Brief Summary

This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes mellitus.

Trial Health

On Track

Trial Health Score

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

Enrollment

635

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Jul 2015

Longer than P75 for phase_3 diabetes

Geographic Reach

1 country

47 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

2.3 years study duration

First Submitted

Initial submission to the registry

July 21, 2015

Completed

Same day until next milestone

Study Start

First participant enrolled

July 21, 2015

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2017

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2017

Completed

8 months until next milestone

Results Posted

Study results publicly available

June 25, 2018

Completed

Last Updated

September 5, 2018

Status Verified

July 1, 2018

Enrollment Period

1.8 years

First QC Date

July 21, 2015

Results QC Date

April 26, 2018

Last Update Submit

July 31, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.
Week 0, Week 26

Secondary Outcomes (60)

Change in HbA1c (Week 52)
Week 0, Week 52
Responder for HbA1c Below 7.0% (53 mmol/Mol)
Week 26 and Week 52
Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Week 26 and Week 52
Responder for HbA1c Below 7.0% Without Weight Gain
Week 26 and Week 52
Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Week 26 and Week 52
+55 more secondary outcomes

Study Arms (2)

Liraglutide 1.8 mg

EXPERIMENTAL

The total trial duration for the 1.8 mg/day treatment arm will be approximately 67 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week main treatment period, a safety extension period of 26 weeks and a follow-up visit.

Drug: liraglutide

Liraglutide 0.9 mg

ACTIVE COMPARATOR

The total trial duration for the 0.9 mg/day treatment arm will be approximately 41 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week treatment period, and a follow-up visit.

Drug: liraglutide

Interventions

liraglutideDRUG

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

Liraglutide 0.9 mgLiraglutide 1.8 mg

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female Japanese subjects at least 20 years of age at the time of informed consent
Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
HbA1c 7.5-10.0% \[58 mmol/mol-86 mmol/mol\] (both inclusive)
Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling

You may not qualify if:

Treatment with insulin within 12 weeks prior to screening
Screening calcitonin equal or above 50 ng/l
History of pancreatitis (acute or chronic)
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
Subjects presently classified as being in New York Heart Association (NYHA) Class IV
Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol

Contact the study team to confirm eligibility.