CTRI/2014/09/005033 [Registered on: 18/09/2014] Trial Registered Prospectively
Last Modified On:
27/11/2018
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A trial to evaluate the Efficacy and safety of semaglutide given once weekly versus insulin glargine given once daily as add on to metformin with or without sulphonylurea in subjects with type 2 diabetes ,who have not yet been treated with insulin.
Scientific Title of Study
Efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add on to metformin with or without sulphonylurea in insulin-naïve subjects with type 2 diabetes
Trial Acronym
SUSTAIN 4
Secondary IDs if Any
Secondary ID
Identifier
2013-004392-12
ClinicalTrials.gov
NN9535 3625ver 2.0 dated 05 Feb 2014
Protocol Number
U1111-1146-0211
UTN
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
Dr Raman Shetty
Designation
Director
Affiliation
Novo Nordisk India Private Ltd
Address
Plot No.32, 47 - 50 EPIP Area, Whitefield
Bangalore KARNATAKA 560 066 India
Phone
918040303200
Fax
918041119026
Email
rasy@novonordisk.com
Details of Contact Person Public Query
Name
Mr Avik Kumar Gosh
Designation
Head-Clinical Operations
Affiliation
Novo Nordisk India Private Ltd
Address
Plot No.32, 47 - 50 EPIP Area, Whitefield
Bangalore
KARNATAKA
India Bangalore KARNATAKA 560 066 India
Phone
918040303200
Fax
918041119026
Email
avkg@novonordisk.com
Source of Monetary or Material Support
Novo Nordisk AS
Primary Sponsor
Name
Novo Nordisk AS
Address
c/o Novo Nordisk India Private Ltd
Plot No.32, 47 - 50,EPIP Area, Whitefield, Bangalore - 560 066 India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NA
NA
Countries of Recruitment
Argentina Croatia France Germany India Mexico Netherlands Romania Slovakia Slovenia South Africa The former Yugoslav Republic of Macedonia United Kingdom United States of America
Sites of Study
No of Sites = 15
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr M Ashraf Ganie
All India Institute of Medical Sciences
Department of Endocrinology and Metabolism, Room no.310, 3rd Floor Biotechnology Block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi DELHI
01126593237 01126589162 ashraf.endo@gmail.com
DrPremlata Krishnamoorthy Varthakavi
B.Y.L. Nair Hospital and T.N.Medical College,
Department of Endocrinology College Building, 4th Floor, Room No. 19, Dr. A. L. Nair Road, Mumbai MAHARASHTRA
9224480560 02223080601 premavar@hotmail.com
Dr Sreenivasamurthy L
Cauvery Medical Centre Hospital
1st floor,Cinical research room,Cauvery Medical Centre Hospital,#43/2, Bellary road,
NH.7,Sahakara Nagar,
Bengaluru - 560092
Bangalore KARNATAKA
9448051046
drlsm@lcrc.in
Dr GM Prasad
Columbia Asia  Hospital - Hebbal,
Clinical Research Room,Department of endocrinology,Kirloskar Business Park, Bellary Road, Bangalore KARNATAKA
Research room,Dept of clinical pharmacy, JSS Hospital, MG Road, Mysore Mysore KARNATAKA
08212548363 08212548368 hbgowda@gmail.com
Dr M A Shekar
Krishna Rajendra Hospital (K R Hospital),
Ground floor,Endocrine dept,Tertiary Referral Center and Teaching Hospital attached to the Mysore Medical College, Mysore Medical College and Research Institute, Irwin Road, Mysore KARNATAKA
9845120106 08212420142 drsheki@gmail.com
Dr Anupam Prakash
Lady Hardinge Medical College and Smt. Sucheta Kriplani Hospital,
room no:1014;1st floor,Department of Medicine, Lady Hardinge Medical College & Smt. Sucheta Kriplani Hospital, Shahid Bhagat Singh Marg, New Delhi DELHI
01123363728 1123343984 prakashanupam@hotmail.com
Dr ND Moulick
Lokmanya Tilak Municipal Medical College and General Hospital,
Room Number- 03, First Floor, College Building
Department of Medicine, Lokmanya Tilak Municipal Medical College and General Hospital, Sion Mumbai MAHARASHTRA
02224063076 02224074624 ndmoulick@rediffmail.com
Dr Sivagnanam Nallaperumal
Prashanth Hospital,
ground floor,research room,Prashanth Hospital,77, Harrington Road, Chetpet, Chennai 600031, Chennai TAMIL NADU
04442277777 04428366770 swamydiabetes@gmail.com
Dr Shehla Sajid Shaikh Akhtar
Prince Aly Khan Hospital,
Aminabad Building, 4th Floor, Flat no. 25, Prince Aly Khan Hospital, Aga Hall, Nesbit Road, Mazagaon, Mumbai MAHARASHTRA
02223777800 02223743820 drshehla@rediffmail.com
Dr Debasish Maji
Vivekananda Institute of Medical Sciences,
1st floor,Research Room,Near Emergency Block,Ramakrishna Mission Seva Pratishthan, 99, Sarat Bose Road Kolkata WEST BENGAL
03324753636 03324754351 d.maji50@gmail.com
Details of Ethics Committee
No of Ethics Committees= 15
Name of Committee
Approval Status
"Ethics Committee Mysore Medical College & Research Institute and Associated Hospitals.Dr. M A Shekar
Submittted/Under Review
Cuavery Medical Centre Institutional Ethics Committee,Bangalore,Dr Sreenivasamurthy
