| CTRI Number |
CTRI/2010/091/000160 [Registered on: 13/04/2010] |
| Last Modified On: |
05/12/2018 |
| 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 Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease |
Scientific Title of Study
Modification(s)
|
A randomized double blind, placebo-controlled clinical trial to assess the effects of taspoglutide (RO5073031) on cardiovascular outcomes in subjects with inadequately controlled type 2 diabetes and established cardiovascular disease |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NC25113 |
Protocol Number |
| NCT01018173 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shoibal Mukherjee |
| Designation |
Vice President, Medical |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
8th Floor, DLF Square
M Block, Jacaranda Marg
DLF City Phase II
Gurgaon, Haryana
India - 122002
Gurgaon
HARYANA
122002
India |
| Phone |
91-7838652395 |
| Fax |
|
| Email |
shoibal.mukherjee@quintiles.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suchela Srivatsa |
| Designation |
Director – Clinical Operations |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
301-A-1, Leela Business Park
MV Road, Andheri East, Mumbai 400059
Mumbai
MAHARASHTRA
400059
India |
| Phone |
91-9820712114 |
| Fax |
91-22-56774343 |
| Email |
suchela.srivatsa@quintiles.com |
|
Source of Monetary or Material Support
Modification(s)
|
| F. Hoffmann-La Roche Ltd, Switzerland |
|
Primary Sponsor
Modification(s)
|
| Name |
F HoffmannLa Roche Ltd |
| Address |
Grenzacherstrasse 124, CH-4070 Basel,
Switzerland
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Quintiles Research India Private Limited |
B-101-106, Shapath IV, Opp. Karnavati Club, Sarkhej – Gandhinagar Road, Ahmedabad 380 051 |
|
Countries of Recruitment
Modification(s)
|
India
Australia
Brazil
Bulgaria
Canada
Czech Republic
Denmark
Estonia
France
Germany
Hungary
Israel
Italy
Lithuania
Malaysia
Mexico
Poland
Romania
Russian Federation
Slovakia
Spain
Thailand
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 25 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harish Kumar |
Amrita Institute of Medical Sciences & Research Center |
Diabetic Lower Limb and Podiatric Surgery,Amrita Lane, Elamakkara P.O., Edapally-682026
|
91 9052002410
91 (0) 484 2803191
harishkumar@aims.amrita.edu |
| Dr Sreekanth Jaganmani |
Apollo Hospital |
Jubilee Hills,-500033
Hyderabad
ANDHRA PRADESH |
91 (0) 40 23607777
91 (0) 40 23543270
drjsreehanth@gmail.com |
| Dr Ramesh Goyal |
Apollo Hospitals International Ltd |
Block A,Village Bhat, Plot 1A, GIDC Estate-382428
Gandhinagar
GUJARAT |
91 (0) 79 66701802
91 (0) 79 66701843
ramogoyal@yahoo.com |
| Dr Obla Ramachari Kumaran |
Apollo Speciality Hospital |
Lake view road,K.K. Nagar-625020
Madurai
TAMIL NADU |
91 (0) 452 2580894
91 (0) 452 2581157
scrcmdu@yahoo.co.in |
| Dr Manojit Mukhopadhyay |
B.P. Poddar Hospital and Medical Research Ltd |
71/1, Humayun Kabir Sarani New Alipore Block-G,-700053
Kolkata
WEST BENGAL |
91 (0) 33 24458901
91 (0) 33 24577009
mkmukhopadhyay@yahoo.com |
| Dr K. M. Prasanna Kumar |
Bangalore Diabetes Hospital |
16/M, Thimmmayya Road,Vasant Nagar-560052
Bangalore
KARNATAKA |
91 (0) 80 22372980
91 (0) 80 22372981
dr.kmpk@gmail.com |
| Dr Mala Dharmalingam |
Bangalore Endocrinology & Diabetes Research Center |
No. 35, 5th Cross, Malleshwaram Circle, Bangalore – 560003
Bangalore
KARNATAKA |
91-80-65965758
91-80-41281998
bedrc.endo@gmail.com |
| Dr Nadeem Rais |
Chowpatty Medical Centre |
3, Baig Mansion, Babulnath Road,-400007
Mumbai
MAHARASHTRA |
91 (0) 22 23617112
91 (0) 22 23642178
cmctrials@gmail.com |
| Dr Ajay Dande |
Dande Diabetic and Heart Care Centre |
49, Mayanagar ,-431005
Aurangabad
BIHAR |
91 (0) 240 2483456
91 (0) 240 2488332
dr.dande@yahoo.com |
| Dr Vaishali Deshmukh |
Deenanath Mangeshkar Hospital and Research Center |
