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
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec
Drug: insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 7500
Study Start Date: October 2013
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959529

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Show 280 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01959529     History of Changes
Other Study ID Numbers: EX1250-4080, 2013-002371-17, U1111-1141-7614
Study First Received: October 8, 2013
Last Updated: September 16, 2014
Health Authority: Algeria: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Canada: Health Canada
Croatia: Ministry of Health and Social Care
Greece: National Organization of Medicines
India: Ministry of Health
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Serbia: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health
Thailand: Ministry of Public Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014