NCT01720446|CompletedPhase 3Results

Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

SUSTAIN™ 6

A Long-term, Randomised, Double-blind, Placebo-controlled, Multinational, Multi-centre Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN™ 6 - Long-term Outcomes)

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9535-37442012-002839-28U1111-1131-7227

Study Type

interventional

Target

3,297

Locations

21 countries

Sites

253

Timeline

RegisteredNov 2012

StartedFeb 2013

CompletionMar 2016

Brief Summary

This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.

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

3,297

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Feb 2013

Longer than P75 for phase_3 diabetes

Geographic Reach

21 countries

253 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

3.1 years study duration

First Submitted

Initial submission to the registry

October 29, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed

4 months until next milestone

Study Start

First participant enrolled

February 21, 2013

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2016

Completed

2 years until next milestone

Results Posted

Study results publicly available

March 15, 2018

Completed

Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

3.1 years

First QC Date

October 29, 2012

Results QC Date

December 14, 2017

Last Update Submit

June 20, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
Time from randomisation up to end of follow-up (scheduled at week 109)

Secondary Outcomes (15)

Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome
Time from randomisation up to end of follow-up (scheduled at week 109)
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Time from randomisation up to end of follow-up (scheduled at week 109)
Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke
Time from randomisation up to end of follow-up (scheduled at week 109)
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)
Week 0, up to week 104
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose
Week 0, up to week 104
+10 more secondary outcomes

Study Arms (4)

Semaglutide 0.5 mg

EXPERIMENTAL

Drug: semaglutide

Semaglutide 1.0 mg

EXPERIMENTAL

Drug: semaglutide

Semaglutide placebo 0.5 mg

PLACEBO COMPARATOR

Drug: placebo

Semaglutide placebo 1.0 mg

PLACEBO COMPARATOR

Drug: placebo

Interventions

semaglutideDRUG

Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)

Semaglutide 0.5 mg

placeboDRUG

Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).

Semaglutide placebo 0.5 mgSemaglutide placebo 1.0 mg

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.