| CTRI Number |
CTRI/2010/091/000151 [Registered on: 15/04/2010] |
| Last Modified On: |
11/09/2014 |
| 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
|
To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies |
|
Scientific Title of Study
|
A Multi-center, Double-blind, Placebo-controlled, Randomized Study to Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes Treated With Differing Baseline Diabetes Therapies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACZ885I2207 |
Protocol Number |
| NCT01068860 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kamala Rai |
| Designation |
|
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited, Medical Department,
Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022 -24958533 |
| Fax |
022 -24954112 |
| Email |
kamala.rai@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kamala Rai |
| Designation |
|
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited, Medical Department,
Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022 -24958533 |
| Fax |
022 -24954112 |
| Email |
kamala.rai@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Basel, Switzerland |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Healthcare Private Limited |
| Address |
Sandoz House, 5th floor
Shivsagar Estate
Dr. Annie Besant Road
Worli, Mumbai 400 018
INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. KAV Subrahmanyam |
Visakha Diabetes & Endocrine Centre |
M.V.V.chambers,Near K.G.H. OP GATE,MAHARANIPETA-530002
Visakhapatnam
ANDHRA PRADESH |
91-9848149536
0891- 2711879
kavsendo@yahoo.co.in |
| Dr. Sanjay Reddy |
Bangalore Diabetes Hospital |
16/M, Thimmaiah Road,,Millers Tank Bed Area,Vasanthnagar-560052
Bangalore
KARNATAKA |
91-9886241898
080-22372981
drsanjaycreddy@yahoo.com |
| Dr. Shailaja Kale |
Centre of Excellence for Diabetics |
Sahyadri Hospital Bibewewadi, Plot nO.13 ,S.No. 573 City No.281 ,Swami Vivekanand Marg ,Bibwewadi -411037
Pune
MAHARASHTRA |
91 020 67213722
91 020 67213722
drshailaja@yahoo.com |
| Dr. Sunil M Jain |
Diabetes Thyroid Hormone Research Institute Pvt .Ltd. |
11/5, New Palasia (After Chhappan Dukan Triangle, On Right Side),,-452001
Indore
MADHYA PRADESH |
91-9826012966
0731-2541250
sunilmjain@gmail.com |
| Dr. Rajendran Nair |
Health & Research Centre |
TC-1/907,1st Floor,Devi Scan Building,Kumarapuram,Medical College,P.O-695011
|
91 9447058561
91 471 2554913
rajendranammu@yahoo.com |
| Dr. Aarti Dharaskar |
Indrayani Speciality Hospital |
156,Eshwar Smruti (Neelgiri) ,ramdaspeth-440010
Nagpur
MAHARASHTRA |
91-9823154927
indrayanihop@yahoo.co.in |
| Dr. S S Srikanta |
Jnana Sanjeevini Medical Center |
No. 2.1 A Cross, Marenahalli,,JP Nagar Phase 2,-560078
Bangalore
KARNATAKA |
91-9886042322
080-26764017
jsmcindia@gmail.com |
| Dr. V Mohan |
Madras Diabetes Research Foundation |
No:4 Conran Smith Road,,Gopalapuram-600086
Chennai
TAMIL NADU |
91-44-43968888
91-44-28350935
drmohans@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Bangalore Diabetes Hospital Ethics Committee |
Approved |
| Central India Medical Research Ethics Committee, Nagpur |
Approved |
| Ethics Committee of Diabetics Thyroid Hormone Research Institute Pvt Ltd |
Approved |
| Ethics Committee Sahyadri Speciality Hospital |
Approved |
| Independent Human Ethics Committee, Health & Research Centre |
Approved |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
| Institutional Ethics Committee, King George Hospital |
Approved |
| Science for Health, Jnana Sanjeevini Medical Center |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Diabetes Mellitus Type 2
Impaired Glucose Tolerance
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
canakinumab Dose 1: Experimental |
Drug: canakinumab + background diabetes therapy |
| Comparator Agent |
Placebo: Experimental |
Drug: placebo + background diabetes therapy |
|
Inclusion Criteria
Modification(s)
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Patient must fulfill all criteria in one of the following groups:
* Impaired Glucose Tolerance (IGT) as diagnosed per protocol and not on an anti-diabetic medicine during the study
* Diagnosis of Type 2 diabetes in stable treatment with metformin
* Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day) in combination with a sulfonylurea
* Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day), sulfonylurea and thiazolidinedione combination therapy
* Diagnosis of Type 2 diabetes in stable treatment with at least two insulin injections a day with or without metformin
2. HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to the IGT group
3. Age from 18-74 years, inclusive, and of either sex
|
|
| ExclusionCriteria |
| Details |
1. Type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary forms of diabetes
2. History or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as defined in the protocol:
3. Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate canakinumab effects on change from baseline of meal challenge derived insulin secretion rate relative to glucose at 4 weeks for each population |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| * Evaluate the effect on change from baseline of other meal challenge derived parameters, including insulin, glucose and other glycemic control parameters |
4 weeks |
| * Provide information on canakinumab effects on improving glucose parameters in people with impaired glucose tolerance |
4 weeks |
| * Assess safety and tolerability for all study populations |
4 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="244"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Planned number of patients from India is 60.
Planned FPFV is 21st April 2010. |