Erandwane,-411004
Pune
MAHARASHTRA |
91 (0) 20 40151000
91 20 25420104
doc.vaishali@yahoo.co.in |
| Dr Abhay Mutha |
Diabetes Care & Research Centre |
B-5, Mittal Court, 478, Rasta Peth,-411011
Pune
MAHARASHTRA |
91 (0) 20 26124232
91 (0) 20 26124232
drabhaymutha@gmail.com |
| Dr Trichur Viswanathan Devrajan |
Diabetologist Spectra Research Clinical Centre |
5th floor,Apollo Hospitals, -600006
Chennai
TAMIL NADU |
91 (0) 44 28294439
91 (0) 44 28294449
drtvd@rediffmail.com |
| Dr Aravind Sosale |
Diacon Hospital |
359/360, 19th Main, 1st Block,-560010
Bangalore
KARNATAKA |
91 (0) 80 23323560
91 (0) 80 23323560
draravind@hotmail.com |
| Dr Sathyanarayana Srikanta |
Jnana Sanjeevani Medical Centre |
Jnana Sanjeevani Medical Centre No. 2, 1A Cross,,-560078
Bangalore
KARNATAKA |
91 (0) 80 26943040
91 80 26493050
samatvam@vsnl.com |
| Dr Chittaranjan Yajnik |
King Edward Memorial Hospital Research Centre |
6th Floor, Banoocoyaji Building,Sardar Moodliar Road, Rasta Peth, -411011
Pune
MAHARASHTRA |
91 (0) 20 26111958
91 (0) 20 26111958
diabetestrials@yahoo.com |
| Dr Prabha Adhikari |
KMC Hospital |
Attavar,-575001
Bangalore
KARNATAKA |
+91 9880991290
91-824-2425092
dhikari_pmr@yahoo.com |
| Dr Shachin Gupta |
Krishna Diabetes Clinic And Educational Research Centre |
8/2 Sanjay Complex,,-462003
Bhopal
MADHYA PRADESH |
91 (0) 755 2776151
91 (0) 755 2576495
shachinseema@yahoo.com |
| Dr Mohan Vishwanathan |
Madras Diabetes Research Foundation |
Gopalapuram,-600086
Chennai
TAMIL NADU |
91 (0) 44 28459048
91 (0) 44 45510394
mvdsc@vsnl.net |
| Dr Vijay Vishwanathan |
MV Hospital for Diabates & Diabetes Research Centre |
4th, West Mada Church Street, Royapuram,-600013
Chennai
TAMIL NADU |
91 (0) 44 25954913
91 (0) 44 25954919
dr_vijay@vsnl.com |
| Dr Uday Phadke |
Ruby Hall Clinic |
40 Sassoon Road,-411001
Pune
MAHARASHTRA |
91 20 26123391
91 (0) 20 66455605
uday.instride@gmail.com |
| Dr Jugal Bihari Gupta |
S. R. Kalla Memorial General Hospital |
78, Dhuleshwar Garden, C-Scheme,-302001
Jaipur
RAJASTHAN |
91 (0) 141 5112042
91 (0) 141 5112043
guptadrjb@rediffmail.com |
| Dr Nalini Shah |
Seth G.S. Medical College and KEM Hospital |
Acharya Donde Marg,Parel-400012
Mumbai
MAHARASHTRA |
91 (0) 22 24136051
91 (0) 22 24143435
nalinishah@gmail.com |
| Dr Manjusha Mardikar |
Spandan Heart Institute & Research Center |
31, Off Chitale Marg, Behind Hitavada Press,Dhantoli-440012
Nagpur
MAHARASHTRA |
91 (0) 712 2443333
91 (0) 712 2443426
manjushamardikar@gmail.com |
| Dr Ganpathi Bantwal |
St.John?s Medical College and Hospital |
John Nagar,Sarjapur Road-560034
Bangalore
KARNATAKA |
91 80 25633087
91 80 25630603
mallyaganapathi@rediffmail.com |
| Dr Sunil kumar Gupta |
Sunil's Diabetic Care and Research Centre |
42 Lendra Park Ramdas Peth,-440010
Nagpur
MAHARASHTRA |
91 9823152111
91 (0) 712 2428555
guptadrjb@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 25 |
| Name of Committee |
Approval Status |
| BIO COMPATIBLE ETHICS COMMITTEE |
Approved |
| Convinent Hospital Ltd. (CHL) |
Approved |
| Diacon Hospital Ethics Committee, Bangalore-Dr.S.R.Aravind |
Approved |
| EC of Diabetes Care & Research Centre |
Approved |
| EC, Apollo Speciality Hospital,Lake view road,K.K. Nagar-625020,Madurai- Dr. Obla Ramachari Kumaran |
Approved |
| Ethical Committee, Spandan heart Institute & Research Center 31, Off Chitale Marg, Behind Hitavada Press,Dhantoli-440012- Dr. Manjusha Mardikar |
Approved |
| Ethical Committee,B.P. Poddar Hospital and Medical Research Ltd, 71/1, Humayun Kabir Sarani New Alipore Block-G,-700053- Dr Manojit Mukhopadhyay |
Approved |
| Ethical Control Committee, Aurangabad-Dr. Ajay Dande |
Approved |
| Ethics Committee Diabetes Care and Research Center- Dr. Abhay Mutha |
Approved |
| Ethics Committee of Diabetes Research Centre, 42, Lendra Park, Ramdas Peth,-440010- Dr. Sunil Kumar Gupta |
