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 (LIRA-PRIME)

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: thiazolidinediones; Drug: liraglutide; Drug: SGLT-2 inhibitors; Drug: alpha-glucosidase inhibitors; Drug: sulphonylurea; Drug: DPP-4 inhibitors; Drug: meglitinides

Study type: Interventional

Funder types: Industry

Identifiers

NCT02730377

NN2211-4232

2015-002417-29 (EudraCT Number)

U1111-1170-7035 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,991 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,991 participants in 2 patient groups

Liraglutide 1.8 mg

Experimental group

Description:

Add-on to metformin

Treatment:

Drug: liraglutide

OAD

Active Comparator group

Description:

Add-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.

Treatment:

Drug: DPP-4 inhibitors

Drug: alpha-glucosidase inhibitors

Drug: thiazolidinediones

Drug: meglitinides

Drug: SGLT-2 inhibitors

Drug: sulphonylurea