The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin degludec

Drug: liraglutide

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01664247

U1111-1124-6612 (Other Identifier)

NN1250-3944

2011-004665-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

346 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
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)