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 ongoing, but not recruiting participants.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01959529
First received: October 8, 2013
Last updated: January 28, 2015
Last verified: January 2015
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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 ]
| Enrollment: | 7644 |
| 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
Show 274 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01959529
Show 274 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: | January 28, 2015 |
| 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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Glargine |
Insulin Insulin, Globin Zinc Insulin, Long-Acting Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015