Trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes
Scientific Title of Study
A long-term, randomised, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes (SUSTAIN™ 6 – Long term outcomes)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
2012-002839-28
EudraCT
NCT01720446
ClinicalTrials.gov
NN9535-3744 ver 2.0 dated 02 Oct 2012
Protocol Number
U1111-1131-7227
UTN
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Bipin Kumar Sethi
Designation
Consultant Endocrinologist
Affiliation
CARE Hospital,
Address
Department of endocrinology, Door No 8-2-620/A, ground floor, Babu Khan Chambers
Road No. 10, Banjara Hills
Argentina Australia Bulgaria Canada Germany India Israel Italy Poland Russian Federation Spain Thailand Turkey United Kingdom United States of America
Sites of Study
No of Sites = 14
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Mohd Ashraf Ganie
All India Institute of Medical Sciences
Department of Endocrinology & Metabolism, Biotechnology Block, Ansar Nagar – VI Floor, Ward No. AB6, Seminar Room, Main Building.PIN-110 029
New Delhi DELHI
01126593237 01126589162 ashraf.endo@gmail.com
Dr Harish Kumar
Amrita Institute of Medical Sciences & Research Centre,
AIMS - Ponekkara P.O. – III Floor, B-Block, Department of Endocrinology & Diabetes Ernakulam KERALA
Ethics Committee for Research on Human Subjects ,Old Hospital Building, 2nd Floor, Room No. 46, Next to Medicine Seminar Hall, Seth G.S. Mediacal College & K.E.M. Hospital,Acharya Donde Marg, Parel, Mumbai - 400 012,Dr. Tushar Bandgar
Approved
Ethics Committee of All India Institute of Medical Sciences,EC ADDRESS,Dr. Mohd. Ashraf Ganie
Not Applicable
Institutional Ethical Review Board,St.Johns Medical College & Hospital, Sarjapur Road, Koramangala,Bangalore - 560 034 Dr. Ganapathi Bantwal
Drug: semaglutide,Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c. under the skin)
upto max of up to week 143
Intervention
Semaglutide 1.0 mg
Drug: semaglutide.Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)upto max of up to week 143
Comparator Agent
Semaglutide placebo 0.5 mg
Drug: placebo. Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).upto max of up to week 143
Comparator Agent
Semaglutide placebo 1.0 mg
Drug: placebo. Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).upto max of up to week 143
Inclusion Criteria
Age From
50.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Men and women with type 2 diabetes mellitus
2. Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease
3.Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs
4. HbA1c above or equal to 7.0% at screening
ExclusionCriteria
Details
1. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening
2. History of chronic pancreatitis or idiopathic acute pancreatitis
3. An acute coronary or cerebro-vascular event within the previous 14 days from Visit 2 (week 0)
4. Currently planned coronary, carotid or peripheral artery revascularisation
5. Chronic heart failure New York Heart Association (NYHA) class IV
6. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
7. Personal history of non-familial medullary thyroid carcinoma
8. Screening calcitonin above or equal to 50 ng/L
9. Type 1 diabetes mellitus
10. Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening
11. Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening
12. Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Time from randomisation to first occurrence of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.
Time from randomisation up to end of follow-up (up to max. 148 weeks)
Secondary Outcome
Outcome
TimePoints
•Time from randomisation to first occurrence of an expanded composite cardiovascular outcome.
Time from randomisation up to end of follow-up (up to max. 148 weeks)
•Time from randomisation to each individual component of the expanded composite cardiovascular outcome.
Time from randomisation up to end of follow-up (up to max. 148 weeks)
•Change from baseline to last assessment during the treatment period in other treatment outcomes: glycosylated haemoglobin (HbA1c).
Week 0, up to week 143
•Change from baseline to last assessment during the treatment period in other treatment outcomes: fasting plasma glucose.
Week 0, up to week 143
•Change from baseline to last assessment during the treatment period in other treatment outcomes: body weight.
Week 0, up to week 143
•Incidence during the treatment period in other treatment outcomes: hypoglycaemic events.
Week 0 - 143
•Incidence during the treatment period in other treatment outcomes: adverse events.
Weeks 0-143
•Occurrence during the treatment period in other treatment outcomes: anti-semaglutide antibodies.
Weeks 0-143
•Change from baseline to last assessment during the treatment period in other treatment outcomes: patient reported outcome (PRO).
Week 0, up to week 143
Target Sample Size
Total Sample Size="3260" Sample Size from India="400" 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)
21/02/2013
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
21/02/2013
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="3" Months="4" Days="10"
Recruitment Status of Trial (Global)
Completed
Recruitment Status of Trial (India)
Other (Terminated)
Publication Details
NA
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This trial was unable to start in India due to unable to obtain HA approval however this trial has been globally completed on 15 Mar 2016