| CTRI Number |
CTRI/2010/091/000012 [Registered on: 29/01/2010] |
| Last Modified On: |
12/12/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to assess the efficacy and safety of recombinant insulin glargine compared with Lantus® in patients with Type II Diabetes Mellitus uncontrolled on OAD Therapy. |
Scientific Title of Study
Modification(s)
|
A prospective, multicentre, comparative, open label, randomised parallel phase III study to assess efficacy and safety of recombinant insulin glargine compared with Lantus® in patients with Type II Diabetes Mellitus uncontrolled on OAD therapy. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| IG-09-02 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Deepali Mittal |
| Designation |
Deputy General Manager |
| Affiliation |
Project Leader |
| Address |
Plot no 11,
Sector 44
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
deepali.mittal@lglsi.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Mita Nandy |
| Designation |
Senior Vice President |
| Affiliation |
Project Physician |
| Address |
LG House Plot No. 11
Sector - 44
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4830000 |
| Fax |
0124-4001146-48 |
| Email |
mita.nandy@lglsi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Deepali Mittal |
| Designation |
Deputy General Manager |
| Affiliation |
Project Leader |
| Address |
LG House Plot No. 11
Sector-44
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4830000 |
| Fax |
0124-4001146-48 |
| Email |
deepali.mittal@lglsi.com |
|
Source of Monetary or Material Support
Modification(s)
|
| LG Life Sciences India Pvt Ltd |
|
Primary Sponsor
Modification(s)
|
| Name |
LG Life Sciences India Pvt Ltd |
| Address |
LG House Plot No. 11
Sector-44
Gurgaon
Haryana-122001
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Sandeep Julka |
CHL - Apollo Hospitals, Indore |
CHL - Apollo Hospitals, Opp. Anoop Nagar, ,Near LIG Triangle, AB Road,-452008
Indore
MADHYA PRADESH |
0731-2549090/4072550-
0731-4245625
sandeep_julka@yahoo.com |
| Dr. Jubbin Jagan Jacob |
Christian Medical College, Ludhiana |
Endocrine and Diabetes Unit,,Department of Medicine,Christian Medical College,-161008
Ludhiana
PUNJAB |
0161-5026999 Ext.: 5022/4817
0161-2600270/2609958
jubbin.jacob@gmail.com |
| Dr. Subhash B Yadav |
Department of Endocrinology, Sanjay Gandhi Post Graduate Institute of Medical Sciences |
C-Block, Department of Endocrinology,,Sanjay Gandhi Post Graduate Institute of Medical Sciences,-226014
Lucknow
UTTAR PRADESH |
0522-2668004
0522-2668017
subhash70@gmail.com |
| Dr. Sharad Pendsey |
Diabetes Clinic & Research Centre,Nagpur |
"ShreeNiwas, Opp. Dhantoli Park,,Nagpur-440012
Nagpur
MAHARASHTRA |
0171-2521898
0712-2545989
sharad_ngp@sancharnet.in |
| Dr. Surendra Kumar Sharma |
Diabetes, Thyroid and Endocrine Centre, Jaipur |
11, Shivaji Nagar,,Civil Lines-302006
Jaipur
RAJASTHAN |
0141-2229202
0141-2221598
sksharma7@gmail.com |
| Dr. Pankaj Kumar Agarwal |
Hormone Care & Research Centre, Ghaziabad |
SB-5, Near St. Mary's School,Ghaziabad-201002
Ghaziabad
UTTAR PRADESH |
0120-2780473/2754801
0120-4126147
hormonecareghaziabad@rediffmail.com |
| Dr. Puneet Rijhwani |
Mahatma Gandhi Medical College & Hospital |
RIICO Institutional Area,Sitapura-302022
Jaipur
RAJASTHAN |
0141-2551388
puneet284@rediffmail.com |
| Dr. Sandeep Kumar Gupta |
MV Hospital & Research Centre,Lucknow |
314/30, Mirza Mandi Chowk,,Lucknow-226003
Lucknow
UTTAR PRADESH |
0522-3238446
0522-4016051
sandeepkumar.gupta@rediffmail.com |
| Dr. Rajeev Chawla |
North Delhi Diabetes Centre, Delhi |
, 180, Jai Apartments,,Sector-9, Rohini,-110085
New Delhi
DELHI |
011-27562031/-27563814
011-47045282
rajeevaastikchawla@yahoo.com |
| Dr. Jugal Bihari Gupta |
SR Kalla Memorial Gastro & General Hospital, Jaipur |
78, Dhuleshwar Garden, ,Behind HSBC Bank, Sardar Patel Marg, C-Scheme-302001
Jaipur
RAJASTHAN |
0141-5112042
0141-4020622/2378914/15
guptadrjb@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| CHL-Apollo Hospitals - Ethics Committee, |
Approved |
| Human Welfare Ethical Committee for Human Sciences and Research, Jaipur |
Approved |
| Institutional Ethics Committee for Human Research, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow |
Approved |
| Institutional Ethics Committee for Mahatma Gandhi Medical College & Hospital, Jaipur |
Approved |
| Institutional Ethics Committee for MV Hospital and Research Centre, Lucknow. |
Approved |
| Institutional Ethics Committee of Hormone Care and Research Centre, Ghaziabad. |
Approved |
| SPECT-ERB,New Delhi. |
Approved |
