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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01959529
First Posted: October 10, 2013
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
October 8, 2013
October 10, 2013
October 16, 2017
November 17, 2017
November 17, 2017
October 29, 2013
October 16, 2016   (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 individual end of trial date (maximum patient year observation: 2.75 years) ]
Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses. The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.
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 ]
Complete list of historical versions of study NCT01959529 on ClinicalTrials.gov Archive Site
  • Number of EAC-confirmed Severe Hypoglycaemic Episodes [ Time Frame: From randomisation to individual end of trial (maximum patient year observation: 2.75 years) ]
    Number of severe hypoglycaemic episodes from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.
  • Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no) [ Time Frame: From randomisation to individual end of trial date (maximum patient year observation: 2.75 years) ]
    Occurrence of at least one EAC-confirmed severe hypoglycaemic episode within a subject from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions.
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Randomisation to 24 months ]
    Mean change in HbA1c from week 0 to month 24.
  • Number of severe hypoglycaemic episodes [ Time Frame: Week 0 to the last assessment (60 months) ]
  • Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0 to the last assessment (59 months) ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7637
October 16, 2016
October 16, 2016   (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)
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   Argentina,   Brazil,   Canada,   Croatia,   Greece,   India,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Thailand,   United Kingdom,   United States
 
 
NCT01959529
EX1250-4080
2013-002371-17 ( EudraCT Number )
U1111-1141-7614 ( Other Identifier: WHO )
JapicCTI-142464 ( Registry Identifier: JAPIC )
Yes
Not Provided
Not Provided
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
October 2017

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