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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

7,637

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Oct 2013

Longer than P75 for phase_3 diabetes

Geographic Reach

20 countries

446 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

First Submitted

Initial submission to the registry

October 8, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed

19 days until next milestone

Study Start

First participant enrolled

October 29, 2013

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2016

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 17, 2017

Completed

Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

October 8, 2013

Results QC Date

October 16, 2017

Last Update Submit

July 10, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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 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.
From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)

Secondary Outcomes (3)

Number of EAC-confirmed Severe Hypoglycaemic Episodes
From randomisation to individual end of trial (maximum patient year observation: 2.75 years)
Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no)
From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)
Change in Glycosylated Haemoglobin (HbA1c)
Randomisation to 24 months

Study Arms (2)

Insulin degludec (IDeg)

EXPERIMENTAL

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

Insulin glargine (IGlar)

ACTIVE COMPARATOR

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

Interventions

insulin degludecDRUG

Injected once daily subcutaneously (s.c., under the skin)

Insulin degludec (IDeg)

insulin glargineDRUG

Injected once daily subcutaneously (s.c., under the skin)

Insulin glargine (IGlar)

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.