Brief Summary

This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.

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

346

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Oct 2012

Geographic Reach

11 countries

132 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

1.2 years study duration

First Submitted

Initial submission to the registry

August 10, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed

2 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2013

Completed

2.3 years until next milestone

Results Posted

Study results publicly available

April 20, 2016

Completed

Last Updated

September 25, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

August 10, 2012

Results QC Date

October 23, 2015

Last Update Submit

August 25, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
Change from baseline in HbA1c after 26 weeks of treatment
Week 0, week 26

Secondary Outcomes (8)

Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, week 26
Number of Responders for HbA1c (Below 7.0 %)
After 26 weeks of randomised treatment.
Change From Baseline in Mean Pre-breakfast Measurements Used for Titration
Week 0, week 26
Change From Baseline in 8-point Profile
Week 0, week 26
Change From Baseline in Mean of the 8-point Profile
Week 0, week 26
+3 more secondary outcomes

Study Arms (2)

IDeg + Lira

EXPERIMENTAL

Drug: insulin degludecDrug: liraglutide

Placebo + Lira

EXPERIMENTAL

Drug: placeboDrug: liraglutide

Interventions

insulin degludecDRUG

Administered s.c. (under the skin) once daily. Dose individually adjusted.

IDeg + Lira

placeboDRUG

Administered s.c. (under the skin) once daily. Dose individually adjusted.

Placebo + Lira

liraglutideDRUG

Administered s.c. (under the skin) once daily. Dose: 1.8 mg.

IDeg + LiraPlacebo + Lira

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Insulin naïve
Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID))
Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID)

You may not qualify if:

Calcitonin equal to or above 50 pg/mL
Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)

Contact the study team to confirm eligibility.