Trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/02/011714
• Date of registration: 05-02-2018
• Prospective Registration: No
• Primary sponsor: Novo Nordisk AS
• Public title: Trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes
• Scientific title: 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 (SUSTAINâ?¢ 6 â?? Long term outcomes)
• Date of first enrolment: 21-02-2013
• Target sample size: 3260
• Recruitment status: Other (Terminated)
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=5735
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Bulgaria, Canada, Germany, India, Israel, Italy, Poland, Russian Federation, Spain, Thailand, Turkey, United Kingdom, United States of America

Contacts

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 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


Exclusion criteria: 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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Diabetes Mellitus, Type 2 Health Condition 2: E11- Type 2 diabetes mellitus

Intervention(s)

Intervention1: Semaglutide 0.5 mg: 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

Intervention2: 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

Control Intervention1: 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

Control Intervention2: 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

Primary Outcome(s)

Time from randomisation to first occurrence of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke.Timepoint: Time from randomisation up to end of follow-up (up to max. 148 weeks)

Secondary Outcome(s)

â?¢Change from baseline to last assessment during the treatment period in other treatment outcomes: body weight.

Timepoint: Week 0, up to week 143

â?¢Change from baseline to last assessment during the treatment period in other treatment outcomes: glycosylated haemoglobin (HbA1c).

Timepoint: Week 0, up to week 143

â?¢Change from baseline to last assessment during the treatment period in other treatment outcomes: fasting plasma glucose.

Timepoint: Week 0, up to week 143

â?¢Time from randomisation to each individual component of the expanded composite cardiovascular outcome.Timepoint: Time from randomisation up to end of follow-up (up to max. 148 weeks)

â?¢Time from randomisation to first occurrence of an expanded composite cardiovascular outcome.

Timepoint: Time from randomisation up to end of follow-up (up to max. 148 weeks)

â?¢Change from baseline to last assessment during the treatment period in other treatment outcomes: patient reported outcome (PRO).

Timepoint: Week 0, up to week 143

â?¢Incidence during the treatment period in other treatment outcomes: adverse events.

Timepoint: Weeks 0-143

â?¢Occurrence during the treatment period in other treatment outcomes: anti-semaglutide antibodies.Timepoint: Weeks 0-143

â?¢Incidence during the treatment period in other treatment outcomes: hypoglycaemic events.

Timepoint: Week 0 - 143

Secondary ID(s)

U1111-1131-7227

NCT01720446

NN9535-3744 ver 2.0 dated 02 Oct 2012

2012-002839-28

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date: 22/01/2013
Contact:

Institutional Ethics Committe, Room No. 17A, 4th Floor Block F,Nehru Building, PGIMER Sector 12,Chandigarh -160 012Dr. Anil Bhansali

Status: Approved
Approval date: 31/01/2013
Contact:

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

Status: Approved
Approval date: 31/01/2013
Contact:

KEM Hospital Resesarch center Ethics Committee,Sardar Moodliar Road, Rasta Peth, Pune - 411 011,Dr. Chittaranjan Sakerlal Yajnik

Status: Approved
Approval date: 01/02/2013
Contact:

Institutional Review Board,Christian Medical College, Bagayam, Vellore - 632 002,Dr. Nihal Thomas

Status: Approved
Approval date: 03/02/2013
Contact:

Institutional Ethics Committee,CARE Foundation, CARE Hospital, Road No. 1 Banjara Hillls,Hyderabad - 500 034,Dr. Bipin Kumar Sethi

Status: Approved
Approval date: 11/02/2013
Contact:

Institutional Ethics Committee,Amrita Institue Of Medical Sciences & Research Centre, AIMS - Ponekkara P.O. Kochi - 682 041,Dr. Harish Kumar

Status: Approved
Approval date: 26/02/2013
Contact:

Institutional Ethics Committe,Nizams Institute of Mediacal Sciences University Panjagutta, Hyderabad - 500 082,Dr. Paturi Vishnupriya Rao

Status: Approved
Approval date: 22/04/2013
Contact:

Institutional Ethics Committe,B.Y.L. Nair Ch. Hospital & T.N. Medical College, G Building, Ground Floor, Dr. A.L. Nair Road Mumbai - 400 008,Dr. Nikhil Bhagwat

Status: Approved
Approval date: 02/07/2013
Contact:

Institutional Ethical Review Board,St.Johns Medical College & Hospital, Sarjapur Road, Koramangala,Bangalore - 560 034 Dr. Ganapathi Bantwal

Status: Approved
Approval date: 11/09/2013
Contact:

Madras Diabetes Research Foundation,No. 4, Conran Smith Road, Gopalapuram, Chennai - 600 086,Dr. V. Mohan

Status: Not Applicable
Approval date:
Contact:

Ethics Committee of All India Institute of Medical Sciences,EC ADDRESS,Dr. Mohd. Ashraf Ganie

Status: Not Applicable
Approval date:
Contact:

Institutional Ethics Committe,IPGME&R and SSKM Hospital, 244 A.J.C. Bose Road, Kolkata - 700 020,Dr. Subhankar Chowdhury

Status: Not Applicable
Approval date:
Contact:

Institutional Ethics Committee,Apollo Gleneagles Hospitals, 58, Canal Circular Road, Kolkata 700 054,Dr. Sanjay Chatterjee

Status: Not Applicable
Approval date:
Contact:

S.L. Raheja Hospital,Raheja Rugnalaya Marg, Mahim (West), Mumbai - 400 016,Dr. Anil Bhoraskar