Overview

Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes

Status:
Completed
Trial end date:
2019-08-12
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted globally. The aim of the trial is to investigate efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
2,4-thiazolidinedione
Dipeptidyl-Peptidase IV Inhibitors
Glycoside Hydrolase Inhibitors
Liraglutide
Meglitinide
Metformin
Sodium-Glucose Transporter 2 Inhibitors
Criteria
Inclusion Criteria: - Male or female at least 18 years of age at the time of signing
informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above
90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal
to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit -
HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior
to the screening visit Exclusion Criteria: - Female who is pregnant, breast-feeding or
intends to become pregnant or is of childbearing potential and not using adequate
contraceptive methods (adequate contraceptive measures as required by local regulation or
practice) - Treatment with any medication for the indication of diabetes other than
metformin in a period of 60 days before the screening visit. An exception is short-term
treatment (below or equal to 7 days in total) with insulin in connection with intercurrent
illness - Receipt of any investigational medicinal product within 30 days before the
screening visit - Any disorder, which in the investigator's opinion might jeopardise
subject's safety or compliance with the protocol