| CTRI Number |
CTRI/2013/09/003999 [Registered on: 18/09/2013] Trial Registered Retrospectively |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week treatment period assessing the efficacy and safety of lixisenatide in patients with type 2 diabetes insufficiently controlled with basal insulin with or without metformin. |
| Trial Acronym |
GET GOAL LC |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EFC12382 Protocol Amend.version 1 dated 27 Sep 2013 |
Protocol Number |
| NCT01632163 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Ajit Walekar |
| Designation |
Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo (India) Limited |
| Address |
A-101 Business Square, Sir Mathuradas Vasanji Marg,
Chakala, Andheri East, MUMBAI-400 093 – INDIA
Mumbai
MAHARASHTRA
400093
India |
| Phone |
912230707824 |
| Fax |
912228278474 |
| Email |
ajit.walekar@sanofi.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajit Walekar |
| Designation |
Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo (India) Limited |
| Address |
A-101 Business Square, Sir Mathuradas Vasanji Marg,
Chakala, Andheri East, MUMBAI-400 093 – INDIA
Mumbai
MAHARASHTRA
400093
India |
| Phone |
912230707824 |
| Fax |
912228278474 |
| Email |
ajit.walekar@sanofi.com |
|
|
Source of Monetary or Material Support
|
| Sanofi-Synthelabo (India) Limited |
|
|
Primary Sponsor
|
| Name |
Sanofi Synthelabo India Limited |
| Address |
A-101 Business Square, Sir Mathuradas Vasanji Marg,
Chakala, Andheri East, MUMBAI-400 093 – INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
China
India
Republic of Korea
Russian Federation |
Sites of Study
Modification(s)
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hiren Pandya |
AMC MET Medical College and Sheth L.G General Hospital |
AMC MET Medical College and Sheth L.G General Hospital
Rambag, Maninagar
Ahmedabad-380008,
Gujarat, India
Ahmadabad
GUJARAT |
7600030986
drhirenpandya@yahoo.com |
| Sambit Das |
APOLLO HOSPITALS |
251, APOLLO HOSPITALS,SAINIK SHOOL ROAD,UNIT-15,BHUBANESWAR, 751005
Baleshwar
ORISSA |
9937848498
sambitd2001@yahoo.co.in |
| Dr Laxminarayanappa Sreenivasamurthy |
Cauvery Medical Centre Limited |
"No 43/2, NH – 7,
Bellary Road, Sahakara Nagar, Bengaluru – 560092,
Karnataka, India
Bangalore
KARNATAKA |
9448051046
8023338242
drsreenivasamurthy@gmail.com |
| Jamal Ahmad |
Centre for Diabetes and Endocrinology |
Faculty of Medicine, J.N. Medical College & Hospital AMU Aligarh - 202002
Aligarh
UTTAR PRADESH |
9412459552
jamalahmad11@rediffmail.com |
| Dr Vijay Shekar Reddy |
Gandhi Medical College |
3rd floor, Department of Endocrinology Gandhi Medical College,
Padmarao Nagar, Musheerabad,
Secunderabad, Andhra Pradesh
Hyderabad
ANDHRA PRADESH |
9849172161
drdvsreddyendo@yahoo.com |
| Jayashree Shembalkar |
Getwell Hospital & Research Institute |
Dr. Shembalkar’s Cabin, G-11, Ground floor, Khare Marg, Dhantoli, Nagpur
Nagpur
MAHARASHTRA |
7126632200
pkshembalkar@hotmail.com |
| Dr Ashok Kumar Dash |
Global Clinical Research Services, |
5th Floor, Lakdi-ka-Pool-500004
Hyderabad, ANDHRA PRADESH
Hyderabad
ANDHRA PRADESH |
9440337017
dr_ashokdash@rediffmail.com |
| Dr Sanjeev Bakshi |
Jehangir Clinical Development Pvt Ltd |
Jehangir Hospital 32 Sassoon Rd Pune-411001
Pune
MAHARASHTRA |
9730307350
jcdem1@yahoo.com |
| K A V Subrahmanyam |
King George Hospital & Andhra Medical College |
Dept of Endocrinology, Superspeciality block, King George Hospital & Andhra Medical College, Maharanipet,
Vishakhapatnam
Andhra Pradesh- 530 002
India
Visakhapatnam
ANDHRA PRADESH |
9848149536
kavsendo@yahoo.co.in |
| Dr Mohan Badgandi |
Manipal Institute of Diabetes & Endocrinology |
Department of Diabetes and Endocriniology, Manipal Hosptals, 98 Rustom Bagh Airport Road Bangalore 560017
Bangalore
KARNATAKA |
9886036426
mohan.badgandi@manipalhospitals.com |
| DrAVenkateshwar Rao |
Mediciti Hospital |
Room no.104, Mediciti Hospital, 5-922, Secretariat road Hyderabad A.P- 500063
Hyderabad
ANDHRA PRADESH |
9440040662
venky_gmc@yahoo.com |
| Dr Jayanthy Ramesh |
Osmania General Hospital |
Department of Endocrinology,"
2nd floor, Golden Jubilee Block, Osmania General Hospital, Afzalganj, Hyderabad - 500012, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH |
9848145445
4024651667
drjayanthyramesh@gmail.com |
| Sushil Gupta |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) |
Dept of endocrinology, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
