Brief Summary

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

451

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Sep 2012

Geographic Reach

9 countries

86 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

1.1 years study duration

First Submitted

Initial submission to the registry

June 8, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed

3 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

October 28, 2014

Completed

Last Updated

March 8, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

June 8, 2012

Results QC Date

October 22, 2014

Last Update Submit

January 25, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
The estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Week 0 to Week 26

Secondary Outcomes (8)

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Week 0 to Week 26
Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26
Week 0 to Week 26
Change in Body Weight From Baseline to Week 26
Week 0 to Week 26
Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)
At Week 26
Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)
At Week 26
+3 more secondary outcomes

Study Arms (2)

Liraglutide

EXPERIMENTAL

Drug: liraglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutideDRUG

Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

Liraglutide

placeboDRUG

Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

Placebo

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)
Body mass index (BMI) 20-45 kg/m\^2 (both inclusive)

You may not qualify if:

Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
Impaired liver or renal function
Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)
Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
Known or suspected abuse of alcohol or narcotics

Contact the study team to confirm eligibility.