Brief Summary

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

438

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Aug 2012

Typical duration for phase_3 diabetes

Geographic Reach

5 countries

109 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

1.5 years study duration

First Submitted

Initial submission to the registry

August 28, 2012

Completed

1 day until next milestone

Study Start

First participant enrolled

August 29, 2012

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2014

Completed

4.3 years until next milestone

Results Posted

Study results publicly available

July 9, 2018

Completed

Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

1.5 years

First QC Date

August 28, 2012

Results QC Date

March 22, 2018

Last Update Submit

December 7, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
Week 0, week 26

Secondary Outcomes (8)

Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Week 26
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Week 26
Change From Baseline in Body Weight
Week 0, week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, week 26
Number of Severe or Minor Hypoglycaemic Episodes
After 26 weeks of treatment
+3 more secondary outcomes

Study Arms (2)

Insulin degludec/liraglutide + OADs

EXPERIMENTAL

Drug: insulin degludec/liraglutide

Liraglutide or exenatide + OADs

ACTIVE COMPARATOR

Drug: liraglutideDrug: exenatide

Interventions

insulin degludec/liraglutideDRUG

Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial.

Insulin degludec/liraglutide + OADs

liraglutideDRUG

Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.

Liraglutide or exenatide + OADs

exenatideDRUG

Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.

Liraglutide or exenatide + OADs

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects with type 2 diabetes mellitus
Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
BMI (body mass index) equal to or below 40 kg/m\^2

You may not qualify if:

Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)
Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
Screening calcitonin equal to or above 50 ng/l
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
History of chronic pancreatitis or idiopathic acute pancreatitis

Contact the study team to confirm eligibility.