| CTRI Number |
CTRI/2008/091/000071 [Registered on: 15/07/2008] |
| Last Modified On: |
30/10/2018 |
| 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 clinical trial to study the efficacy and safety of AVE0010 in patients with type 2 diabetes not treated with antidiabetic agents |
Scientific Title of Study
Modification(s)
|
A randomized, double-blind, placebo-controlled, parallel-group, multicenter 12-week study assessing the
efficacy and safety of AVE0010 in patients with type 2 diabetes not treated with antidiabetic agents |
| Trial Acronym |
GETGOAL MONO |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EFC6018 |
Protocol Number |
| NCT00688701 |
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 |
Vaishali Kanade |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi-Synthelabo (India) Limited |
| Address |
Sanofi Synthelabo, 54/A, Sir Mathuradas Vasanji Road, Andheri(East), Mumbai-400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02230707823 |
| Fax |
|
| Email |
vaishali.kanade@sanofi-aventis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Vaishali Kanade |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi-Synthelabo (India) Limited |
| Address |
Sanofi Synthelabo, 54/A, Sir Mathuradas Vasanji Road, Andheri(East), Mumbai-400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
02230707823 |
| Fax |
|
| Email |
vaishali.kanade@sanofi-aventis.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Sanofi Synthelabo.
54/A, Sir Mathuradas Vasanji Road
Andheri(E), Mumbai-400093, India.
|
|
Primary Sponsor
Modification(s)
|
| Name |
Sanofi Synthelabo India Limited |
| Address |
54/A, Sir Mathuradas Vasanji Road Andheri(E), Mumbai-400093, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Belgium
Israel
Japan
Mexico
Poland
Republic of Korea
Romania
Russian Federation
Tunisia
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mala Dharmalingam |
Bhagwan Mahaveer Jain Hospital |
Miller’s Road, Vasanth Nagar, Bangalore-560052
Karnataka, India
Bangalore
KARNATAKA |
9739366356
mala_endo@rediffmail.com |
| Dr. Sunil Jain |
Diabetes Thyroid Research Institute Pvt Ltd |
,-
|
sunilmjain@gmail.com |
| Dr. Mohan Badgandi |
Manipal Hospital |
,-
Bangalore
KARNATAKA |
mohan.badgandi@manipalhealth.com |
| Dr. Banshi Saboo |
Medilink Research Centre |
,-
|
banshisaboo@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| BMJH Ethics Committee On Human Research |
Submittted/Under Review |
| Ethics Committee of Diabetes Thyroid Hormone Research Institute Pvt Ltd, Indore |
Approved |
| Ethics Committee of Manipal Hospital and Manipal Heart Foundation |
Approved |
| Medilink Independent Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes for Glycemic Control and Safety Evaluation , (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
AVE0010 |
Two Step arm:-
-10μg(1stweek)
-15μg(2ndweek)
-20μg(for remaining 10 weeks)
One Step arm:-
-10μg for the 1st 2 weeks.
-20μg for the remaining 10 weeks. |
| Comparator Agent |
Volume-matched placebo |
Two step arm:
10 μg for the 1st week
15 μg for the 2nd week
20 μg for the remaining 10 weeks
One step arm:
10 μg for the 1st 2 weeks
20 μg for the remaining 10 weeks
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes mellitus not treated with any antidiabetic agent |
|
| ExclusionCriteria |
| Details |
(1) HbA1c < 7% or > 10%
(2) Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
(3) Type 2 diabetes treated by an antidiabetic agent within the 3 months preceding the study
(4) Body mass index < 20 kg/m2
(5) Weight change of more than 5 kg during the 3 months preceding the study.
(6) Participation in any previous study with AVE0010
(7) Use of any investigational drug within 3 months prior to study
|
|
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 |
| Absolute change from baseline in HbA1c |
12 Weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change from baseline in body weight |
12 Weeks |
| Change from baseline in fasting plasma glucose |
12 Weeks |
| Change from baseline in 2-hours post-prandial plasma glucose |
12 Weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="361"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
14/05/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
14/05/2008 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
CSR |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Trial was conducted in 15 countries all over the world. A total of 28 patients were randomised from India. Data base for the study has been locked on world wide basis. |