Approved
Ethics Committee for Human Research, Lady Hardinge Medical College and Associated Hospitals, Shahid Bhagat Singh Marg, New Delhi-110001.Dr. Anupam Prakash
Approved
Ethics Committee, Global hospital, Room no 214, Dr. E. Borges Road, Hospital Avenue, Opposite Shirodkar High high School, Parel, Mumbai - 400012, Maharashtra.Dr Nalini Shah
Submittted/Under Review
Ethics Committee, Prashanth Hospital, 77, Harrington Road, Chetpet, Chennai 600031, Tamil Nadu ;Dr Nallaperumal
Insitutional Ethics Committee Columbia Asia Hospitals, Columbia Asia Referral hospital, Yeshwanthpur, 26/4, Brigade Gateway, Beside Metro, Malleswaram West, Bangalore 560055. Dr G M Prasad
Submittted/Under Review
Institutional Ethics Comittee,Topiwala National medical College and BYL Nair Charitable HospitalMumbai,Dr premalatha Varthakavi
Submittted/Under Review
Institutional Ethics Committe,Jivarag Mehta Smarak Health FoundationDr Parag Shah
Approved
Institutional Ethics Committee Lokmanya Tilak Municipal Medical College 2nd Floor , Room No. 17 Sion Mumbai- 400022, Maharashtra.Dr. ND Moulick
Submittted/Under Review
Institutional Ethics Committee, JSS Medical College & Hospital, 3rd Floor, JSS Medical College, Mysore 570004, Karnataka;Dr. Hathur Basavana Gowdappa
Approved
Institutional Ethics Committee, Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, 99 Sarat Bose Road, Kolkata 700026, West Bengal.Dr. Debasish Maji
Approved
Institutional Ethics Committee, Room 102, 1st Floor, Old O.T. block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029. Dr Ashraf Ganie
Submittted/Under Review
Prince Aly Khan Hospital, Institutional Ethics Committee, Aga Hall, Nesbit Road, Mazagaon, Mumbai- 400 010, Maharashtra,Dr Shaikh Shehla Sajid Akhtar
Diabetes Type 2, (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Insulin Glargine
Injected Subcutaneously once daily.Subjects will start with 10IU once daily and the dose will be adjusted according to the fasting plasma glucose-duration 30 weeks
Intervention
Semaglutide 0.5mg/week
Injected Subcutaneously;once weekly;following 4 dosesof 0.25 mgsemaglutide weeklysubjects will receive0.5 mg semaglutide weekly for 26 weeks
Intervention
Semaglutide 1.0mg/week
Injected Subcutaneously;once weekly;following 4 dosesof 0.25 mg semaglutide weekly and 4 dosesof 0.5 mg semaglutide subjects will receive 1.0 mg semaglutide weekly for 22 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
-Male or female, age ≥18 years at the time of signing informed consent
-Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with
metformin or metformin and SU (metformin ≥1500 mg or maximum tolerated dose and SU ≥ half of maximum allowed dose according to national label) for at least 90 days before screening.Stable is defined as unchanged medication and unchanged dose
-HbA1c 7.0 – 10.0% (53 - 86 mmol/mol) both inclusive
ExclusionCriteria
Details
-Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing
potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period.
-Any disorder which, in the opinion of the investigator might jeopardise subject’s safety or
compliance with the protocol
-Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a
period of 90 days before screening. An exception is short-term treatment (≤7 days in total) with
insulin in connection with intercurrent illness
-History of chronic or idiopathic acute pancreatitis
-Screening calcitonin value ≥50 ng/L
-Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome 2 (MEN2)
-Acute coronary or cerebrovascular event within 90 days before randomisation
-Heart failure, New York Heart Association Class IV
-Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator.
-Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or
squamous cell skin cancer)
-Mental inability, unwillingness or language barrier precluding adequate understanding of or
compliance with study procedures
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Change in HBA1C from baseline
week 0 and week 30
Secondary Outcome
Outcome
TimePoints
Change in
Body weight,Fasting plasma glucose (FPG),Self-measured plasma glucose,Systolic and diastolic blood pressure,Patient reported outcomes,
week 0 and week 30
Subjects who after 30 weeks treatment achieve
After 30 weeks of Treatment
Target Sample Size
Total Sample Size="1047" Sample Size from India="175" Final Enrollment numbers achieved (Total)= "1089" Final Enrollment numbers achieved (India)="83"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
A study to evaluate Efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add on to metformin with or without sulphonylurea in insulin-naïve subjects with type 2 diabetes.Globally 14 countries are participating.