A Trial for Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/03/004505
• Date of registration: 27-03-2014
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk AS
• Public title: A Trial for Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
• Scientific title: A trial comparing cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events - DEVOTE
• Date of first enrolment: 27-03-2014
• Target sample size: 7500
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8316
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

Algeria, Argentina, Brazil, Canada, Croatia, Democratic People's Republic of Korea, Greece, India, Italy, Japan, Malaysia, Mexico, Poland, Romania, Russian Federation, Serbia , South Africa, Spain, Thailand, Ukraine, United Kingdom, United States of America

Contacts

• Name: Mr Avik Kumar Gosh
• Affiliation: Novo Nordisk India Private Ltd

• Name: Dr Raman Shetty
• Affiliation: Novo Nordisk India Private Ltd

Key inclusion & exclusion criteria

Inclusion criteria:

•Type 2 diabetes

•Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors

•HbA1c (Glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day

•One or more oral or injectable antidiabetic agent(s)

50 Years and above




Exclusion criteria:

•An acute coronary or cerebrovascular event in the previous 60 days

•Planned coronary, carotid or peripheral artery revascularisation

•Chronic heart failure NYHA (New York Heart Association) class IV

•Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)



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: Insulin degludec (IDeg): Drug: insulin degludec
Injected once daily subcutaneously (s.c., under the skin)
Duration: 60 Months
Control Intervention1: Insulin glargine (IGlar): Drug: insulin glargine
Injected once daily subcutaneously (s.c., under the skin)
Duration:60 Months

Primary Outcome(s)

Time from randomisation to first occurrence of a major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or non-fatal strokeTimepoint: Time from randomisation to first occurrence of a major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke

Secondary Outcome(s)

Change in Glycosylated haemoglobin (HbA1c)Timepoint: Week 0 to the last assessment (59 months)

Number of severe hypoglycaemic episodesTimepoint: Week 0 to the last assessment (60 months)

Secondary ID(s)

NCT01959529

U1111-1141-7614

2013-002371-17

EX 1250-4080 Version No: 2.0 dated 19 July 2013

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date: 21/11/2013
Contact:

Ethics committee of Manipal Hospitals,Manipal Hospital, # 98, HAL Airport Road, Bangalore-560017,Dr Arpandev Bhattacharyya

Status: Approved
Approval date: 30/12/2013
Contact:

Institutional Ethics Committee,Apollo Gleneagles Hospital, Kolkata, 58, Canal Circular Road, Kolkata-700 054,Dr Tirthankar Chaudhury

Status: Approved
Approval date: 08/01/2014
Contact:

Ethics Committee,All India Institute of Medical Sciences, Room no. 102, Ist Floor, OT Block,Dr Nikhil Tandon

Status: Approved
Approval date: 15/01/2014
Contact:

K. Govindaswamy Naidu Medical Trust, Institutional Ethics Committee,K. G. Hospital, Gov. Arts College Road, Coimbatore-641018, Tamil Nadu.Dr. Girithara Gopalakrishnan Jayaram Naidu

Status: Approved
Approval date: 19/01/2014
Contact:

Institutional Ethics Committee,CARE Foundation, CARE Convergence Centre,Dr MazherAli

Status: Approved
Approval date: 07/02/2014
Contact:

Ethics Committee,Inamdar Multispeciality Hospital, Hospital Building, S. No. 15, Fatima Nagar, Pune-411040, Maharashtra, India.Dr Shailaja Kale

Status: Approved
Approval date: 07/02/2014
Contact:

Institutional Ethics Committee,Apollo Gleneagles Hospital Kolkata

Status: Approved
Approval date: 20/02/2014
Contact:

Ethics Committee for Human Research ,Lady Hardinge Medical & Associated Hospitals, Shivaji Marg, New Delhi-110001, India.Dr Anupam Prakash

Status: Approved
Approval date: 20/02/2014
Contact:

Ethics Committee,Apollo Hospital Bhubaneswar, Ist Floor, Quality Office, Apollo Hospitals, Bhubaneswar, Plot No. 215, Sainik School Road, Unit 15, Samantapuri, Bhubaneswar-751005,Dr Sambit Das

Status: Approved
Approval date: 20/02/2014
Contact:

Institutional Ethics Committee,Poona Medical Research Foundation Pune. E4-C to E4-F, 4th Floor, Fifth Avenue, Pune-411001,Dr Mutha Abhay Amrutlal

Status: Approved
Approval date: 12/03/2014
Contact:

Institutional Ethics Committee,Fortis Hospital ,Dr K. P. Singh

Status: Approved
Approval date: 27/03/2014
Contact:

Institutional Ethics Committee,B. J. Medical College & Civil Hospital, Ahmedabad-380016.Dr Asha N. Shah

Status: Approved
Approval date: 01/04/2014
Contact:

The JMSHF and BMRC Independent Ethics Committee,Research department, The Jivraj Mehta Hospital, Dr. Jivraj Mehta Marg, Ahmedabad â?? 380 007

Status: Approved
Approval date: 11/04/2014
Contact:

Ethics Committee,Govt. Medical College, Kozhikode, 4th Floor, Golden Jubilee Annex, Institute of Maternal and Child Health, Calicut-673008, Kerela.Dr R. Chandni

Status: Approved
Approval date: 19/04/2014
Contact:

Institutional Ethics Committee,Goa Medical College, Bambolim-Complex, Goa- 403202.Dr Ankush Desai

Status: Approved
Approval date: 20/04/2014
Contact:

Institutional Ethics Committee,Sterling Hospital, 8th Floor, Sterling Hospital Road, Memnagar, Ahmedabad-380052, Gujarat, India.Dr Sanjeev Phatak

Status: Approved
Approval date: 28/04/2014
Contact:

Ethics Committee, Prashanth Hospital, #77, Harrington Road, Chetpet,

Status: Approved
Approval date: 08/05/2014
Contact:

Ethics Committee,Dr RML Hospital, Talkatora Road,Dr Bindu Kulshreshtha

Status: Approved
Approval date: 09/05/2014
Contact:

Institutional Ethics Committee,St. Johns Medical College & Hospital Institutional Ethics Committee, Ground Floor, St. Johnâ??s Medical College, Sarjapur Road,Dr Vivek Mathew

Status: Approved
Approval date: 16/05/2014
Contact:

Institutional Ethics Committee,Prince Aly Khan Hospital, Aga hall, Nesbit Road, Mazagaon, Mumbai-400010.Dr Shaikh Shehla Sajid Akhtar

Status: Approved
Approval date: 21/05/2014
Contact:

IPGME&R Research Oversight Committee,Office of the Dean, College Building, 5th Floor,Institute of Post graduate Medical Education & Research,Dr Subhankar Chowdhury

Status: Approved
Approval date: 12/06/2014
Contact:

Institutional Ethics Committee,

Status: Approved
Approval date: 26/07/2014
Contact:

HCG Multispeciality Ethics Committee,HCG Multispeciality hospital,Mithakhali, Ellisbridge,Ahmedabad- 380 006Dr Tiven Marwah

Status: Approved
Approval date: 04/08/2014
Contact:

Medanta Institutional Ethics Committee,Medanta The Medicity, Sec-38, Gurgaon, Haryana, India.Dr Ambrish Mithal

Status: Approved
Approval date: 27/08/2014
Contact:

Institutional Ethics Committee,Lokmanya Tilak Municipal Medical College

Status: Approved
Approval date: 12/09/2014
Contact:

Independent Ethics Committee of Madras Diabetes Research Foundation, #4Conran Smith Road, Gopalapuram, Chennai- 600 086, Tamilnadu INDIA

Results

• Date Completed: 26/11/2014