A trial comparing cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events

• Register: EUCTR
• Last refreshed on: 9 January 2017
• Main ID: EUCTR2013-002371-17-HR
• Date of registration: 24/01/2014
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: A trial 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: 13/01/2014
• Target sample size: 7500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002371-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Algeria, Argentina, Brazil, Canada, Croatia, European Union, Greece, India, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Poland, Russian Federation, South Africa, Spain, Thailand, United Kingdom, United States

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
- Type 2 diabetes
- Age = 50 years with predefined previous cardiovascular disease(s) or renal disease or age = 60 years with predefined cardiovascular risk factors
- HbA1c = 7.0% or HbA1c < 7.0% and current insulin treatment corresponding to = 20 U of basal insulin per day.
- One or more oral or injectable antidiabetic agent(s)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5250

Exclusion criteria:
- An acute coronary or cerebrovascular event in the previous 60 days
- Planned coronary, carotid or peripheral artery revascularisation
- Chronic heart failure NYHA 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:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2
MedDRA version: 17.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Trade Name: Lantus® 100 units/ml solution for injection in a vial
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Product Name: insulin degludec
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: The primary objective is to confirm the cardiovascular safety of insulin degludec compared to that of insulin glargine.

Timepoint(s) of evaluation of this end point: From randomisation to 60 months

Secondary Objective: The secondary objectives are to assess efficacy of insulin degludec on markers of glycaemic control and to assess safety on other parameters in subjects with type 2 diabetes at high risk of cardiovascular events.

Primary end point(s): 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)

Timepoint(s) of evaluation of this end point: 1. Week 0 to the last assessment (60 months)
2. Week 0 to the last assessment (59 months)

Secondary end point(s): 1. Number of severe hypoglycaemic episodes
2. Change in Glycosylated haemoglobin (HbA1c)

Secondary ID(s)

EX1250-4080

2013-002371-17-GB

Source(s) of Monetary Support

Novo Nordisk A/S