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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01959529
First received: October 8, 2013
Last updated: September 16, 2014
Last verified: September 2014

October 8, 2013
September 16, 2014
October 2013
November 2018   (final data collection date for primary outcome measure)
Time from randomisation to first occurrence of a major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: From randomisation to 60 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01959529 on ClinicalTrials.gov Archive Site
  • Number of severe hypoglycaemic episodes [ Time Frame: Week 0 to the last assessment (60 months) ] [ Designated as safety issue: No ]
  • Change in Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0 to the last assessment (59 months) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin degludec
    Injected once daily subcutaneously (s.c., under the skin)
  • Drug: insulin glargine
    Injected once daily subcutaneously (s.c., under the skin)
  • Experimental: Insulin degludec (IDeg)
    All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.
    Intervention: Drug: insulin degludec
  • Active Comparator: Insulin glargine (IGlar)
    All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.
    Intervention: Drug: insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
7500
November 2018
November 2018   (final data collection date for primary outcome measure)

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)

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)
Both
50 Years and older
No
Contact: Novo Nordisk clinicaltrials@novonordisk.com
United States,   Algeria,   Argentina,   Brazil,   Canada,   Croatia,   Greece,   India,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Thailand,   United Kingdom
 
NCT01959529
EX1250-4080, 2013-002371-17, U1111-1141-7614
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP