LC15 - 0444 in patients with type II diabetes. |
Scientific Title of Study
Modification(s)
|
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. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| LG-DPCL-005 |
Protocol Number |
| U1111-1113-1695 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrMita Nandy |
| Designation |
|
| Affiliation |
|
| Address |
LG House, Plot # 11
Sector - 44
Gurgaon
HARYANA
122 001
India |
| Phone |
0124-4830000 |
| Fax |
0124-4001146 |
| Email |
mita.nandy@lglsi.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrMita Nandy |
| Designation |
|
| Affiliation |
Project Physician |
| Address |
LG House, Plot # 11
Sector - 44
Gurgaon
HARYANA
122 001
India |
| Phone |
0124-4830000 |
| Fax |
0124-4001146 |
| Email |
mita.nandy@lglsi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Deepali Mittal |
| Designation |
|
| Affiliation |
|
| Address |
LG House, Plot # 11
Sector - 44
Gurgaon
HARYANA
122 001
India |
| Phone |
0124-4830000 |
| Fax |
0124-4001146 |
| Email |
deepali.mittal@lglsi.com |
|
Source of Monetary or Material Support
Modification(s)
|
| LG Life Sciences Ltd,
20 Yoido-dong, Youngdungpo-gu
Seoul 150-721
Korea
|
|
Primary Sponsor
Modification(s)
|
| Name |
LG Life Sciences Ltd |
| Address |
20 Yoido-dong, Youngdungpo-gu.Seoul 150-721
Korea |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Democratic People's Republic of Korea |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Mala Dharmalingam |
Bangalore Endocrinology and Diabetes Research Centre, |
#33/1, 1st floor, Margosa Road,Btwn 12th & 13th Cross, Malleswaram-560 003
Bangalore
KARNATAKA |
+91- 80- 65965758
+91- 80- 41281998
bedrc..endo@gmail.com |
| Dr. Aravind Sosale |
Diacon Hospital, Diabetes Care & Research Center, |
359/360, 19th Main,1st Block,Rajajinagar,-560 010
Bangalore
KARNATAKA |
+91-80-23131166
+91-80-23130553
diacon90@hotmail.com |
| Dr. Pramod Gandhi |
Gandhi Research Institute, |
C1, Shreewardhan Complex, ,Ramdaspeth, Wardha Road, -440 010
Nagpur
MAHARASHTRA |
+91-712-2460302
drpdgandhi1@yahoo.co.in |
| DrPankaj Kumar Agarwal |
Hormone Care and Research Centre |
SB-5, Shastri Nagar,-201 002
Ghaziabad
UTTAR PRADESH |
91-120-2780473
hormonecareghaziabad@rediffmail.com |
| Dr.Sandeep Kumar Gupta |
M.V.Hospital and Research Centre, |
314/30, Mirza Mandi Chowk,-
|
+91- 522- 3238446
+91- 522- 4016051
sandeepkumar.gupta@rediffmail.com |
| Dr. Uma Mahesh |
M.V.Hospital for Diabetes (P) Ltd., |
4, West Mada Church Street ,Royapuram, -600 013
Chennai
TAMIL NADU |
+91- 44- 25954913
+91- 44- 25954919
maheshkandikattu@gmail.com |
| Dr. V. Mohan |
Madras Diabetes Research Foundation |
#4, Conran Smith Road, ,Gopalapuram-600086
Chennai
TAMIL NADU |
+91- 44- 43968888.
+91-44- 28350935
drmohans@vsnl.net |
| Dr. Shailesh Pitale |
Pitale Diabetes and Hormone Center |
Ground Floor , Shriman Complex,Near Lokmat Square, Dhantoli, -440 012
Nagpur
MAHARASHTRA |
+91-712-2457176
+91-712-2420456
dr.pitale@yahoo.co.in |
| Dr. Vyankatesh K.Shivane |
RHIDEM (Research Health Institute in Diabetes, Endocrinology & Metabolism) |
1/15, Rupal Apartment, 3rd Floor,98 Dadasaheb Phalke Road, Opposite Aroma Restaurant, Dadar (E)-400 014
Mumbai
MAHARASHTRA |
+91-22-24171042
+91-22-4153525
drvkshivane@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| BEDRC Ethics Committee on Human Research, Bangalore Endocrinology & Research centre, # 35, 5th Cross, Malleshwaram Circle, Bangalore - 560 003 |
Approved |
| Central India Medical Research Ethics Committee, Gandhi Research Institute, Shreevardhan Complex, Wardha Road, Ramdaspeth, Nagpur (MS)-440010 |
Approved |
| Diacon Hospital Ethics Committee, Diacon Hospital Diabets Care & Researh Centre, 359/60, 19th Main 1st Block, Rajaji Nagar, Bangalore - 560 010 |
Approved |
| Ethics Committee, Diabetes Research Centre, 4, West Madha Church Street, Royapuram, Chennai-600 013 |
Approved |
| Independent Ethics Committee, Dept. of Clinical Pharmacology, TNMC & BYL Nair Charitable Hospital, Dr. A. L. Road, Mumbai Central, Mumbai-400 008 |
Approved |
| Independent Ethics Committee, Nagpur, REGD. OFFICE: Getwell Hospital & Research Institute, 20/1, Behind Vijayanand Society, Dhantoli, Nagpur - 440012 |
Approved |
| Instituitional Ethics Committee, Madras Diabetes Research Foundation, REGD. OFFICE: No. 4, Conran Smith Road, Gopalapuram, Chennai- 600 086 |
Approved |
| Instituitional Ethics Committee, 314/30, Mirza Mandi Chowk, Lucknow, U P- 226003 |
Approved |
| Institutional Ethics Committee of Hormone Care and Research Center, SB-5, Shastri Nagar, Ghaziabad, U P-201 002 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
LC 15 - 0444 |
50 mg OD for 24 weeks |
| Comparator Agent |
Placebo |
24 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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 . |
|
Method of Generating Random Sequence
Modification(s)
|
Stratified block randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Efficacy Outcome: reduction of HbA1c in test group from baseline compared to the placebo group |
24 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 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 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="180"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
13/07/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
03/01/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |