Clinical trial NCT01518101: Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications
Official title: A Randomized, Open-label, Cross-over Study to Evaluate Patient Preferences for Eucreas® Versus Victoza® as add-on to Metformin in Type 2 Diabetes Mellitus Patients Who Did Not Have Adequate Glycaemic Control With Metformin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: patient preference
vildagliptin
liraglutide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 62
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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). Although GLP-1 analogs and DPP-4 inhibitor medications are effective, there are differences between these products, including method of administration (injectable versus oral). Previous studies have shown that patients prefer additional oral agents over injectable agents because of fear of injections and the desire to avoid them. Patient preference is both clinically and financially important, as it can have long-term implications in terms of patients' motivation and insight into their disease state and its treatment, which might have a direct impact on the patient's compliance and treatment adherence. The aim of the current study is to evaluate the proportion of T2DM patients preferring oral anti-diabetic treatment with vildagliptin + metformin versus an injectable anti-diabetic treatment with liraglutide after 4 weeks of treatment with each medication.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes
* Metformin monotherapy \> 12 weeks
* Hemoglobin A1c (HbA1c) \> 6.5 % and \< 9.0 %
* Body mass Index (BMI) 19-35 (kg/m²)

Exclusion Criteria:

* acute diseases at randomization
* kidney diseases with creatinin \> 120 µmol/l, glomerular filtration rate (GFR) \<50 ml/min
* 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

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Proportion of patients preferring each treatment regimen
timeFrame: At week 24
Secondary outcomes:
measure: Number of patients with treatment satisfaction for each treatment measured by Diabetes Treatment Satisfaction Questionnaire (TSQM-9)
timeFrame: week 12, Week 24
measure: Number of patients responding to subjective reasons of preference to each treatment
timeFrame: Week 12, week 24
measure: Number of patients with adverse event, serious adverse events and death
timeFrame: 24 weeks
measure: Change from baseline in fasting plasma glucose at 12 weeks and 24 weeks
timeFrame: From Baseline to 12 weeks and 24 weeks
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at week 12 and week 24
timeFrame: From Baseline to 12 weeks and 24 weeks
measure: Investigator preference and subjective reasons of preference to each treatment
timeFrame: Week 12, week 24
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Falkensee
country: Germany
facility: Novartis Investigative Site
city: Meissen
country: Germany
facility: Novartis Investigative Site
city: Neunkirchen
country: Germany
facility: Novartis Investigative Site
city: Saarlouis
country: Germany
facility: Novartis Investigative Site
city: Völlkingen
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ludemann J, Dutting ED, Dworak M. Patient preference and tolerability of a DPP-4 inhibitor versus a GLP-1 analog in patients with type 2 diabetes mellitus inadequately controlled with metformin: a 24-week, randomized, multicenter, crossover study. Ther Adv Endocrinol Metab. 2015 Aug;6(4):141-8. doi: 10.1177/2042018815595584.