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

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• liraglutide — DRUG
  Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
• alpha-glucosidase inhibitors — DRUG
  Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
• DPP-4 inhibitors — DRUG
  Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
• meglitinides — DRUG
  Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
• SGLT-2 inhibitors — DRUG
  Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
• sulphonylurea — DRUG
  Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
• thiazolidinediones — DRUG
  Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Study Details

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.

Key Dates

Start date

Mar 28, 2016

Status verified

Jun 2020

Primary completion

Aug 5, 2019

Completion

Aug 12, 2019

Study Design

Enrollment

1,991 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Liraglutide 1.8 mg
  Add-on to metformin
• Active Comparator: OAD
  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.

Primary Outcome Measure

Time to Inadequate Glycaemic Control [ Time Frame: Weeks 26-104 ]

Locations (179)

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