A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events - Full Text View

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 Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Insulin Insulin human Insulin glargine Insulin degludec

U.S. FDA Resources

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 38 months ]

Secondary Outcome Measures:

Number of severe hypoglycaemic episodes [ Time Frame: Week 0 to the last assessment (38 months) ]
Change in Glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0 to the last assessment (37 months) ]


Enrollment:	7637
Actual Study Start Date:	October 29, 2013
Study Completion Date:	October 16, 2016
Primary Completion Date:	October 16, 2016 (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 (Adult, Senior)
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

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 447 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:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Publications:

Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Frandsen KB, Rabøl R, Buse JB. Design of DEVOTE (Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events) - DEVOTE 1. Am Heart J. 2016 Sep;179:175-83. doi: 10.1016/j.ahj.2016.06.004. Epub 2016 Jun 18.

Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr PM, Lange M, Brown-Frandsen K, Moses A, Skibsted S, Kvist K, Buse JB; DEVOTE Study Group. Efficacy and Safety of Degludec versus Glargine in Type 2 Diabetes. N Engl J Med. 2017 Jun 12. doi: 10.1056/NEJMoa1615692. [Epub ahead of print]


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01959529 History of Changes
Other Study ID Numbers:	EX1250-4080 2013-002371-17 ( EudraCT Number ) U1111-1141-7614 ( Other Identifier: WHO ) JapicCTI-142464 ( Registry Identifier: JAPIC )
Study First Received:	October 8, 2013
Last Updated:	June 21, 2017

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin, Globin Zinc	Insulin Insulin Glargine Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017

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