The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• insulin degludec/liraglutide — DRUG
  Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial.
• liraglutide — DRUG
  Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
• exenatide — DRUG
  Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.

Study Details

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

Key Dates

Start date

Aug 29, 2012

Status verified

Dec 2018

Primary completion

Mar 11, 2014

Completion

Mar 11, 2014

Study Design

Enrollment

438 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Insulin degludec/liraglutide + OADs
• Active Comparator: Liraglutide or exenatide + OADs

Primary Outcome Measure

Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2) [ Time Frame: Week 0, week 26 ]

Locations (85)

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