9 Rae Bareli Road,
Lucknow, Uttar Pradesh- 226014
Lucknow
UTTAR PRADESH |
9415200400
sushilguptasgpgi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| AMCMETEC/Ahmedabad/PandyaHirenKumarPrabodhkant |
Approved |
| Apollo Hospitals EC/ Bhubaneswar/ Sambit Das |
Approved |
| Bio-EC/ Aligarh/ Jamal Ahmad |
Approved |
| Cauvery medical CenterEC/Bangalore/Lakshminarayanappa Sreenivasamurthy |
Approved |
| GandhiMedicalCollegeEC/Secunderabad/VijayShekerReddy |
Approved |
| GetwellEC_Nagpur_JayashriShembalkar |
Approved |
| Institutional EC/Hyderabad/Ashok Kumar Das |
Approved |
| Institutional EC/Lucknow/SushilKumarGupta |
Submittted/Under Review |
| Jehangir Clinical Development Centre Institutional Review Board EC/ Pune/ Dr. Sanjeev Bakshi |
Approved |
| KingGeorgeHospital/Visakhapatnam/KAVSubramanyam |
Approved |
| Manipal Hospital EC/Bangalore/ Mohan Badgandi |
Approved |
| MedicitiEC/Hyderabad/Dr.A.Venkateshwar Rao |
Approved |
| Osmania General HospitalEC/Hyderabad/DrJayanthyRamesh |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus (T2DM), (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lixisenatide plus basal insulin with our without metformin |
Duration: 24-week
Route of Administration: subcutaneous
injection
Dosage: 10 μg once daily
(QD) for 2 weeks then followed by the maintenance dose of 20 μg QD from V12 (week 2) up to the
end of the treatment period. |
| Comparator Agent |
Placebo plus basal insulin with our without metformin |
Duration: 24-week
Route of Administration: subcutaneous
injection
Dosage: 10 μg once daily (QD) for 2 weeks then followed by the maintenance dose of 20 μg QD from V12 (week 2) up to the end of the treatment period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
•Patients with type 2 diabetes mellitus, diagnosed at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin with or without metformin.
•Signed written informed consent
|
|
| ExclusionCriteria |
| Details |
Age less than legal age of adulthood.
HbA1c less than 7% or more than 10.5%.
Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.
If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit. History of hypoglycemia unawareness.
Body Mass Index (BMI) ≤20 kg/m².
For complete information, please contact the study team. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Absolute change of HbA1c from baseline to week 24. |
week 24. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effects of lixisenatide over 24 weeks on percentage of patients reaching HbA1c7% or ≤6.5%, 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profile), body weight, change in daily basal insulin dose. |
week 24 |
|
|
Target Sample Size
|
Total Sample Size="432"
Sample Size from India="108"
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 3 |
|
Date of First Enrollment (India)
|
10/03/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/10/2012 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet available. CSR will be generated at the end of trial. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a randomized, double-blind, placebo-controlled,
2-arm parallel-group, multicenter study with a 24-week treatment period
assessing the efficacy and safety of lixisenatide in patients with type 2
diabetes insufficiently controlled with basal insulin with or without metformin
that will be conducted in 18 Sites in India. China has 30 Sites, Russia has 7
sites and South Korea has 7 sites. The Primary objective is to assess the
effects on glycemic control of lixisenatide in comparison to placebo as an
add-on treatment to basal insulin with or without metformin in terms of HbA1c
reduction over a period of 24 weeks in insufficiently controlled type 2
diabetic patients. The Secondary objective is to assess lixisenatide safety and
tolerability, anti-lixisenatide antibody
development and the effects of
lixisenatide over 24 weeks on following parameters:
• Percentage
of patients reaching HbA1c<7% or ≤6.5%,
• 2-hour
postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during
standardized meal challenge test,
• Fasting
plasma glucose (FPG),
• Change in
7-point self-monitored plasma glucose (SMPG) profile,
• Body
weight,
• Change in
daily basal insulin doses,
• Percentage
of patients with HbA1c<7% and no symptomatic hypoglycemia, percentage of
patients with HbA1c<7% and no body weight gain and percentage of patients
with HbA1c<7% and no symptomatic hypoglycemia and no body weight gain.
|