Brief Summary

This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

506

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jul 2015

Geographic Reach

12 countries

117 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

1.2 years study duration

First Submitted

Initial submission to the registry

April 8, 2015

Completed

9 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed

3 months until next milestone

Study Start

First participant enrolled

July 26, 2015

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2016

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

December 7, 2017

Completed

Last Updated

March 29, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

April 8, 2015

Results QC Date

September 29, 2017

Last Update Submit

March 1, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (Glycosylated Haemoglobin)
Change in HbA1c values after 26 weeks of treatment.
Week 0, Week 26

Secondary Outcomes (4)

Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.
Weeks 0-26
Change in Body Weight
Week 0, Week 26
Responder for HbA1c Below 7.0%
After 26 weeks of treatment
Responder for HbA1c Below or Equal to 6.5 %
After 26 weeks of treatment

Study Arms (2)

IDegLira

EXPERIMENTAL

Drug: insulin degludec/liraglutide

IGlar plus IAsp

ACTIVE COMPARATOR

Drug: insulin glargineDrug: insulin aspart

Interventions

insulin degludec/liraglutideDRUG

Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.

IDegLira

insulin glargineDRUG

Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.

IGlar plus IAsp

insulin aspartDRUG

Injected s.c./subcutaneously (under the skin) before each main meal.

IGlar plus IAsp

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female, age at least 18 years at the time of signing informed consent
Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
HbA1c (glycosylated haemoglobin) 7.0-10.0% \[53mmol/mol-86mmol/mol\] (both inclusive) by central laboratory analysis
Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
Body mass index (BMI) below or equal to 40 kg/m\^2

You may not qualify if:

Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
Screening calcitonin at least 50 ng/L
History of pancreatitis (acute or chronic)
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

Contact the study team to confirm eligibility.