| CTRI Number |
CTRI/2009/091/000636 [Registered on: 24/09/2009] |
| 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
Modification(s)
|
Dose Finding, Safety and Effectiveness of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients |
|
Scientific Title of Study
|
Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration for the Treatment of Hyperglycemia in Metformin Monotherapy Treated Type 2 Diabetic Patients: a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACZ885I2202 |
Protocol Number |
| NCT00900146 |
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
Modification(s)
|
| Name |
K Murugananthan |
| 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 |
022-24958545 |
| Fax |
022-24954112 |
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
K Murugananthan |
| 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 |
022-24958545 |
| Fax |
022-24954112 |
| Email |
murugananthan.k@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
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harish Kumar |
Amrita Institute of Medical Sciences |
Research Division,Dept of Endocrinology & Diabetes,Amrita Lane, Elamakkara.
|
0484-2801234
0484-2802131
harishkumar@aims.amrita.edu |
| Dr Sanjay Reddy |
Bangalore Diabetes Hospital |
16/M, Thimmaiah Road,Millers Tank Bed Area, Vasanthnagar
Bangalore
KARNATAKA |
91-9886241898
8022372981
drsanjaycreddy@yahoo.com |
| Dr Sunil M Jain |
Diabetes Thyroid Hormone Research Institute |
11/5, New Palasia ,(After Chhappan Dukan Triangle, On Right Side.
Indore
MADHYA PRADESH |
9826012966
0731-2541250
sunilmjain@gmail.com |
| Dr KM Prasanna Kumar |
Gokula Metropolis Clinical Research Centre |
M.S. Ramaiah Memorial hospital, Endocrinology dept,M.S.R.I.T, post ,new bel road
Bangalore
KARNATAKA |
0-9845156811
080-22183030
dr.kmpk@gmail.com |
| Dr Mathew Thomas |
Health and Research Centre |
TC - 1 / 907 , 1st floor,Devi Scans Building,Kumarapuram Medical college
|
91-471-2447575
91-0471-2554913
healthtrials@gmail.com |
| Dr S S Srikanta |
Jnana Sanjeevini Medical Center |
No. 2.1 A Cross, Marenahalli,J P Nagar Phase 2
Bangalore
KARNATAKA |
9886042322
91-80-26764017
samatvam@vsnl.com |
| Dr K A V Subrahmanyam |
King George Hospital |
Andhra Medical College
Visakhapatnam
ANDHRA PRADESH |
9848149536
0891-2508275
kavsendo@yahoo.co.in |
| Dr V Mohan |
Madras Diabetes Research Foundation |
No:4 Conran Smith Road,Gopalapuram
Chennai
TAMIL NADU |
91-44-43968888
91-44-28350935
drmohans@gmail.com |
| Dr Usha Rani |
Nizam?s institute of Medical Sciences |
Dept of pharmacology and therapeutics,Punjagutta
Hyderabad
ANDHRA PRADESH |
0-9849574143
040-23357238
ushapingali@yahoo.com |
| Dr Shailesh Pitale |
Pitale Diabetes & Hormone centre |
Shriman Complex,Ground Floor
Nagpur
MAHARASHTRA |
0-9822225631
drpitale@yahoo.co.in |
| Dr J B Gupta |
S.R Kalla Memorial Hospital |
78, Dhuleshwar Garden,C-Scheme
Jaipur
RAJASTHAN |
91-9829414680
91-141-4020622
guptadrjb@rediffmail.com |
| Dr Sharda A |
Samatvam: Endocrinology Diabetes Centre |
640, I Main, I Stage,Indiranagar
Bangalore
KARNATAKA |
0-9448063156
sharda.a@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Bangalore Diabetes Hospital Ethics Committee, Bangalore Diabetes Hospital |
Approved |
| Ethical Review Board, M.S. Ramiah Medical College and Teaching Hospital |
Approved |
| Ethics Committee of Diabetes Thyroid Hormone Research Institute Pvt. Ltd |
Approved |
| Independent Ethics Committee Science For Health, Jnana Sanjeevini |
Submittted/Under Review |
| Independent Ethics Committee Science For Health, Jnana Sanjeevini (for Samatvam Endocrinology Diabetes Centre) |
Approved |
| Independent Ethics Committee- Nagpur |
Approved |
| Independent Human Ethics Committee, Health And Research Centre |
Approved |
| Institutional Ethics Committee of Madras Diabetes Research Foundation |
Approved |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, King George Hospital |
Approved |
| Institutional Ethics Committee, Nizam's Institute of Medical Sciences |
Approved |
| S.R. Kalla Memorial Ethical Committee for Human Research |
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 |
Canakinumab |
Drug: Canakinumab
Canakinumab lyophilized cake (25 mg and 150 mg in individual 6 mL glass vials ) was reconstituted and then used to dilute the 25mg or 150mg solutions to make 5mg, 15mg and 50mg injections.
Drug: Metformin
Before randomization, in drug naïve patients at a dose of 1000 mg with the evening meal or 500 mg b.i.d. (twice daily) with two main meals. At the randomization visit, patients were prescribed with no less than 1,000mg/day |
| Comparator Agent |
Placebo Comparator |
Placebo Comparator: Placebo + Metformin
In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1.Patients must have a documented diagnosis of Type 2 diabetes confirmed by WHO criteria either a FPG greater than or equal to 7.0 mmol/l (126 mg/dl) or an OGTT test 2-hour PG greater than or equal to 11.1 mmol/l (200 mg/dl).
2.Patients must:
* be naïve to anti-diabetes drug therapy (except for short term treatment courses with insulin in connection with hospitalization, etc.)
* meet protocol specified HBA1C criteria
* be eligible for metformin monotherapy OR
* be on stable metformin monotherapy treatment for at least three months at Screening
* meet protocol specified HBA1C criteria
* take metformin as their first and only treatment with anti-diabetes drug therapy
3. Patients must have a morning fasting plasma glucose result < 180 mg/dl at Visit 3 (Month -1) analyzed by the Central Laboratory. |
|
| ExclusionCriteria |
| Details |
1. Any of the following significant laboratory abnormalities:
* Serum GAD-antibody positivity
* Clinically significant TSH outside of normal range at Screening
* Renal function indicating high risk metformin use, including serum creatinine concentrations (>=1.5 mg/dL for males,>=1.4 mg/dL for females) or other evidence of abnormal creatinine clearance.
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Screening, confirmed with repeat measure within one week.
2.History or current findings of active pulmonary disease
3.Risk factors for TB as defined in protocol
4.Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment.
5. Stroke, myocardial infarction, acute coronary syndrome, revascularization procedure or recurrent TIA within the last 6 months.
6. Unwillingness to use insulin glargine as the additional medication should glycemic control deteriorate. Other protocol-defined inclusion/exclusion criteria may apply.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess safety and tolerability of four doses of ACZ885 vs. placebo over 4 months in patients with T2DM To assess the effect on HbA1c of four doses of ACZ885 vs. placebo as an add-on regimen over 4 months in patients with T2DM |
Time Frame: 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of 4-month treatment of ACZ885 at 4 doses vs. placebo on the following variables: ? Glucose, C-peptide and insulin following meal test ? 7-point glucose meter data ? hsCRP |
Time Frame: 4 months |
| To evaluate the effect of 4-month treatment of ACZ885 vs. placebo on cardiovascular events and infections. |
Time Frame: 4 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="555"
Sample Size from India="119"
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/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
13/11/2009 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/04/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Target number of patients from India is 80.
The expected recruitment from India is on 5th Nov 2009. |