Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

Dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagonlike peptide-1 (GLP-1) mimetics or analogs, which rely on the gastrointestinal hormones that are part of the incretin system for the treatment of T2DM, provide a therapeutic alternative to common oral antihyperglycemic agents (eg, sulfonylureas, thiazolidinediones).

It had two arms (groups): Vildagliptin/Metformin followed by Liraglutide+Metformin (experimental) and Liraglutide + Metformin followed by Vildagliptin/Metformin (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 62 actual participants took part.

It was open to people of any sex aged from 40 years up to 80 years.

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

Examples of who could join: Patients with type 2 diabetes. Metformin monotherapy \> 12 weeks. Body mass Index (BMI) 19-35 (kg/m²).

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: acute diseases at randomization; contraindication for gliptins or glucagon-like-peptide-analogues according to the respective summary of product characteristics (smpc); previous use of dipeptidyl peptidase-4-inhibitors and glp-1-mimetics.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2012-01 with completion listed for 2012-10.

It ran at 8 sites in Germany (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportion of patients preferring each treatment regimen (time frame: At week 24).

It also tracked 6 secondary outcomes, for example Number of patients with treatment satisfaction for each treatment measured by Diabetes Treatment Satisfaction Questionnaire (TSQM-9), Number of patients responding to subjective reasons of preference to each treatment, Change from baseline in fasting plasma glucose at 12 weeks and 24 weeks, Change From Baseline in Hemoglobin A1c (HbA1c) at week 12 and week 24 and Investigator preference and subjective reasons of preference to each treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 62 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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