At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes mellitus
- ✓HbA1c between 7.0% and 9.0% (53–75 mmol/mol)
- ✓Stable sulphonylurea dose (≥50% of max approved) ± metformin (≥1500 mg or max tolerated) for ≥90 days
- ✓BMI ≤40 kg/m²
- ✕Any other oral anti-diabetic drugs (other than SU ± metformin) within 90 days of screening
- ✕Prior GLP-1 receptor agonist therapy (e.g. exenatide, liraglutide)
- ✕Any prior or current insulin regimen (except short-term for intercurrent illness at investigator discretion)
- ✕Personal or family history of medullary thyroid carcinoma or MEN2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy
In Brief
A Phase 3 clinical trial evaluating insulin degludec/liraglutide and placebo for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 435 participants across 87 sites in 8 countries.
Detailed Summary
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.
Study Details
Timeline
Interventions
Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
Injected subcutaneously (under the skin) once daily.