Approved |
| Ethics Committee on Human Research, Bangalore Endocrinology & Diabetes Research Center, Banagalore- Dr Mala Dharmalingam |
Approved |
| Ethics Committee, Apollo Hospitals International Limited- Dr. Ramesh Goyal |
Approved |
| Ethics Committee, Diabetes Research Center. Chennai- Dr Vijay Vishwanathan |
Approved |
| Ethics Review Board, Chowpatty Medical Centre, 3, Baig Mansion, Babulnath Road, Mumbai-400007 - Dr. Nadeem Rais |
Approved |
| Global Health Concern Ethics Committee |
Approved |
| IEC, Amrita Institute of Medical Sciences |
Submittted/Under Review |
| Independent Ethics Committee of Krishna Diabetes Clinic & Educational Research Centre, 8/2 Sanjay Complex, Bhopal-462003- Dr. Shachin Gupta |
Approved |
| Institutional Ethical Review Board, Ground Floor, St.Johns Medical College, Bangalore-Dr. Ganapati Bantawal |
Approved |
| Institutional Ethics Committee - Poona Medical Research Foundation- Dr. Uday Keshav Phadke |
Approved |
| Institutional Ethics Committee of Madras Diabetes Research Foundation, Chennai - Dr. V Moahn |
Approved |
| K. E. M. Hospital Research Centre Ethics Committee, Sardar Mudliyar Road, Rasta Peth, Pune- Dr. Chittaranjan Yajnik |
Approved |
| Local Ethics Committee-Apollo Hospital |
Submittted/Under Review |
| Manipal University Ethics Committee- Dr. Prabha Adhikari |
Approved |
| S.R.Kalla Memorial Ethical Committee For Human Research, Jaipur- Dr. J.B.Gupta |
Approved |
| SCIENCE FOR HEALTH, c/o Jnana Sanjeevini Medical Center, # 2, 1A Cross, Marenahalli, J.P. Nagat, 2nd Phase, Banagalore- 560078- Dr. Sathyanarayana Srikanta |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Diabetes Mellitus, Type 2, (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Comparator |
sc weekly |
| Intervention |
Taspoglutide |
10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
adult patients, more than 18 years of age
diabetes mellitus type 2
HbA1c more than or equal to 6.5% and less than or equal to 10% at screening
BMI more than or equal to 23kg/m2
cardiovascular disease with onset more than or equal to month prior to screening
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
diagnosis or history of type 1 diabetes or secondary forms of diabetes
acute metabolic diabetic complications within past 6 months
severe hypoglycemia </=1 month prior to screening
clinically significant gastrointestinal disease
history of chronic or acute pancreatitis
current NYHA class IV heart failure or post-transplantation cardiomyopathy
severely impaired renal function
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Time to first occurrence of any component of a cardiovascular composite endpoint (CV death, MI, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or hospitalization for heart failure) |
Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Secondary cardiovascular composite endpoints,Individual components of primary cardiovascular composite endpoints, Total mortality,Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, ACR, albuminuria, GFR |
weeks 1,4,12 and every 3 to 4 months thereafter |
|
Target Sample Size
Modification(s)
|
Total Sample Size="2000"
Sample Size from India="350"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
25/05/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/04/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and safety and the effects of taspoglutide on cardiovascular events in patients with inadequately controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or weekly sc placebo, in addition to background anti-hyperglycemic medication and standard of care treatment for cardiovascular disease. Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients globally and 350 patients from India. The anticipated date of enrollment for the Indian arm is April 15, 2010. |