Brief Summary

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide 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

819

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Nov 2015

Longer than P75 for phase_3 diabetes

Geographic Reach

1 country

76 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

2.1 years study duration

First Submitted

Initial submission to the registry

November 16, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed

Same day until next milestone

Study Start

First participant enrolled

November 18, 2015

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2017

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

July 29, 2019

Completed

Last Updated

April 9, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

November 16, 2015

Results QC Date

December 7, 2018

Last Update Submit

March 10, 2021

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira
Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira).
Week 0, Week 52

Secondary Outcomes (39)

Change From Baseline in Body Weight (kg)
Week 0, Week 52
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes
Weeks 0-52
Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg
Week 0, Week 52
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, Week 52
Insulin Dose
After 52 weeks of treatment
+34 more secondary outcomes

Study Arms (3)

Insulin degludec/liraglutide OD

EXPERIMENTAL

Drug: insulin degludec/liraglutide

Insulin degludec OD

ACTIVE COMPARATOR

Drug: insulin degludec

Liraglutide OD

ACTIVE COMPARATOR

Drug: liraglutide

Interventions

insulin degludec/liraglutideDRUG

Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.

Insulin degludec/liraglutide OD

insulin degludecDRUG

Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.

Insulin degludec OD

liraglutideDRUG

Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.

Liraglutide OD

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female Japanese subjects, age at least 20 years at the time of signing informed consent
Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
Body-mass index (BMI) above or equal to 20 kg/m\^2
Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling

You may not qualify if:

Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)
Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism
Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal
Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Screening calcitonin equal to 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

Contact the study team to confirm eligibility.