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

What Was Tested

This registered phase 3 trial tested Exenatide and Liraglutide.

This trial is conducted in Europe, Oceania and the United States of America (USA).

It had two arms (groups): Insulin degludec/liraglutide + OADs (experimental) and Liraglutide or exenatide + OADs (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 438 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects with type 2 diabetes mellitus. BMI (body mass index) equal to or below 40 kg/m\^2.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: any use of oral anti-diabetic drugs (oads) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (visit 1); treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator); screening calcitonin equal to or above 50 ng/l.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

The Exenatide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

It started in 2012-08-29 with completion listed for 2014-03-11.

It ran at 109 sites in United States (85), France (8), Slovakia (7), Australia (5) and Hungary (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2) (time frame: Week 0, week 26).

It also tracked 8 secondary outcomes, for example Change From Baseline in Body Weight, Change From Baseline in Fasting Plasma Glucose (FPG), Number of Severe or Minor Hypoglycaemic Episodes, Number of Adverse Events (AEs), Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D) and Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Liraglutide in 438 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page and the Liraglutide compound page, all human trials.