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

• Status: Completed
• Trial end date: 2013-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting; Liraglutide; Metformin

Criteria

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)