Overview

A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Furth

Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted globally. The aim of the trial is to compare sequential addition of insulin aspart versus further dose increase with insulin degludec/liraglutide in subjects with type 2 diabetes mellitus, previously treated with insulin degludec/liraglutide and metformin and in need of further intensification. This is an extension to trial NN9068-3952, NCT01952145 (DUALâ„¢ V).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin, Globin Zinc
Insulin, Long-Acting
Liraglutide
Metformin
Xultophy
Criteria
Inclusion Criteria:

- Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin

- HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of
NN9068-3952 trial

Exclusion Criteria:

- Clinically significant diseases of the major organ systems

- Screening calcitonin above or equal to 50 ng/L