Brief Summary

This trial is conducted globally. The aim of the trial is to investigate efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.

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

1,991

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Mar 2016

Longer than P75 for phase_4 diabetes

Geographic Reach

10 countries

232 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

3.4 years study duration

First Submitted

Initial submission to the registry

March 23, 2016

Completed

5 days until next milestone

Study Start

First participant enrolled

March 28, 2016

Completed

9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2019

Completed

11 months until next milestone

Results Posted

Study results publicly available

July 7, 2020

Completed

Last Updated

July 7, 2020

Status Verified

June 1, 2020

Enrollment Period

3.4 years

First QC Date

March 23, 2016

Results QC Date

June 16, 2020

Last Update Submit

June 16, 2020

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Time to Inadequate Glycaemic Control
Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104.
Weeks 26-104

Secondary Outcomes (22)

Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control)
Weeks 0-104
Change in HbA1c
Week 0, week 104/premature treatment discontinuation
Participants Who Achieve HbA1c ≤6.5% (Yes/No)
Week 104/Premature treatment discontinuation
Participants Who Achieve HbA1c ≤7.0% Without Weight Gain
Week 104/Premature treatment discontinuation
Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes
Week 104/Premature treatment discontinuation
+17 more secondary outcomes

Study Arms (2)

Liraglutide 1.8 mg

EXPERIMENTAL

Add-on to metformin

Drug: liraglutide

OAD

ACTIVE COMPARATOR

Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.

Drug: alpha-glucosidase inhibitorsDrug: DPP-4 inhibitorsDrug: meglitinidesDrug: SGLT-2 inhibitorsDrug: sulphonylureaDrug: thiazolidinediones

Interventions

liraglutideDRUG

Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Liraglutide 1.8 mg

alpha-glucosidase inhibitorsDRUG

Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

OAD

DPP-4 inhibitorsDRUG

Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

OAD

meglitinidesDRUG

Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

OAD

SGLT-2 inhibitorsDRUG

Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

OAD

sulphonylureaDRUG

Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

OAD

thiazolidinedionesDRUG

Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

OAD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.