Brief Summary

This trial is conducted globally. The aim of this trial is to investigate effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insulin.

Trial Health

On Track

Trial Health Score

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

Enrollment

396

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Feb 2017

Geographic Reach

7 countries

54 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

1.6 years study duration

First Submitted

Initial submission to the registry

November 10, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed

3 months until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

November 27, 2019

Completed

Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

November 10, 2016

Results QC Date

September 4, 2019

Last Update Submit

March 13, 2020

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (2)

Change in Body Weight (%)
Change in body weight from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
Week 0, week 56
Participants Losing at Least 5% of Baseline Body Weight
The estimated percentage of participants losing at least 5% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
Week 56

Secondary Outcomes (44)

Participants Losing More Than 10% of Baseline Body Weight at Week 56
Week 56
Change in Waist Circumference
Week 0, week 56
Change in HbA1c
Week 0, week 56
Change in FPG
Week 0, week 56
Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
Week 0, week 56
+39 more secondary outcomes

Study Arms (2)

liraglutide 3.0 mg

EXPERIMENTAL

Drug: Liraglutide 3.0 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Liraglutide 3.0 mgDRUG

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

liraglutide 3.0 mg

PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.