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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)

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ClinicalTrials.gov Identifier: NCT01959529
Recruitment Status : Completed
First Posted : October 10, 2013
Results First Posted : November 17, 2017
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec Drug: insulin glargine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7637 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
Actual Study Start Date : October 29, 2013
Actual Primary Completion Date : October 16, 2016
Actual Study Completion Date : October 16, 2016

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: insulin degludec
Injected once daily subcutaneously (s.c., under the skin)
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.
 Drug: insulin glargine
Injected once daily subcutaneously (s.c., under the skin)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Randomisation to 24 months ]
    Mean change in HbA1c from week 0 to month 24.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) 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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959529


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01959529    
Other Study ID Numbers: EX1250-4080
2013-002371-17 ( EudraCT Number )
U1111-1141-7614 ( Other Identifier: WHO )
JapicCTI-142464 ( Registry Identifier: JAPIC )
First Posted: October 10, 2013    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: July 24, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs