NCT01572740|CompletedPhase 3Results

Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes

A 36-week, Randomised, Multi-centre, Double-blind, Parallel Group Trial to Investigate the Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN2211-3925U1111-1122-4320JapicCTI-121802

Study Type

interventional

Target

257

Locations

1 country

Sites

Timeline

RegisteredApr 2012

StartedApr 2012

CompletionMar 2013

Brief Summary

This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

257

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Apr 2012

Geographic Reach

1 country

23 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

12 months study duration

First Submitted

Initial submission to the registry

April 4, 2012

Completed

1 day until next milestone

Study Start

First participant enrolled

April 5, 2012

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2013

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

May 23, 2014

Completed

Last Updated

February 7, 2018

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

April 4, 2012

Results QC Date

March 27, 2014

Last Update Submit

January 11, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16
Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.
Week 0, Week 16

Secondary Outcomes (11)

Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36
Week 0, Week 36
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
Week 0, Week 16
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36
Week 0, Week 36
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16
Week 0, Week 16
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36
Week 0, Week 36
+6 more secondary outcomes

Study Arms (2)

Lira+Insulin

EXPERIMENTAL

Drug: liraglutideDrug: insulin

Placebo+Insulin

PLACEBO COMPARATOR

Drug: placeboDrug: insulin

Interventions

liraglutideDRUG

Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.

Lira+Insulin

placeboDRUG

Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.

Placebo+Insulin

insulinDRUG

All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.

Lira+InsulinPlacebo+Insulin

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day
Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive)
Body Mass Index (BMI) below 45.0 kg/m\^2

You may not qualify if:

Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (MAO) inhibitors
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Known proliferative retinopathy or maculopathy requiring treatment according to the investigator
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening
Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening

Contact the study team to confirm eligibility.