| SR Kalla Memorial Ethical Committee for Human Research,,Jaipur. |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type II Diabetes Mellitus uncontrolled on Oral Anti Diabetic Therapy, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Lantus ® |
Starting at an average dose of 10 IU once daily of Lantus® Sub-Cutaneous injection,before sleep along
with oral agents continued at pre study doses. The dose of Lantus® needs to be adjusted
till the Fasting Blood Glucose value is less than or equal to 120 mg/dl is achieved, (adjusted every 3 days by 2U)upto a maximum dose of 100 IU. |
| Intervention |
Recombinant Insulin Glargine |
Starting Dose
is 10 IU once daily subcutaneously
before sleep
along with
oral antidiabetic. The dose of recombinant insulin glargine needs to be adjusted till the Fasting Blood Glucose value is
lower than or equal to
120 Mg/Dl is
achieved, (adjusted every 3 days by 2U) upto a maximum dose of 100 IU)
Dosing starts at an average dose of 10 IU once daily of Insulin Glargine subcutaneous injection (in the abdomen or thigh)before sleep along with oral agents continued at pre-study doses The dose of Insulin Glargine needs to be adjusted till the Fasting Blood Glucose
value is lower than or equal to 120 mg/dl is achieved, (adjusted every 3 days by 2 U ) upto a maximum dose of 100 IU |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients are eligible for participation into the study if all of the following criteria are met:
· Insulin naïve male or female type II diabetes mellitus patient
· Age between 18 and 75 years.
· At least 12 months history of Type II Diabetes
· Inadequate glycemic control on stable doses of one or more
oral antidiabetics for more tah or equal to 3 months
· HbA1c between 7.5 to 10 %.
· FBG more than or equal to 126 mg/dl, and less than 234 mg/dl.
· Body Mass Index less than or equal to 40 kg/m2
· Willing and able to measure Fasting Blood Glucose by blood
glucose meter and 8-time point blood glucose within 24
hours, once before every visit.
· Willing and able to give informed consent and comply with
study procedures. |
|
| ExclusionCriteria |
| Details |
. Type I Diabetes Mellitus
· Prior use of insulin except for gestational diabetes or for less
than or equal to 1 week
· Pancreatitis or Pancreatectomy
· History of ketoacidosis
· Clinically relevant cardiovascular, hepatic, neurological,
endocrine, gastrointestinal, urinary,reproductive or other major
systemic diseases
· Impaired renal function with serum creatinine greater than or
equal to 1.5 mg/dl
· Impaired hepatic function as shown by ALT or AST greater than
twice the upper limit of normal
· Proliferative diabetic retinopathy.
· Use of other agents affecting glycemic control (non-selective
beta- blockers, weight loss agents.)
· History of myocardial infarction
· Female patient who is pregnant, wishes to become pregnant
during study period, or is breastfeeding.
. Recent history (within 60 days) or likely future use of systemic
glucocorticosteroids or other immunosuppressant or cytotoxic
therapy.
· Self reported inability to recognize hypoglycemia
· Being a night shift worker
· Participation/Treatment with any investigational drug or biologic
in a clinical study within the past 30 days.
· History of drug or alcohol abuse.
· Any other condition which, in the judgment of the investigator,
makes the patient unsuitable to participate in the study. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Efficacy: Change in HbA1c from
baseline to treatment period. |
Efficacy: 24 Weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Efficacy:Mean blood glucose in two treatment groups (8 time-point BG value per 24 hrs) |
24 Weeks treatment period |
| Change in FBG from baseline to endpoint in the two treatment groups. |
24 weeks treatment period |
| Hypoglycemic incidence rate in the two treatment groups |
24 weeks treatment period |
|
Target Sample Size
Modification(s)
|
Total Sample Size="278"
Sample Size from India="278"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
10/03/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a prospective, multicentre, comparative, open label, randomised parallel phase III clinical study with primary objective to assess efficacy and safety of recombinant insulin glargine compared with Lantus® in patients with Type II Diabetes Mellitus uncontrolled on Oral Anti-Diabetic therapy, that will be conducted in nine investigator sites in India.The secondary outcome will be To compare test drug and Lantus® with respect to the (a) Glycemic control as determined by self monitored blood glucose concentrations (b) Change from baseline to endpoint in fasting blood glucose; and (c) Incidence of Hypoglycemia |